GSK drops herpes vaccine
pharmafile | October 4, 2010 | News story | Research and Development, Sales and Marketing | GlaxoSmithKline, Simplirix, herpes, sexual health
Poor phase III results have forced GlaxoSmithKline to halt development of its Simplirix vaccine for women with genital herpes.
The phase III Herpevac Trial for Women showed that although the vaccine had an acceptable safety profile, it failed to prevent the disease in women, its primary endpoint.
The study was conducted collaboratively between GSK and the US National Institute of Allergy and Infectious Diseases (NIAID), a part of the US National Institutes of Health (NIH).
NIAID said in a statement that the estimate of vaccine effectiveness was 20%, but all “estimates have statistical uncertainty, and this effect was not substantially different from zero”.
It is not currently known why the vaccine proved ineffective, but the study collaborators have said they will continue to evaluate the trial data and intend to provide a more detailed analysis at a later date.
Gary Dubin, VP and director of late clinical development at GSK biologicals, said: “We would like to express our gratitude towards our partner NIAID for their proactive collaboration and substantial contribution in the programme and the volunteers for their participation in the study.”
The trial began in 2002 and involved some 8,300 women ages 18-30 being vaccinated at 50 study sites across North America.
In two earlier studies involving both men and women, who did not have genital herpes but whose sexual partners were known to be infected, the candidate vaccine prevented genital herpes in more than 70% of the female volunteers who were free of HSV-1 and HSV-2, but had no clear effect in men.
GSK and NIH said they will continue to evaluate data from the latest trial and plan to present details of the analysis “in the near future in an appropriate scientific forum”.
Ben Adams
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