NIH launches trial of investigational genital herpes vaccine

Researchers have launched an early-stage clinical trial of an investigational vaccine designed to prevent genital herpes disease. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring the Phase I trial, which is being conducted at the NIH Clinical Center in Bethesda, Md.

Genital herpes is one of the most common sexually transmitted infections in the United States. Most genital herpes cases are caused by infection with herpes simplex virus type 2 (HSV-2); however, herpes simplex virus type 1 (HSV-1) can also cause genital herpes. An estimated 776,000 people in the United States are infected with HSV-2 or HSV-1 each year. There is no vaccine to prevent genital herpes.

“Although genital herpes is treatable, it is a lifelong infection that can exact a substantial psychological and physical toll on infected individuals and places them at higher risk of acquiring HIV,” said NIAID Director Anthony S. Fauci, M.D. “Furthermore, mothers with active genital herpes infection at time of delivery can transmit the virus to their newborns, which can lead to severe illness and death.”

“A protective vaccine would help to reduce significantly the spread of this all-too- common sexually transmitted infection,” Fauci added.

Led by principal investigator Lesia K. Dropulic, M.D., of NIAID’s Laboratory of Infectious Diseases, the trial will test an investigational HSV-2 vaccine candidate, called HSV529, for safety and the ability to generate an immune system response. The investigational vaccine manufactured by Sanofi Pasteur was developed by David Knipe, Ph.D., professor of microbiology and immunobiology at Harvard Medical School, Boston.

Preclinical testing of the candidate vaccine involved a 10-year collaborative effort between Dr. Knipe and Jeffrey Cohen, M.D., chief of NIAID’s Laboratory of Infectious Diseases.  The experimental product is a replication-defective vaccine, meaning that scientists have removed two key proteins from the vaccine virus so that it cannot multiply to cause genital herpes.

The clinical trial is expected to enroll 60 adults ages 18 to 40, who will be divided into three groups of 20 participants each. The first group will be of people who have been previously infected with HSV-2 and HSV-1 or solely with HSV-2; the second will have individuals who had been infected with HSV-1 only; and the third will consist of those who have not been  infected with HSV-1 or HSV-2. The investigational vaccine is being tested among study participants who have previously been infected with HSV to determine if it may pose any safety issues.

Within each of the three groups, researchers will randomly assign participants to receive three doses (0.5 milliliters each) of the investigational HSV529 vaccine (15 participants) or a saline-based placebo vaccine (five participants). The three vaccinations will occur at study enrollment and again one month and six months later. Participant safety will be monitored throughout the course of the trial, and researchers will follow participants for six months after they have received their last dose of vaccine. Blood samples will be used to evaluate the candidate vaccine’s ability to stimulate immune system responses to HSV-2, including production of virus-specific antibodies and T-cell responses. The study is expected to be completed by October 2016.

HSV-2 is generally transmitted through sexual contact and can spread even when the infected individual shows no symptoms. Although HSV-1 commonly infects the mouth and lips, it can also cause genital herpes. Once in the body, HSV migrates to nerve cells and remains there permanently, where it can reactivate to cause painful sores and blisters.

For more information about this clinical trial, see http://www.ClinicalTrials.gov using the identifier NCT01915212.

NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

NIH...Turning Discovery Into Health®

###

View the original article here

Agenus genital herpes vaccine succeeds in mid-stage trial

n">(Reuters) - Agenus Inc said a trial of its experimental genital herpes vaccine reduced the rate at which patients released the virus, reducing the likelihood of infecting others, sending its shares up 32 percent in premarket trading.

The 15 percent reduction in the release of the virus by patients receiving the vaccine in a mid-stage trial compared to those on a placebo, who showed no reduction.

The vaccine, HerpV, also reduced the severity of the infection by 34 percent.

The mid-stage trial had 80 patients with a history of 1-9 herpes recurrences within the prior 12 months. Of them, 70 received the vaccine and 10 received placebo, Agenus said in a statement.

HerpV, being developed as an "off-the-shelf" vaccine, contains Agenus's QS-21 Stimulon adjuvant that boosts specific immune responses.

The trial tested the efficacy of the vaccine by measuring the release of the virus by patients 45 days before and after three injections of HerpV. A majority of the patients also received a booster injection, given 6 months after the first vaccination.

Genital herpes, a highly contagious sexually transmitted infection, is usually caused by the herpes simplex virus (HSV). There are two types of HSV and Agenus's vaccine targets HSV type 2, which most often causes genital herpes.

According to the U.S. Centers for Disease Control and Prevention, 776,000 people in the United States get new herpes infections annually and one out of six people aged 14 to 49 years has genital HSV-2 infection.

Agenus said it expected more data in the first half of 2014, showing how the patients fared after the booster shots.

The company's partners are also testing the QS-21 Stimulon adjuvant in combination with other vaccines.

Agenus shares were up at $3.16 in trading before the bell. The stock closed at $2.40 on Wednesday on the Nasdaq.

(Reporting by Esha Dey in Bangalore; Editing by Saumyadeb Chakrabarty and Kirti Pandey)

Our day's top images, in-depth photo essays and offbeat slices of life. See the best of Reuters photography.  See more | Slideshow 

Thousands line up to say goodbye to Nelson Mandela, whose body is lying in state in Pretoria.  Slideshow 

Some misty views of London's famous fog.  Slideshow 

View the original article here

HerpV: Genital Herpes Vaccine Shows Promise

Nov 7 (Reuters) - Agenus Inc said a trial of its experimental genital herpes vaccine reduced the rate at which patients released the virus, reducing the likelihood of infecting others, sending its shares up 32 percent in premarket trading.

The 15 percent reduction in the release of the virus by patients receiving the vaccine in a mid-stage trial compared to those on a placebo, who showed no reduction.

The vaccine, HerpV, also reduced the severity of the infection by 34 percent.

The mid-stage trial had 80 patients with a history of 1-9 herpes recurrences within the prior 12 months. Of them, 70 received the vaccine and 10 received placebo, Agenus said in a statement.

HerpV, being developed as an "off-the-shelf" vaccine, contains Agenus's QS-21 Stimulon adjuvant that boosts specific immune responses.

The trial tested the efficacy of the vaccine by measuring the release of the virus by patients 45 days before and after three injections of HerpV. A majority of the patients also received a booster injection, given 6 months after the first vaccination.

Genital herpes, a highly contagious sexually transmitted infection, is usually caused by the herpes simplex virus (HSV). There are two types of HSV and Agenus's vaccine targets HSV type 2, which most often causes genital herpes.

According to the U.S. Centers for Disease Control and Prevention, 776,000 people in the United States get new herpes infections annually and one out of six people aged 14 to 49 years has genital HSV-2 infection.

Agenus said it expected more data in the first half of 2014, showing how the patients fared after the booster shots.

The company's partners are also testing the QS-21 Stimulon adjuvant in combination with other vaccines.

Agenus shares were up at $3.16 in trading before the bell. The stock closed at $2.40 on Wednesday on the Nasdaq. (Reporting by Esha Dey in Bangalore; Editing by Saumyadeb Chakrabarty and Kirti Pandey)

View the original article here

Chicken Pox in Children Could Lead to the Much Painful Herpes Zoster; VyGone Introduces the Ultimate Zoster Vaccine

Children that suffer from chicken pox get infected with the herpes zoster virus according to a study published on The Lawton Constitution and the virus is known to cause shingles later on in life which is credited with forming painful blisters on the body. VyGone provides the ultimate zoster vaccine on http://www.ultimatecoldsoretreatment.com/.

Boise, Idaho (PRWEB) December 26, 2012

On the 25th of November, The Lawton Constitution posted an article about the main cause of shingles, also known as the herpes zoster. The article (http://www.swoknews.com/styles-new/health) informed readers that chicken pox is to be blamed for this as it causes the herpes zoster virus to enter and settle into the body. Dr. Robert Hay was interviewed about the virus and he said, “When a child gets chickenpox and it's treated, this virus remains dormant in a nerve root,” and, “It can be anywhere in the system. We don't know what makes it come out of dormancy, but, if it does, it travels along the nerve, creating the issue known as shingles.” The article also warned those who have suffered from chicken pox to be aware of shingles so that they are not alarmed if it does in fact infect them at some point in life.

Shingles, or herpes zoster, is more commonly known as the painful blisters that form on the skin in large patches. They are caused by the herpes virus which forever remains in the body of those infected with it, even after treatment for shingles has been done. The virus may remain in its dormant state for years on end, becoming active only when any particular thing triggers the virus cells to multiply rapidly, such as weather changes, stress, weakened immunities, etc. It is found in the nerve cells of the human body. VyGone is an online based company which helps educate individuals about Shingles and has introduced an ultimate vaccine.

VyGone is the company to visit to find out about the best treatment for shingles and herpes zoster. Other than that, it also provides reliable information about not only shingles, but other various diseases and infections such as syphilis, warts, cold sores, herpes and many others. Visit the website at http://www.ultimatecoldsoretreatment.com/ to look up the zoster vaccine and other remedies. More information about the vaccine can be availed on http://www.ultimatecoldsoretreatment.com/.

Beta Marketing Group
VyGone
(801) 491-8386
Email Information

View the original article here

Doctors Advice People to Get Zoster Vaccine During Winters – VyGone Introduces Ultimate Zoster Vaccine

Winters may cause the immunities of people to lower down and this may cause people with the herpes zoster virus to develop shingles blisters. VyGone introduced Zoster vaccine to help victims fight the disease on http://www.ultimatecoldsoretreatment.com.

Boise, Idaho (PRWEB) December 24, 2012

As winter approaches fast, health and news related websites start uploading articles related to diseases and infections that people are generally prone to when temperatures fall. An article posted on the 27th of November discussed the likelihood of developing shingles during the winter season. This is because the human immune system cannot work best when it is cold all around. The article was posted on http://www.cleveland.com and mentioned famous doctors, such as Dr. Christopher Gharibo and Dr. James Campbell, who encourage people to get treatment for shingles, or the zoster vaccine, to bypass the pain caused by the virus. Dr. Gharibo was also quoted saying that people who have shingles should rest more and use cold packs to curtail the pain and that a single zoster vaccine may be enough to force the virus into its dormant state again.

Wikipedia states herpes zoster is a virus that causes shingles when it is active. This active virus causes angry red blisters to form on any particular area of the body. These form in a pattern that reflects the shape of a large, long belt and are extremely painful. The initial symptoms include a tingling sensation on the body which may later turn into a burning sensation. Other symptoms which are not that common include pain in the joints, headaches, fever, and sore genital areas. After the blisters have formed, they may remain on the body for a period of two to three weeks. After that they dry out and the skin goes back to normal in a few days. VyGone offers the Zoster vaccine which aims to eradicate the symptoms caused by Zoster and treats it for good.

Those who develop shingles may not always be certain about which treatment for shingles they should buy. Doctor appointments may leave holes in the wallets of those who cannot afford expensive medical help. For these people, companies such as VyGone have been developed. This website http://www.ultimatecoldsoretreatment.com not only provides the best treatment for shingles and zoster but also caters to the needs of those who are suffering from warts, syphilis, herpes and cold sores. More information regarding the vaccine can be availed on http://www.ultimatecoldsoretreatment.com.

Beta Marketing Group
VyGone
(801) 491-8386
Email Information

View the original article here

Progress made toward a genital herpes vaccine

ScienceDaily (Jan. 6, 2012) — An investigational vaccine protected some women against infection from one of the two types of herpes simplex viruses that cause genital herpes, according to findings in the New England Journal of Medicine.

The vaccine was partially effective at preventing herpes simplex virus type 1 (HSV-1), but did not protect women from herpes simplex virus type 2 (HSV-2). There were less than half of the cases of genital herpes caused by HSV-1 -- 58 percent fewer -- in women who received the investigational vaccine compared to women who received the control vaccine.

"There is some very good news in our findings. We were partially successful against half of the equation -- protecting women from genital disease caused by HSV-1," said Robert Belshe, M.D., director of the Saint Louis University Center for Vaccine Development and lead author of the study.

"It's a big step along the path to creating an effective vaccine that protects against genital disease caused by herpes infection. It points us in the direction to work toward making a vaccine that works on both herpes simplex viruses."

Both HSV-1 and HSV-2 are members of the herpesvirus family. Typically, HSV-2 causes lesions and blisters in the genital area. HSV-1 generally causes sores in the mouth and lips, although it increasingly has been found to cause genital disease.

There currently is no cure or approved vaccine to prevent genital herpes infection, which affects about 25 percent of women in the United States and is one of the most common communicable diseases. Once inside the body, HSV remains there permanently. The virus can cause severe neurological disease and even death in infants born to women who are infected with HSV and the virus is a risk factor for sexual transmission of HIV.

The clinical trial of an investigational genital herpes vaccine was funded by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health, along with GlaxoSmithKline (GSK), and conducted at 50 sites in the U.S. and Canada.

The study enrolled 8,323 women between ages 18 and 30 who did not have HSV-1 or HSV-2 infection at the start of the study. They were randomly assigned to receive either three doses of the investigational HSV vaccine that was developed by GSK or a hepatitis A vaccine, which was the control.

Participants were followed for 20 months and evaluated carefully for occurrence of genital herpes disease. In addition, all study participants were given blood tests to determine if asymptomatic infection with HSV-1 or HSV-2 occurred during the trial. Researchers found that two or three doses of the investigational vaccine offered significant protection against genital herpes disease caused by HSV-1. However the vaccine did not protect women from genital disease caused by HSV-2.

"We were surprised by these findings," said Belshe, who also is a professor of infectious diseases and immunology at Saint Louis University School of Medicine. "We didn't expect the herpes vaccine to protect against one type of herpes simplex virus and not another. We also found it surprising that HSV-1 was a more common cause of genital disease than was HSV-2."

HSV-1 infection has become an increasingly common cause of genital disease, likely because more couples are engaging in oral sex. HSV-1 and HSV-2 are spread by direct contact -- mouth to mouth, mouth to genitals and genitals to genitals -- even when the infected person shows no symptoms, Belshe added.

Researchers are conducting laboratory tests on serum obtained from study participants as they continue to study why the vaccine protected women from genital disease caused by HSV-1 and not HSV-2.

One hypothesis, Belshe said, is HSV-1 is more easily killed by antibodies than is HSV-2. This means that the vaccine antibodies might work better against HSV-1 and result in protection from HSV-1 but not HSV-2.

Earlier studies of the investigational herpes vaccines showed it protected against genital herpes disease in women who were not infected with HSV-1 or HSV-2, but whose sexual partners were known to have genital herpes. Researchers believe the reason for the different outcome in the most recent clinical trial could be related to the fact that different populations were studied. The women in the earlier studies may have been protected due to immunologic or behavioral factors not present in the later study.

"It's always important to confirm scientific findings in repeated studies, which is why we investigated the vaccine in a large, placebo controlled trial," Belshe said. "Our findings confirmed the validity of the scientific process. You've got to have good scientific evidence that something actually works."

Share this story on Facebook, Twitter, and Google:

Other social bookmarking and sharing tools:

Story Source:

The above story is reprinted from materials provided by Saint Louis University.

Note: Materials may be edited for content and length. For further information, please contact the source cited above.

Journal Reference:

Robert B. Belshe et al. Efficacy Results of a Trial of a Herpes Simplex Vaccine. New England Journal of Medicine, Jan 5, 2012 DOI: 10.1056/NEJMoa1103151

Note: If no author is given, the source is cited instead.

Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of ScienceDaily or its staff.

View the original article here

Shingles vaccine is safe, according to new study

ScienceDaily (Apr. 23, 2012) — The herpes zoster vaccine, also known as the shingles vaccine, is generally safe and well tolerated according to a Vaccine Safety Datalink study of 193,083 adults published online in the Journal of Internal Medicine.

More than 1 million people develop shingles every year in the United States. Shingles is a painful contagious rash caused by the dormant chickenpox virus which can reactivate and replicate, damaging the nerve system. The elderly are especially vulnerable because immunity against the virus that causes shingles declines with age.

The VSD project is a collaborative effort between the Centers for Disease Control and Prevention and integrated care organizations, including Kaiser Permanente. The VSD project monitors immunization safety and addresses the gaps in scientific knowledge about any rare and serious events that occur following immunization.

This study examined adverse events after the zoster vaccine was administered to 193,083 adults aged 50 and older from Jan. 1, 2007, to Dec. 31, 2008. Vaccination data were retrieved from electronic health records and collected from eight managed care organizations participating in the VSD project.

Researchers found a small increased risk of local reactions from one to seven days after vaccination. These findings corroborate clinical trials of the vaccine in which there was evidence of a minor local reaction at the injection site in the form of redness and pain.

The study found no increased risk for cerebrovascular diseases; cardiovascular diseases; meningitis, encephalitis, and encephalopathy; Ramsay-Hunt syndrome; or Bell's palsy.

"It's good to know there is no serious adverse reaction to the zoster vaccine. The study supports the CDC's Advisory Committee on Immunization Practices' recommendation and reassures the general public that the vaccine is safe," said study lead author Hung Fu Tseng, PhD, MPH, a research scientist with the Kaiser Permanente Southern California Department of Research & Evaluation in Pasadena, Calif.

The herpes zoster vaccine was licensed in 2006, but few people have been vaccinated, national data shows. The ACIP recommends the vaccine for healthy people age 60 years and older. In 2011, the U.S. Food and Drug Administration approved the use of the herpes zoster vaccine in individuals 50 to 59 years of age. The study results provide important safety data for people in this age group as well as adults 60 and older.

Share this story on Facebook, Twitter, and Google:

Other social bookmarking and sharing tools:

Story Source:

The above story is reprinted from materials provided by Kaiser Permanente.

Note: Materials may be edited for content and length. For further information, please contact the source cited above.

Journal Reference:

H. F. Tseng, A. Liu, L. Sy, S. M. Marcy, B. Fireman, E. Weintraub, J. Baggs, S. Weinmann, R. Baxter, J. Nordin, M. F. Daley, L. Jackson, S. J. Jacobsen. Safety of zoster vaccine in adults from a large managed-care cohort: a Vaccine Safety Datalink study. Journal of Internal Medicine, 2012; 271 (5): 510 DOI: 10.1111/j.1365-2796.2011.02474.x

Note: If no author is given, the source is cited instead.

Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of ScienceDaily or its staff.

View the original article here

Zoster vaccine associated with lower risk of shingles in older adults

ScienceDaily (Jan. 12, 2011) — Vaccination for herpes zoster, a painful rash commonly known as shingles, among a large group of older adults was associated with a reduced risk of this condition, regardless of age, race or the presence of chronic diseases, according to a study in the January 12 issue of JAMA.

"The pain of herpes zoster is often disabling and can last for months or even years, a complication termed postherpetic neuralgia. Approximately 1 million episodes of herpes zoster occur in the United States annually, but aside from age and immunosuppression, risk factors for this condition are not known," the authors write. Although prelicensure data provided evidence that herpes zoster vaccine works in a select study population under idealized circumstances, the vaccine needs to be evaluated in field conditions to show whether benefits of the vaccine can be generalized to conditions of clinical practice, according to background information in the article. The researchers note that this is particularly important for the herpes zoster vaccine, given the medical and physiological diversity in the elderly population for whom the vaccine is indicated.

Hung Fu Tseng, Ph.D., M.P.H., of Southern California Kaiser Permanente, Pasadena, Calif., and colleagues evaluated the risk of herpes zoster after receipt of herpes zoster vaccine among individuals in general practice settings. The study included community-dwelling adults, age 60 years or older, who were members of a managed care organization. There were 75,761 members in the vaccinated cohort, who were age matched (1:3) to 227,283 unvaccinated members.

Compared with the unvaccinated cohort, individuals in the vaccinated cohort were more likely to be white, women, and to have had more outpatient visits, and a lower prevalence of chronic diseases. There were 5,434 herpes zoster cases identified in the study (6.4 cases per 1,000 persons per year among vaccinated individuals and 13.0 cases per 1,000 persons per year among unvaccinated individuals). In the fully adjusted analysis, vaccination was associated with reduced risk of herpes zoster. The reduction in risk did not vary by age at vaccination, sex, race, or with presence of chronic diseases. Herpes zoster vaccine recipients had reduced risks of ophthalmic herpes zoster and hospitalizations coded as herpes zoster. Overall, the vaccine was associated with a 55 percent reduction in incidence of herpes zoster.

"Herpes zoster vaccine was licensed recently, which means the durability of its protection needs to be assessed in future studies. Meanwhile, however, this vaccine has the potential to annually prevent tens of thousands of cases of herpes zoster and postherpetic neuralgia nationally. To date, herpes zoster vaccine uptake has been poor due to weaknesses in the adult vaccine infrastructure and also due to serious barriers to the vaccine among clinicians and patients. Solutions to these challenges need to be found so that individuals seeking to receive herpes zoster vaccine will be able to reduce their risk of experiencing this serious condition," the authors conclude.

Share this story on Facebook, Twitter, and Google:

Other social bookmarking and sharing tools:

Story Source:

The above story is reprinted from materials provided by JAMA and Archives Journals.

Note: Materials may be edited for content and length. For further information, please contact the source cited above.

Journal Reference:

H. F. Tseng, N. Smith, R. Harpaz, S. R. Bialek, L. S. Sy, S. J. Jacobsen. Herpes Zoster Vaccine in Older Adults and the Risk of Subsequent Herpes Zoster Disease. JAMA: The Journal of the American Medical Association, 2011; 305 (2): 160 DOI: 10.1001/jama.2010.1983

Note: If no author is given, the source is cited instead.

Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of ScienceDaily or its staff.

View the original article here

Genital herpes vaccine ineffective in women, study suggests

ScienceDaily (Sep. 30, 2010) — An experimental vaccine intended to prevent genital herpes disease in women, although generally safe and well-tolerated, proved ineffective when tested in the recently concluded clinical study known as the Herpevac Trial for Women.

The Phase 3 trial, sponsored by GlaxoSmithKline (GSK) Biologicals, based in Belgium, with support from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, began in 2002. A total of 8,323 women aged 18-30 years participated in the trial at 50 sites in the United States and Canada. At the time of their enrollment, the study participants were free of the two types of herpes simplex viruses (HSV), HSV-1 and HSV-2.

Participants in the Herpevac trial were randomly divided into two groups. One group received the candidate vaccine, containing HSV protein along with an adjuvant intended to boost immune responses. The second, control group received a version of Havrix, a licensed vaccine against hepatitis A. This study design gave all participants the potential opportunity to be protected against either genital herpes or hepatitis A. GSK developed the candidate vaccine and also manufactures Havrix.

Each volunteer was vaccinated at the beginning of the study and again one and six months later. The participants were followed for 20 months after the initial injection and evaluated at each visit for HSV infection and genital herpes disease.

In two earlier studies involving men and women who did not have genital herpes but whose sexual partners were known to be infected, the candidate vaccine prevented genital herpes disease in more than 70 percent of the female volunteers who were free of HSV-1 and HSV-2 but had no clear effect in men. These studies formed the basis to conduct the larger Herpevac study in women only.

In the Herpevac study, however, the investigational vaccine was ineffective in protecting against genital herpes disease. The estimate of vaccine effectiveness was 20 percent, but all estimates have statistical uncertainty, and this effect was not substantially different from zero.

It is not known at this time why the vaccine proved ineffective, but the study collaborators continue to evaluate the trial data and intend to provide a more detailed analysis at a later date.

All the study investigators have been informed of the results. Study participants are being notified as to which vaccine they received, and those volunteers who received the candidate herpes vaccine are being offered Havrix.

HSV-1 and HSV-2, which cause cold sores and genital herpes disease, may be transmitted through sexual or other skin-to-skin contact, and can be spread even when the infected individual shows no symptoms. HSV can cause severe illness in infants born to HSV-infected women, and the virus has been identified as a risk factor for HIV transmission in adults. An estimated 1 in 4 women in the United States has genital herpes.

Share this story on Facebook, Twitter, and Google:

Other social bookmarking and sharing tools:

Story Source:

The above story is reprinted from materials provided by NIH/National Institute of Allergy and Infectious Diseases.

Note: Materials may be edited for content and length. For further information, please contact the source cited above.

Note: If no author is given, the source is cited instead.

Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of ScienceDaily or its staff.

View the original article here

Shingles vaccine is safe, according to new study

ScienceDaily (Apr. 23, 2012) — The herpes zoster vaccine, also known as the shingles vaccine, is generally safe and well tolerated according to a Vaccine Safety Datalink study of 193,083 adults published online in the Journal of Internal Medicine.

More than 1 million people develop shingles every year in the United States. Shingles is a painful contagious rash caused by the dormant chickenpox virus which can reactivate and replicate, damaging the nerve system. The elderly are especially vulnerable because immunity against the virus that causes shingles declines with age.

The VSD project is a collaborative effort between the Centers for Disease Control and Prevention and integrated care organizations, including Kaiser Permanente. The VSD project monitors immunization safety and addresses the gaps in scientific knowledge about any rare and serious events that occur following immunization.

This study examined adverse events after the zoster vaccine was administered to 193,083 adults aged 50 and older from Jan. 1, 2007, to Dec. 31, 2008. Vaccination data were retrieved from electronic health records and collected from eight managed care organizations participating in the VSD project.

Researchers found a small increased risk of local reactions from one to seven days after vaccination. These findings corroborate clinical trials of the vaccine in which there was evidence of a minor local reaction at the injection site in the form of redness and pain.

The study found no increased risk for cerebrovascular diseases; cardiovascular diseases; meningitis, encephalitis, and encephalopathy; Ramsay-Hunt syndrome; or Bell's palsy.

"It's good to know there is no serious adverse reaction to the zoster vaccine. The study supports the CDC's Advisory Committee on Immunization Practices' recommendation and reassures the general public that the vaccine is safe," said study lead author Hung Fu Tseng, PhD, MPH, a research scientist with the Kaiser Permanente Southern California Department of Research & Evaluation in Pasadena, Calif.

The herpes zoster vaccine was licensed in 2006, but few people have been vaccinated, national data shows. The ACIP recommends the vaccine for healthy people age 60 years and older. In 2011, the U.S. Food and Drug Administration approved the use of the herpes zoster vaccine in individuals 50 to 59 years of age. The study results provide important safety data for people in this age group as well as adults 60 and older.

Share this story on Facebook, Twitter, and Google:

Other social bookmarking and sharing tools:

Story Source:

The above story is reprinted from materials provided by Kaiser Permanente.

Note: Materials may be edited for content and length. For further information, please contact the source cited above.

Journal Reference:

H. F. Tseng, A. Liu, L. Sy, S. M. Marcy, B. Fireman, E. Weintraub, J. Baggs, S. Weinmann, R. Baxter, J. Nordin, M. F. Daley, L. Jackson, S. J. Jacobsen. Safety of zoster vaccine in adults from a large managed-care cohort: a Vaccine Safety Datalink study. Journal of Internal Medicine, 2012; 271 (5): 510 DOI: 10.1111/j.1365-2796.2011.02474.x

Note: If no author is given, the source is cited instead.

Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of ScienceDaily or its staff.

View the original article here

Genital herpes vaccine ineffective in women, study suggests

ScienceDaily (Sep. 30, 2010) — An experimental vaccine intended to prevent genital herpes disease in women, although generally safe and well-tolerated, proved ineffective when tested in the recently concluded clinical study known as the Herpevac Trial for Women.

The Phase 3 trial, sponsored by GlaxoSmithKline (GSK) Biologicals, based in Belgium, with support from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, began in 2002. A total of 8,323 women aged 18-30 years participated in the trial at 50 sites in the United States and Canada. At the time of their enrollment, the study participants were free of the two types of herpes simplex viruses (HSV), HSV-1 and HSV-2.

Participants in the Herpevac trial were randomly divided into two groups. One group received the candidate vaccine, containing HSV protein along with an adjuvant intended to boost immune responses. The second, control group received a version of Havrix, a licensed vaccine against hepatitis A. This study design gave all participants the potential opportunity to be protected against either genital herpes or hepatitis A. GSK developed the candidate vaccine and also manufactures Havrix.

Each volunteer was vaccinated at the beginning of the study and again one and six months later. The participants were followed for 20 months after the initial injection and evaluated at each visit for HSV infection and genital herpes disease.

In two earlier studies involving men and women who did not have genital herpes but whose sexual partners were known to be infected, the candidate vaccine prevented genital herpes disease in more than 70 percent of the female volunteers who were free of HSV-1 and HSV-2 but had no clear effect in men. These studies formed the basis to conduct the larger Herpevac study in women only.

In the Herpevac study, however, the investigational vaccine was ineffective in protecting against genital herpes disease. The estimate of vaccine effectiveness was 20 percent, but all estimates have statistical uncertainty, and this effect was not substantially different from zero.

It is not known at this time why the vaccine proved ineffective, but the study collaborators continue to evaluate the trial data and intend to provide a more detailed analysis at a later date.

All the study investigators have been informed of the results. Study participants are being notified as to which vaccine they received, and those volunteers who received the candidate herpes vaccine are being offered Havrix.

HSV-1 and HSV-2, which cause cold sores and genital herpes disease, may be transmitted through sexual or other skin-to-skin contact, and can be spread even when the infected individual shows no symptoms. HSV can cause severe illness in infants born to HSV-infected women, and the virus has been identified as a risk factor for HIV transmission in adults. An estimated 1 in 4 women in the United States has genital herpes.

Share this story on Facebook, Twitter, and Google:

Other social bookmarking and sharing tools:

Story Source:

The above story is reprinted from materials provided by NIH/National Institute of Allergy and Infectious Diseases.

Note: Materials may be edited for content and length. For further information, please contact the source cited above.

Note: If no author is given, the source is cited instead.

Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of ScienceDaily or its staff.

View the original article here

Progress made toward a genital herpes vaccine

ScienceDaily (Jan. 4, 2012) — An investigational vaccine protected some women against infection from one of the two types of herpes simplex viruses that cause genital herpes, according to findings in the New England Journal of Medicine.

The vaccine was partially effective at preventing herpes simplex virus type 1 (HSV-1), but did not protect women from herpes simplex virus type 2 (HSV-2). There were less than half of the cases of genital herpes caused by HSV-1 -- 58 percent fewer -- in women who received the investigational vaccine compared to women who received the control vaccine.

"There is some very good news in our findings. We were partially successful against half of the equation -- protecting women from genital disease caused by HSV-1," said Robert Belshe, M.D., director of the Saint Louis University Center for Vaccine Development and lead author of the study.

"It's a big step along the path to creating an effective vaccine that protects against genital disease caused by herpes infection. It points us in the direction to work toward making a vaccine that works on both herpes simplex viruses."

Both HSV-1 and HSV-2 are members of the herpesvirus family. Typically, HSV-2 causes lesions and blisters in the genital area. HSV-1 generally causes sores in the mouth and lips, although it increasingly has been found to cause genital disease.

There currently is no cure or approved vaccine to prevent genital herpes infection, which affects about 25 percent of women in the United States and is one of the most common communicable diseases. Once inside the body, HSV remains there permanently. The virus can cause severe neurological disease and even death in infants born to women who are infected with HSV and the virus is a risk factor for sexual transmission of HIV.

The clinical trial of an investigational genital herpes vaccine was funded by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health, along with GlaxoSmithKline (GSK), and conducted at 50 sites in the U.S. and Canada.

The study enrolled 8,323 women between ages 18 and 30 who did not have HSV-1 or HSV-2 infection at the start of the study. They were randomly assigned to receive either three doses of the investigational HSV vaccine that was developed by GSK or a hepatitis A vaccine, which was the control.

Participants were followed for 20 months and evaluated carefully for occurrence of genital herpes disease. In addition, all study participants were given blood tests to determine if asymptomatic infection with HSV-1 or HSV-2 occurred during the trial. Researchers found that two or three doses of the investigational vaccine offered significant protection against genital herpes disease caused by HSV-1. However the vaccine did not protect women from genital disease caused by HSV-2.

"We were surprised by these findings," said Belshe, who also is a professor of infectious diseases and immunology at Saint Louis University School of Medicine. "We didn't expect the herpes vaccine to protect against one type of herpes simplex virus and not another. We also found it surprising that HSV-1 was a more common cause of genital disease than was HSV-2."

HSV-1 infection has become an increasingly common cause of genital disease, likely because more couples are engaging in oral sex. HSV-1 and HSV-2 are spread by direct contact -- mouth to mouth, mouth to genitals and genitals to genitals -- even when the infected person shows no symptoms, Belshe added.

Researchers are conducting laboratory tests on serum obtained from study participants as they continue to study why the vaccine protected women from genital disease caused by HSV-1 and not HSV-2.

One hypothesis, Belshe said, is HSV-1 is more easily killed by antibodies than is HSV-2. This means that the vaccine antibodies might work better against HSV-1 and result in protection from HSV-1 but not HSV-2.

Earlier studies of the investigational herpes vaccines showed it protected against genital herpes disease in women who were not infected with HSV-1 or HSV-2, but whose sexual partners were known to have genital herpes. Researchers believe the reason for the different outcome in the most recent clinical trial could be related to the fact that different populations were studied. The women in the earlier studies may have been protected due to immunologic or behavioral factors not present in the later study.

"It's always important to confirm scientific findings in repeated studies, which is why we investigated the vaccine in a large, placebo controlled trial," Belshe said. "Our findings confirmed the validity of the scientific process. You've got to have good scientific evidence that something actually works."

Share this story on Facebook, Twitter, and Google:

Other social bookmarking and sharing tools:

Story Source:

The above story is reprinted from materials provided by Saint Louis University.

Note: Materials may be edited for content and length. For further information, please contact the source cited above.

Journal Reference:

Robert B. Belshe et al. Efficacy Results of a Trial of a Herpes Simplex Vaccine. New England Journal of Medicine, Jan 5, 2012 DOI: 10.1056/NEJMoa1103151

Note: If no author is given, the source is cited instead.

Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of ScienceDaily or its staff.

View the original article here

Zoster vaccine associated with lower risk of shingles in older adults

ScienceDaily (Jan. 11, 2011) — Vaccination for herpes zoster, a painful rash commonly known as shingles, among a large group of older adults was associated with a reduced risk of this condition, regardless of age, race or the presence of chronic diseases, according to a study in the January 12 issue of JAMA.

"The pain of herpes zoster is often disabling and can last for months or even years, a complication termed postherpetic neuralgia. Approximately 1 million episodes of herpes zoster occur in the United States annually, but aside from age and immunosuppression, risk factors for this condition are not known," the authors write. Although prelicensure data provided evidence that herpes zoster vaccine works in a select study population under idealized circumstances, the vaccine needs to be evaluated in field conditions to show whether benefits of the vaccine can be generalized to conditions of clinical practice, according to background information in the article. The researchers note that this is particularly important for the herpes zoster vaccine, given the medical and physiological diversity in the elderly population for whom the vaccine is indicated.

Hung Fu Tseng, Ph.D., M.P.H., of Southern California Kaiser Permanente, Pasadena, Calif., and colleagues evaluated the risk of herpes zoster after receipt of herpes zoster vaccine among individuals in general practice settings. The study included community-dwelling adults, age 60 years or older, who were members of a managed care organization. There were 75,761 members in the vaccinated cohort, who were age matched (1:3) to 227,283 unvaccinated members.

Compared with the unvaccinated cohort, individuals in the vaccinated cohort were more likely to be white, women, and to have had more outpatient visits, and a lower prevalence of chronic diseases. There were 5,434 herpes zoster cases identified in the study (6.4 cases per 1,000 persons per year among vaccinated individuals and 13.0 cases per 1,000 persons per year among unvaccinated individuals). In the fully adjusted analysis, vaccination was associated with reduced risk of herpes zoster. The reduction in risk did not vary by age at vaccination, sex, race, or with presence of chronic diseases. Herpes zoster vaccine recipients had reduced risks of ophthalmic herpes zoster and hospitalizations coded as herpes zoster. Overall, the vaccine was associated with a 55 percent reduction in incidence of herpes zoster.

"Herpes zoster vaccine was licensed recently, which means the durability of its protection needs to be assessed in future studies. Meanwhile, however, this vaccine has the potential to annually prevent tens of thousands of cases of herpes zoster and postherpetic neuralgia nationally. To date, herpes zoster vaccine uptake has been poor due to weaknesses in the adult vaccine infrastructure and also due to serious barriers to the vaccine among clinicians and patients. Solutions to these challenges need to be found so that individuals seeking to receive herpes zoster vaccine will be able to reduce their risk of experiencing this serious condition," the authors conclude.

Share this story on Facebook, Twitter, and Google:

Other social bookmarking and sharing tools:

Story Source:

The above story is reprinted from materials provided by JAMA and Archives Journals.

Note: Materials may be edited for content and length. For further information, please contact the source cited above.

Journal Reference:

H. F. Tseng, N. Smith, R. Harpaz, S. R. Bialek, L. S. Sy, S. J. Jacobsen. Herpes Zoster Vaccine in Older Adults and the Risk of Subsequent Herpes Zoster Disease. JAMA: The Journal of the American Medical Association, 2011; 305 (2): 160 DOI: 10.1001/jama.2010.1983

Note: If no author is given, the source is cited instead.

Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of ScienceDaily or its staff.

View the original article here

Chicken pox vaccine reduces shingles risk in kids

ScienceDaily (Dec. 4, 2009) — Herpes zoster, also known as shingles, is very rare among children who have been vaccinated against chicken pox, according to a Kaiser Permanente study in the December issue of the Pediatric Infectious Diseases Journal.

The study, the largest of its kind, used electronic health records to identify more than 170,000 children vaccinated with the varicella (chicken pox) vaccine from 2002 to 2008 in Kaiser Permanente's Southern California region, then followed children for an average of two and a half years to identify the occurrence of herpes zoster.

Researchers found only 122 cases of herpes zoster among the 172,163 vaccinated children, for an estimated incidence of 1 case per 3,700 vaccinated children per year. This is a lower rate compared to what one would expect in the unvaccinated children based on previous experiences.

"The message to parents and pediatricians is: vaccinating your child against the chicken pox is also a good way to reduce their chances of getting herpes zoster," said the study's lead author, HungFu Tseng, Ph.D, MPH, a research scientist and epidemiologist at the Kaiser Permanente Department of Research and Evaluation in Pasadena, Calif. "More research is needed to identify the virus strains that cause herpes zoster."

This study did not look at side effects of the varicella vaccine.

Herpes zoster is an acute skin viral infection caused by reactivation of latent varicella-zoster virus, which remains in certain nerve cells of the body after an infection with either wild-type or the varicella vaccine virus. The wild-type virus is found in the natural infection, in contrast to the virus strain found in vaccine.

Since the vaccine's introduction in 1995, there have been few studies on the incidence of childhood herpes zoster among children vaccinated with the varicella vaccine.

Following licensure in 1995, 1-dose varicella vaccine was recommended for children 12 months to 12 years of age. In 2006, a routine second dose of varicella vaccine for previously vaccinated persons aged 4 years and older was recommended.

Other study authors included: Ning Smith, MS, Lina S. Sy, MPH, S Michael Marcy, MD, and Steven J. Jacobsen, MD, Ph.D., from the Kaiser Permanente Department of Research and Evaluation.

Share this story on Facebook, Twitter, and Google:

Other social bookmarking and sharing tools:

Story Source:

The above story is reprinted from materials provided by Kaiser Permanente, via EurekAlert!, a service of AAAS.

Note: Materials may be edited for content and length. For further information, please contact the source cited above.

Note: If no author is given, the source is cited instead.

Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of ScienceDaily or its staff.

View the original article here

Hopeful Genital Herpes Vaccine Misses the Mark

Results Disappointing for Many, but Some See as Step Toward Success

Jan 4, 2012 -- It’s back to the drawing board for researchers seeking to develop a vaccine that protects against genital herpes.

Earlier studies of the vaccine were promising, but the new report shows that an experimental genital herpes shot was only mildly effective against herpes type 1 (HSV-1) -- which commonly causes cold sores and sometimes genital herpes -- and not effective at all against herpes type 2 (HSV-2), the most common cause of genital herpes.

Vaccine manufacturer GlaxoSmithKline provided some funding for the new study. 

Herpes virus is typically transmitted through sexual or skin-to-skin contact. It can spread even when the infected person has no symptoms. Infants born to women with herpes infections can contract herpes. HSV-1 is a growing cause of genital herpes in college students and young heterosexual women. This is why it is crucial that any vaccine protects against both HSV-1 and HSV-2.

More than 50 million adults in the U.S. have genital herpes, and up to 1.6 million new infections occur each year, according to the American Social Health Association.

The new study included more than 8,300 women ages 18 to 30 who were free of the herpes virus. Women received three doses of the new vaccine or a vaccine against hepatitis A, a virus that causes liver inflammation. Women were tracked for 20 months to see if the shot prevented herpes infection or disease.

The new vaccine was somewhat effective against HSV-1, but did not prevent infection with HSV-2, the new study showed. The findings appear in the New England Journal of Medicine.

Researchers remain puzzled about why it didn’t work well. Previous studies with more positive results were conducted among couples in which one partner was infected and the other was not. This may play a role in why the results don’t match up.

“This is not the final vaccine,” says researcher Robert B. Belshe, MD. He is a professor of medicine, pediatrics, and molecular microbiology at Saint Louis University School of Medicine in Missouri.

The new study shows that it may be possible to develop a vaccine against HSV-1 and HSV-2, he says, but the next step is to determine why it was less effective at preventing HSV-2 than HSV-1.

“This information will help us a lot,” Belshe says. “There may be a very simple answer, or it may take a more complex vaccine with many components.”

John D. Kriesel, MD, says he wouldn’t bet on this happening anytime soon. He is an infectious disease specialist at the University of Utah School of Medicine in Salt Lake City. He helped recruit women to participate in the new study.

“It is very disappointing and perplexing that it didn’t work after the two other trials showed that it did work," he says. “The reason for the failure is not entirely apparent and probably never will be.”

“The landscape for an effective herpes vaccine is bleak to say the least,” Kriesel tells WebMD.

Bruce Hirsch, MD, also thinks we are far away from an effective vaccine against genital herpes. He is an infectious disease specialist at North Shore University Hospital in Manhasset, N.Y.

“This study looked at the vaccine in a large group of women that represent the kind we most want to protect, and it didn’t seem to be effective,” he says.  

Unless and until a vaccine is proven safe and effective, antiviral medications may offer some protection against transmission. “This is reassuring,” Hirsch says.

View the original article here

Genital Herpes Vaccine - Research Progress

Editor's Choice
Academic Journal
Main Category: Sexual Health / STDs
Also Included In: Immune System / Vaccines
Article Date: 09 Jan 2012 - 7:00 PST

email to a friend   printer friendly   opinions  

A study published in the New England Journal of Medicine reveals that an investigational vaccine protected some women against infection from one of the two types of herpes simplex viruses that cause genital herpes.

Leading author Robert Belshe, M.D., director of the Saint Louis University Center for Vaccine Development commented:

"There is some very good news in our findings. We were partially successful against half of the equation - protecting women from genital disease caused by HSV-1. It's a big step along the path to creating an effective vaccine that protects against genital disease caused by herpes infection. It points us in the direction to work toward making a vaccine that works on both herpes simplex viruses."

The study findings showed that the vaccine was partially effective at preventing herpes simplex virus type 1 (HSV-1), however it did not protect women from herpes simplex virus type 2 (HSV-2). Those women who received the investigational vaccine had fewer than half (58%) the cases of genital herpes caused by HSV-1 compared with women who received the control vaccine.

HSV-1 and HSV-2 are both members of the herpes virus family. Whilst HSV-2 generally causes lesions and blisters in the genital area, the HSV-1 virus typically causes mouth and lip sores, however it has also been increasingly found to cause genital disease. At present there is no cure or approved vaccine against genital herpes infections.

Approximately 25% of females in the U.S. are HSV infected, which makes it one of the most common communicable diseases. Once a person is infected, the HSV virus stays permanently in the person's body. It can cause severe neurological disease and even cause death in infants who are born to HSV infected women. The virus is also a risk factor for sexual transmission of HIV.

The clinical trial of the investigational genital herpes vaccine was conducted at 50 sites in the U.S. and Canada and involved 8,323 women aged between18 and 30 years who had no HSV-1 or HSV-2 infection at the start of the study. The researchers randomly assigned the women to receive either three doses of the investigational HSV vaccine that was developed by GSK or a hepatitis A vaccine as control.

The participants were followed for a duration of 20 months, during which the researchers thoroughly examined the women for occurrence of genital herpes disease. All participants undertook blood tests to establish whether asymptomatic infection with HSV-1 or HSV-2 occurred during the trial.

They discovered that two or three doses of the investigational vaccine provided substantial protection against genital herpes disease caused by HSV-1, however the vaccine did not protect women from genital disease caused by HSV-2.

Belshe, who also is a professor of infectious diseases and immunology at the Saint Louis University School of Medicine declared:

"We were surprised by these findings. We didn't expect the herpes vaccine to protect against one type of herpes simplex virus and not another. We also found it surprising that HSV-1 was a more common cause of genital disease than was HSV-2."

He added that HSV-1 infection has become an increasingly common cause of genital disease, which may be due to more couples engaging in oral sex. Both HSV-1 and HSV-2 are spread by direct contact, i.e. mouth to mouth, mouth to genitals and genitals to genitals, even when the infected person shows no symptoms.

The researchers are carrying out laboratory tests on serum obtained from study participants whilst they continue to examine the reason as to why the vaccine protected women from genital disease caused by HSV-1 but not HSV-2.

Belshe said that one hypothesis is that the HSV-1 virus is more easily killed by antibodies compared with the HSV-2 virus, meaning that the vaccine antibodies might work better against HSV-1 and therefore protects from HSV-1 but not HSV-2.

Previous studies of the investigational herpes vaccines showed that the vaccine protected women against genital herpes who were not infected with HSV-1 or HSV-2, but whose sexual partners were known to have genital herpes. The researchers hypothesize that the reason for the different outcome in the most recent clinical trial could be linked to the fact that different populations were studied as women in the previous studies may have been protected due to immunologic or behavioral factors that were not present in the later study.

Belshe commented:

"It's always important to confirm scientific findings in repeated studies, which is why we investigated the vaccine in a large, placebo controlled trial. Our findings confirmed the validity of the scientific process. You've got to have good scientific evidence that something actually works."

The study was funded by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health, together with GlaxoSmithKline (GSK).

Written by Petra Rattue
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

Visit our sexual health / stds section for the latest news on this subject. Please use one of the following formats to cite this article in your essay, paper or report:

MLA

Petra Rattue. "Genital Herpes Vaccine - Research Progress." Medical News Today. MediLexicon, Intl., 9 Jan. 2012. Web.
26 Jan. 2012. APA

Please note: If no author information is provided, the source is cited instead.

posted by susangao on 9 Jan 2012 at 6:12 pm

"It's always important to confirm scientific findings in repeated studies, which is why we investigated the vaccine in a large, placebo controlled trial. Our findings confirmed the validity of the scientific process. You've got to have good scientific evidence that something actually works."

| post followup | alert a moderator |

Please note that we publish your name, but we do not publish your email address. It is only used to let you know when your message is published. We do not use it for any other purpose. Please see our privacy policy for more information.

If you write about specific medications or operations, please do not name health care professionals by name.

All opinions are moderated before being included (to stop spam)

Contact Our News Editors

For any corrections of factual information, or to contact the editors please use our feedback form.

Please send any medical news or health news press releases to:

Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms and conditions.

View the original article here

Study Dashes Herpes Vaccine Hopes

A once-promising vaccine against herpes viruses has failed in a large clinical trial, researchers reported.

The vaccine had markedly reduced the risk of genital herpes disease in women in so-called serodiscordant couples, in which one partner had the virus and other did not, according to Dr. Robert Belshe of St. Louis University in St. Louis, Mo., and colleagues.

But in a large study intended to mimic the general population of uninfected women, vaccine efficacy against disease was only 20 percent, the researchers reported in the Jan. 5 issue of the New England Journal of Medicine.

"We're really disappointed by the results," study co-author Dr. Peter Leone of the University of North Carolina in Chapel Hill told MedPage Today. But, he said, "it's the reason we do clinical trials."

Read this story on www.medpagetoday.com.

The vaccine showed some efficacy against herpes simplex-1 (HSV-1), but not against herpes simplex-2 (HSV-2), the researchers reported.

Since both viruses are common and clinically indistinguishable, Leone said, the vaccine probably would have a limited public health benefit and won't be pursued.

He said researchers probably will need to take a "different type of vaccine approach" in order to find something that works against both viruses.

In general, HSV-2 is regarded as more worrisome since it tends to recur more than HSV-1 and also is associated with an increased risk of acquiring HIV.

In the two earlier clinical trials, among discordant couples, the vaccine showed efficacy of 73 percent and 74 percent against genital disease (caused by either virus) among women who did not have antibodies against HSV-1 or HSV-2. There was no effect in men.

For this study, the researchers enrolled 8,323 women, ages 18 to 30, who did not have antibodies to either virus. They were randomly assigned to the herpes vaccine or to a hepatitis A vaccine.

The primary endpoint was occurrence of genital herpes disease due to either HSV-1 or HSV-2.

Analysis showed:

Overall, the vaccine was just 20 percent efficacious in preventing genital herpes disease

It was 58 percent efficacious against disease caused by HSV-1 but had no effect against HSV-2 disease

Overall, the vaccine protected against infection with an efficacy of 22 percent, but that was driven by a 35 percent efficacy against HSV-1 infection. There was no effect against HSV-2 infection

The researchers noted that the findings are "puzzling in view of the previous two studies involving discordant couples" -- both of which showed efficacy against HSV-2.

Leone said the difference might be a function of exposure among women in those trials, since by definition their male partners were infected with one of the two viruses.

Such exposure might have led to a cellular immune response even though it was not enough to cause the women to develop antibodies, he said.

The vaccine led to a robust antibody response against HSV-2, he noted, but those very antibodies "may have blunted any protective effect of the cellular immune response."

Interestingly, there were only two cases of HSV-1 disease in those two studies (one in each), the researchers noted, so that it was impossible to evaluate efficacy against that virus.

In other words, the overall efficacy rates of about 74 percent were based entirely on efficacy against HSV-2.

View the original article here

Trial: Herpes vaccine hopes ended

Published: Jan. 5, 2012 at 11:16 PM

ST. LOUIS, Jan. 5 (UPI) -- A herpes vaccine only protected against one type of herpes virus, and hopes have ended for now that the vaccine can prevent the disease, U.S. researchers say.

Lead author Dr. Robert Belshe, director of the Saint Louis University Center for Vaccine Development, said the vaccine was partially effective at preventing herpes simplex virus type 1, but did not protect women from herpes simplex virus type 2.

The study, published in the New England Journal of Medicine, found the experimental vaccine was 58 percent effective at preventing genital herpes from herpes simplex virus type 1, but did not show protection against herpes simplex virus type 2.

Both herpes simplex virus type 1 and herpes simplex virus type 2 are members of the herpes virus family and typically, herpes simplex virus type 2 causes lesions and blisters in the genital area.

Herpes simplex virus type 1 generally causes sores in the mouth and lips, although it increasingly has been found to cause genital disease, Belshe explained

There currently is no cure or approved vaccine to prevent genital herpes infection, which affects about 25 percent of women in the United States and is one of the most common communicable diseases and, once inside the body, remains there permanently, Belshe said.

"There is some very good news in our findings," Belshe said in a statement. "We were partially successful against half of the equation -- protecting women from genital disease caused by herpes simplex virus type 1."

View the original article here

Vaccine Fails to Protect Against Herpes Transmission

A promising shot against herpes virus misses the mark. But antiviral drugs can control infection, if only for a short time

Encouraged by the success of vaccines against human papillomavirus, researchers began developing a shot that they hoped would immunize women against another sexually transmitted virus, herpes. But the latest results, reported in the New England Journal of Medicine, aren’t encouraging.

The vaccine was designed to protect women against two forms of herpes, HSV1 and HSV2, and involved more than 8000 women between ages 18 and 30. Previous studies had shown the shot provided some protection against infection with the viruses, but the latest trial revealed that the vaccine was only mildly effective in preventing HSV-1 infections and not protective at all against HSV-2. None of the women had herpes at the start of the study, and were followed for 20 months to see if three doses of the shot prevented herpes infection due to normal sexual activity. Half of the women received the hepatitis A vaccine, which served as a control.

“I think this is the end of the vaccine,” the study’s co-author Dr. Peter Leone, an infectious disease expert at University of North Carolina Chapel Hill told msnbc.com.

MORE: How Many Patients Spread Herpes, But Don’t Even Know They Have It?

The study wasn’t a complete waste, however, since the researchers learned some new things about herpes infections that could improve future treatments. Most experts had thought that HSV-1 was primarily responsible for cold sores, while HSV-2 contributed to blisters on the genitals. The study showed, however, that women who didn’t receive the vaccine were more likely to contract genital herpes due to HSV-1.

That means that a vaccine able to protect against both HSV-1 and HSV-2 will be critical, and Leone and his team already have some ideas about how to develop one. While the current shot included snippets of herpes virus protein to alert the immune system, a more effective vaccine may need a more robust trigger, such as a weakened form of the virus, to elicit a proper virus-killing response.

In the meantime, there are drugs that can reduce the symptoms of herpes infections. In a study reported in the journal Lancet, scientists say that anti-viral drugs such as valacyclovir (Valtrex) and acyclovir (Zovirax) can lower the amount of HSV-2 virus shed in the body during infection. The effect isn’t long lasting, but can help in lowering risk of transmission. That’s why a vaccine is so important to truly control spread of the virus. According to the Centers for Disease Control, 16% of Americans between 14 and 49 are infected with HSV-2.

View the original article here

Experimental herpes vaccine disappoints in study

By Ryan Jaslow Topics News ,Women ,Disease ,Research (Credit: istockphoto)

(CBS) An experimental herpes vaccine failed to protect young women from the disease in a new study, dashing hopes that a vaccine may soon be available to help prevent the sexually transmitted disease.

PICTURES: Bogus STD cures: Are you taking one?

In a study of 8,300 women ages 18 to 30, the vaccine, developed by GlaxoSmithKline, partially protected against HSV-1, the strain of herpes which typically causes cold sores but can also cause genital herpes. The vaccine, however, did not protect against HSV-2, the strain that most commonly causes genital herpes.

"There is some very good news in our findings. We were partially successful against half of the equation - protecting women from genital disease caused by HSV-1," study author Dr. Robert Belshe, director of the Saint Louis University Center for Vaccine Development, said in a written statement.

None of the women had any strain of herpes when the study began, and half of the women were given the experimental vaccine while the other half were given a hepatitis A vaccine. Doctors monitored the women for twenty months, and throughout the study, some women got herpes.  The experimental vaccine was 58 percent effective at preventing genital herpes from HSV-1, but did not show protection against HSV-2. The study was published in the Jan. 5 issue of the New England Journal of Medicine.

Belshe said in the statement he was surprised the vaccine protected against one type of vaccine and not the other, but thinks that finding could lead to more research to better understand the disease.

"This is not the final vaccine," Belshe told WebMD. "This information will help us a lot."

Some experts aren't as optimistic.

"I was very disappointed there wasn't more of a benefit," Dr. Bruce Hirsch, an attending physician in infectious diseases at North Shore University Hospital in Manhasset, N.Y., who wasn't involved in the study, told HealthDay. "I'm concerned if we'll ever find a vaccine effective for HSV-2."

"Enough vaccines have failed that companies are seeing herpes vaccines as a risky business," added Dr. David Knipe, a virologist at Harvard Medical School in Boston. Knipe told Nature News he thinks the public sector might need to fund herpes vaccine research to further advance it.

More than 50 million U.S. adults have herpes, according to WebMD, with up to 1.6 new infections occurring each year. Abstinence is the only way to prevent the STD, and latex condoms can reduce the risk of transmission, but the disease still can spread with condom use. The CDC says persons with herpes should abstain from sexual activity with uninfected partners when lesions or other symptoms are present. But even without symptoms, herpes can still spread to a partner.

The CDC has more on genital herpes.

Comment reply The posting of advertisements, profanity, or personal attacks is prohibited. By using this Web site you agree to accept our Terms of Service. Click here to read the Rules of Engagement. Latest CBS News Headlines Popular CBS News Stories
on Facebook Most Discussed Stories
on CBS News Better Information. Better Health.

View the original article here