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.

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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."

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New Treatment Available for Painful and Embarrassing Genital Herpes Symptoms Through the Use of Electro Waveform ...

VyGone Inhibitor Zapper brings quick relief to thousands suffering from genital herpes, genital warts, shingles, cold sores, herpes and other uncomfortable and embarrassing conditions before they ever appear

Springville, UT (PRWEB) January 24, 2012

More than 60 million people in the US suffer from genital herpes, according to the US Department of Health and Human Services. If you are one of them, you probably already know there is no way to cure herpes.

Genital herpes are caused by herpes viruses that are transmitted through skin to skin contact with somebody already infected with the virus. Many people don’t realize they have become infected until the symptoms start to appear a few days after the exposure. The viruses – which are like a short DNA protein and are 100,000 times smaller than a cell -- are not alive. Therefore, they can never be killed.

But now there is a new, pain-free way to eliminate the symptoms caused by the genital herpes virus. The VyGone Inhibitor Zapper harnesses the power of electro waveform technology for the treatment of herpes, as well as genital warts, shingles and other conditions caused by microscopic viruses. When applied to infected areas, the mild electro waveform released by the VyGone Zapper stops viral activities and allows fast natural healing, eliminating ugly and embarrassing genital herpes symptoms.

Genital Herpes Simplex-II viruses cause recurring blisters and lesions similar to cold sores, but in the genital area. This is a very personal problem, causing emotional distress.

One out of every four people in this country, aged 9 an older, suffer from genital herpes, with the virus most common in women and black males.

Within 2 to 10 days after infection, symptoms such as painful itching and burning in genital area, then small red bumps begin to appear. Pain may occur in legs, buttocks, genital area, and when urinating. Many report blisters, painful open lesions, vaginal discharge, pressure and discomfort around the stomach, flu symptoms, fever, headache, muscle aches, and swollen glands.

There is no cure for herpes. However, early application of the Viral Inhibitor Pro at first symptoms helps to prevent lesions. Sores heal naturally faster.

To use VyGone, simply place the two prongs on your skin and press the buttons on the side of the zapper. A light will come on that indicates that the device is working properly. The first light will stay on for about ten seconds. A second light will then come on, which indicates that the zapper has reversed the direction of the electrical flow.

To eliminate genital herpes symptoms, simply apply the Viral Inhibitor Pro up to 8 times daily to each papule. To prevent lesions, users emphasize early detection and immediate applications.

The VyGone Zapper Pro is good for thousands and thousands of treatments.

VyGone also can be used for the symptoms of viruses caused by shingles, moles, genital warts and other conditions.

The VyGone Zapper is also effective for people who are prone to cold sores. They normally feel an initial tingling before the signature blister appears. Once they erupt, embarrassing, humiliating cold sores form in and around the mouth often stay visible for throughout their 7 to 14 day cycle.

But just a few applications of the VyGone Zapper stimulate neural signals that stop blisters and lesions from appearing. This electrical device provides a safe, noninvasive remedy which allows the body’s fast healing immune system to quickly suppress cold sores until their next eruption.

For Aaron, a cold sore sufferer from Wyoming, the healing effects of the VyGone Zapper were all in the family.

“My cousin told me about this Zapper and how well it works so I bought one,” Aaron said. “I get lots of cold sores so it wasn’t too long until I got one and had a chance to use it. I felt it coming on and zapped it a couple of times in its earliest stages. The burning stopped immediately and the cold sore never broke the skin. The best part is I can use this zapper for years instead of one treatment like the medication I used to use.”

The VyGone Zapper mainly targets Herpes viruses associated with genital herpes, molluscum, cold sores (oral Herpes), and shingles. It can be applied to warts, moles and other growths caused by Herpes. The Zapper is harmless, non-invasive, non-chemical, non-addictive and has no side-effects. Handheld and portable, the Zapper is private and close at hand for an attack. Over time, with consistent use, viral attacks lessen in frequency, severity and duration.

People with genital herpes now have a new weapon in their arsenal to stop herpes with the VyGone Zapper. For more information about the electro waveform technology used by the VyGone Zapper, visit our website at http://www.VyGone.com.

###

Kelsie Green
VyGone Zapper
208-323-9451 7102
Email Information

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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.

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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.

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Herpes Drugs Don't Stop Herpes Spread

Got Genital Herpes? You're Still Infectious, Even if Drugs Cut Symptoms

By Daniel J. DeNoon
WebMD Health News

Reviewed by Laura J. Martin, MD

Jan. 5, 2012 -- People with genital herpes can still infect their sex partners -- even if they are taking anti-herpes drugs that prevent herpes outbreaks.

Even when they don't have an active herpes outbreak, people who carry genital herpes viruses are at risk of infecting their sex partners. With the discovery of drugs that prevent herpes outbreaks, there was hope that the drugs would also prevent herpes transmission. But there's been troubling evidence that this may not be true.

Now University of Washington researcher Christine Johnston, MD, and colleagues show that people with no herpes symptoms often shed infectious genital herpes virus -- even while taking very high doses of anti-herpes drugs.

"Short episodes of genital [herpes virus] shedding occur frequently with antiviral therapy, even for high-dose regimens," Johnston and colleagues report. "These breakthrough episodes are typically [without symptoms], last several hours, and occur at much the same rate irrespective of antiviral dose."

One in 5 Americans and Europeans carries HSV-2, the virus that causes most cases of genital herpes; HSV-1 causes some cases. Most people have few, if any, of genital herpes' painful symptoms: blisters on or around the genitals or rectum.

There's no cure for herpes infections. That's because herpes viruses travel up nerves to take up latent form in the nerve root. Powerful anti-herpes drugs -- acyclovir (Zovirax), famciclovir (Famvir), and valacyclovir (Valtrex) -- prevent most outbreaks in most people. But they don't eliminate virus hiding in nerve cells.

Recent clinical trials failed to show that herpes drugs could prevent herpes transmission. This led Johnston's team to conduct three intensive new studies.

In each study, adult volunteers already infected with HSV-2 swabbed their genital and rectal areas four times each day for eight to 14 weeks. The swabs were tested for HSV-2.

In the first study, the volunteers were randomly given a standard 400 mg, twice-daily dose of acyclovir or an inactive placebo pill for four weeks. After a one-week washout period, they switched to the active or placebo treatment for another four weeks.

The result: Swabs were 95% less likely to test positive for HSV-2 when a person was taking acyclovir. But even during treatment, people tested positive 3% of the time.

In the second and third studies, the researchers selected volunteers who suffered frequent genital herpes outbreaks. In study two, they took either 800 mg three-a-day, high-dose acyclovir or standard 500 mg daily doses of valacyclovir. Study three compared standard-dose valacyclovir against high-dose valacyclovir (1,000 mg three times daily). As in the first study, volunteers switched treatments after a one-week washout period.

The result: None of these very high doses of active anti-herpes drugs completely prevented genital shedding of infectious herpes virus. Even with high-dose valacyclovir, 3% of swabs carried herpes virus -- and patients tested positive 7% of the time.

The findings show that herpes hiding in nerve roots doesn't sleep between outbreaks. Instead, it's frequently seeping out.

"The finding that treatment cannot fully prevent transmission should encourage patients to use condoms and adopt safe-sex practices," Philippe Van de Perre and Nicolas Nagot of the University Hospital of Montpellier, France, suggest in an editorial accompanying the Johnston report in the Jan. 5 online issue of The Lancet.

SOURCES: Johnston, C. The Lancet, published online, Jan. 5, 2012.Van de Perre, P. and Nagot, N. The Lancet, published online, Jan. 5, 2012.CDC web site.

©2012 WebMD, LLC. All Rights Reserved.

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Potential Herpes Vaccine Disappoints Researchers

WEDNESDAY, Jan. 4 (HealthDay News) -- A potential vaccine for genital herpes has shown only limited effectiveness in thwarting one type of the sexually transmitted virus and no ability to stop a second type from spreading, a new study shows.

A group of American and Canadian researchers conducted a randomized trial on more than 8,300 women aged 18 to 30 who tested negative for both forms of the herpes simplex virus, known as HSV-1 and HSV-2. Half of the women were given the experimental vaccine while the other half were given the hepatitis A vaccine.

The experimental vaccine was 58 percent effective at preventing genital disease stemming from HSV-1, but completely ineffective against HSV-2.

"We were disappointed it did not meet the primary [goal], which was protection against all types of genital herpes," said study author Dr. Robert B. Belshe, a professor of medicine, pediatrics and molecular microbiology at Saint Louis University. "Herpes is a complex organism and has ways of escaping the immune system, so we have to figure out a way of overcoming those mechanisms."

The study is published Jan. 5 in the New England Journal of Medicine.

Genital herpes affects about 16 percent of Americans aged 14 to 49, according to the U.S. Centers for Disease Control and Prevention. Both types of the virus are released from their resulting sores but can also be transmitted between outbreaks, and the infection is potentially fatal in newborns who acquire it from their mothers during birth.

Fifty clinical sites in both the United States and Canada followed the women -- who reported their own sexual risk behaviors -- between 2003 and 2007. A heightened risk for HSV-1 infection was associated with six or more lifetime sexual partners and more than one partner in the previous 12 months, while those who were 23 or older were less likely to contract HSV-1 than those between 18 and 22.

Factors not associated with an increased likelihood of HSV-1 included race, condom use, oral sex, a history of any sexually transmitted infection or ever having a partner with herpes. Men weren't tested in this study, though prior research showed investigational herpes vaccines to be ineffective in men and HSV-1 positive women.

"I was very disappointed there wasn't more of a benefit," said 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. "I think we're asking that a vaccine provide better immunity than an actual infection provides. I'm concerned if we'll ever find a vaccine effective for HSV-2."

"I think what we tell patients is ... there are antiviral medications that can make a difference and can give people comfort, and the availability of treatment is encouraging," he added.

While other potential vaccines are in the pipeline, Belshe said, the one that works probably needs to be "more complex" than the one recently studied, which contained a single surface protein of the herpes virus. The chicken pox vaccine, which has been widely used in the past decade, is a good example of a herpes-related virus that has been brought under control, he said.

"Something like that is what we need to come up with for HSV," he said. "I think this is a very important study, and the result is an incredibly important step in figuring out what will work."

More information

The U.S. Centers for Disease Control and Prevention has more on genital herpes.

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