Study finds genital herpes vaccine ineffective in women

September 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 (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 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 , 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 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 .

More information: www.niaid.nih.gov/news/QA/pages/HerpevacQA.aspx

Related Stories

Recommended for you

With no morphine, 25 million die in pain each year: report

October 13, 2017
Every year, some 25 million people—one in ten of them children—die in serious pain that could have been alleviated with morphine at just a few cents per dose, researchers said Friday.

Study finds few restrictions on Rx opioids through Medicare

October 9, 2017
Medicare plans place few restrictions on the coverage of prescription opioids, despite federal guidelines recommending such restrictions, a new Yale study finds. The research results highlight an untapped opportunity for ...

Nocebo effect: Does a drug's high price tag cause its own side effects?

October 5, 2017
Pricey drugs may make people more vulnerable to perceiving side effects, a new study suggests—and the phenomenon is not just "in their heads."

Pre-packaged brand version of compounded medication to prevent preterm births costs 5,000 percent more

October 2, 2017
Preventing a preterm birth could cost as little as $200 or as much as $20,000, depending on which one of two medications a doctor orders, according to a new analysis from Harvard Medical School.

Cancer drugs' high prices not justified by cost of development, study contends

September 12, 2017
(HealthDay)— Excusing the sky-high price tags of many new cancer treatments, pharmaceutical companies often blame high research and development (R&D) costs.

Non-psychotropic cannabinoids show promise for pain relief

September 4, 2017
Some cancers love bone. They thrive in its nutrient-rich environment while gnawing away at the very substrate that sustains them, all the while releasing inflammatory substances that cause pain—pain so severe that opioids ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.