GlaxoSmythKline recently conducted safety trial studies on their new experimental Genital Herpes vaccine ‘Simplirix’. 8,323 women aged 18-30 years participated in the trial at 50 sites in the US & Canada. Based on the results the product has failed miserably. The question is why were these women infected with Herpes after vaccination with the virus? If they weren’t sexually active at the time or involved with partners already infected a class action Lawsuit against GSK should logically ensue.

“The estimate of vaccine effectiveness was 20 percent, but all estimates have statistical uncertainty, and this effect was not substantially different from zero.” National Institute of Health

NATIONAL INSTITUTES OF HEALTH STATEMENT
Study Finds Genital Herpes Vaccine Ineffective in Women –

‘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 + 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; 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.’

GSK PRESS RELEASE: 09/30/10 GlaxoSmithKline (GSK) has made the decision not to pursue further worldwide development of Simplirix™ (Herpes Simplex Vaccine), an experimental vaccine intended to prevent genital herpes disease in women. The decision was made following receipt of the results of the Herpevac Trial for Women, a Phase III trial evaluating efficacy of Simplirix™, which was conducted collaboratively with the US National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH).

The trial began in 2002 and 8,323 women ages 18-30 were vaccinated at 50 sites in the United States and Canada.  An assessment of the final trial results showed that the vaccine had an acceptable safety profile, but the primary trial endpoint, prevention of genital herpes disease, was not met. GSK and NIH continue to evaluate data from the trial and plan to present details of the analysis in the near future in an appropriate scientific forum.

Gary Dubin, Vice President and Director, Late Clinical Development at GlaxoSmithKline Biologicals commented: “We would like to express our gratitude towards our partner NIAID for their proactive collaboration and substantial contribution in the program and the volunteers for their participation in the study.”
http://www.gsk.com/media/pressreleases/2010/2010_pressrelease_10105.htm

http://www.niaid.nih.gov/news/newsreleases/2010/Pages/Herpevac.aspx
http://topnews.co.uk/214026-herpes-vaccination-gsk-fails-trial

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