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Trial confirms lack of efficacy for GSK’s herpes vaccine Simplirix

Pharma company halted development of the vaccine in 2010 on the back of initial results from the trial

GlaxoSmithKline's (GSK) herpes vaccine Simplirix has failed to show any efficacy against herpes simplex virus type 2 (HSV-2) as a cause of genital herpes disease.

Results of the trial, published in the New England Journal of Medicine, validate GSK's decision to halt development of the vaccine in 2010 after initial results from the phase III trial disappointed.

The company told PMLiVE: “The final trial results published in the New England Journal of Medicine reveal that the vaccine had an acceptable safety profile but the primary trial endpoint, prevention of genital herpes disease, was not met. GSK therefore made the decision not to pursue further development of Simplirix.

“GSK, NIH [US National Institutes of Health] and academic investigators are conducting additional studies to gain a more complete understanding of the results. These further tests may shed light on what is required to design an effective vaccine to prevent genital HSV disease."

The study involved 8,323 women aged 18 to 30, testing vaccine doses at zero, one and six months, and had a primary endpoint focused on the occurrence of genital herpes disease due to either herpes simplex virus type-1 (HSV-1) or HSV-2 from one month after the second dose to 19 months.

Although researchers did find the vaccine had 58 per cent efficacy against genital disease from herpes simplex virus type-1, they noted that 'efficacy against HSV-2 infection was not observed'.

The study results are especially disappointing considering the success of earlier trials of the herpes vaccine.

Two previous studies demonstrated 73 per cent and 74 per cent efficacy against genital disease in women who were negative for both HSV-1 and HSV-2 antibodies.

Speaking to MSNBC study co-author Dr Peter Leone, an infectious disease specialist at the University of North Carolina, said: “I think this is the end of the vaccine. It would be difficult to imagine marketing a vaccine that would only work against HSV-1.”

9th January 2012

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