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101028 tn?1419606604

herpevax vaccine failed :(


WASHINGTON (Reuters) – GlaxoSmithKline  said on Thursday that it was stopping development of a genital herpes vaccine after it failed to protect women against the virus.

The U.S. National Institutes of Health said the test of 8,000 women in the United States and Canada showed the Simplirix vaccine failed to protect them significantly from genital herpes.

"The estimate of vaccine effectiveness was 20 percent, but all estimates have statistical uncertainty, and this effect was not substantially different from zero," the National Institute of Allergy and Infectious Diseases, an NIH institute, said in a statement.

The Phase III trial, the last step before regulatory approval of a drug or vaccine, was sponsored by Glaxo at 50 sites in the United States and Canada.

"GlaxoSmithKline has made the decision not to pursue further worldwide development of Simplirix," the company said in a statement.

The women, aged 18 to 30, all started out free of infection by either the herpes simplex 1 virus that causes cold sores or the related HSV-2, which causes genital herpes.

The researchers sponsored by the NIAID followed the women for nearly two years to see if they became infected with either virus in their day-to-day lives.

It had been a difficult trial to put together because both viruses are very common.

Between 50 percent and 80 percent of Americans are infected with HSV-1, which usually causes cold sores. Up to 20 percent of those over 12 are infected with HSV-2, and more than 1 million new cases of genital herpes are diagnosed in the United States each year.

Genital herpes is sexually transmitted and can not only cause painful and debilitating outbreaks of blisters, but it can also kill newborns if passed on by the mother in childbirth.

The 8,000 volunteers had been divided into two groups. Half got the vaccine against herpes, which included an immune system booster called an adjuvant.

The other half got Glaxo's hepatitis A vaccine instead.

Earlier studies had shown the herpes vaccine protected 70 percent of women whose sex partners were infected with the virus.

It did not protect men at the time -- something that puzzled the researchers -- and the NIH said it did not know why the vaccine did not work this time in women, either.

More details are available at http://www.niaid.nih.gov/news/newsreleases/2010/Pages/Herpevac.aspx.

Vaccine experts estimate it can take up to $1 billion to develop a new vaccine. Some are easy -- the first smallpox vaccine was invented in 1796.

But others are far more difficult, and viruses such as herpes and HIV, which take up permanent residence in the body, have proved impossible to eradicate or vaccinate against.

Researchers are also struggling to make vaccines against the malaria parasite.

7 Responses
Avatar universal
This is sad but I still am hopeful for a cure and a vaccine.  I mean, we have bionic eyes now for people who lost their sight.  I never thought that would be possible but I was proven wrong.  I'm sure there will be a cure for not only HSV 1 and 2 but for other diseases as well.  :)
Avatar universal
What the heck happened???  How did it go from 70% percent effectiveness to an uncertain 20%??

101028 tn?1419606604
each time they increased the group size for testing the effectiveness got smaller. phase 2 trials were 40%. over 5000 participants in the phase 3 and the result was 20% effectiveness.  

Avatar universal

I don't understand why we aren't further advanced medically than we are now.  Remember when they predicted in 2010 we'd have flying cars?  We can't even cure something 1 out 4-5 people have!!!  

Yes, viruses are complex........but I'm still hopeful, though.  
101028 tn?1419606604
we haven't even cured the common cold yet let alone any other virus. viruses constantly mutate and it's not as easy to cure.

bill halford's vaccine is in development, hopefully it gets funding and approval for human trials. it looks far more promising than the herpevac did.
Avatar universal
The prospect of a live virus in a vaccine scares the crap out of me!!!!  But it makes sense.
101028 tn?1419606604
I'm sure over the next few months there will be very interesting and informative info that comes out from this study. as new things are published, I''ll be sure to journal about them if they are interesting.
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