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Investigational herpes vaccine ineffective in women
Belshe RB. N Engl J Med. 2012;366:34-43.
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New findings published today in The New England Journal of Medicine indicate that the investigational recombinant glycoprotein D-based herpes simplex virus type 2 vaccine was not effective against herpes simplex virus type 2 and was only 38% efficacious against herpes simplex virus type 1 in women.
“It was a surprise that it protected against herpes simplex virus type 1 (HSV-1), but not HSV-2,” Robert B. Belshe, MD, of the division of infectious diseases, allergy and immunology at Saint Louis University School of Medicine, told Infectious Disease News. “The other interesting thing we observed is that the epidemiology of herpes is changing and that there is more genital disease caused by HSV-1 than HSV-2.”
Belshe and researchers conducted a double blind field trial and aimed to assess the efficacy of the subunit vaccine against all types of genital herpes in 8,323 HSV-1 and HSV-2 seronegative women aged 18 to 30 years.
Women were randomly assigned to receive the investigational vaccine (20 mcg of glycoprotein D from HSV-2 with alum and 3-O-deacylated monophosphoryl lipid A) or to the hepatitis A vaccine (controls) at baseline and at months 1 and 6.
At 20 months, researchers found that vaccine efficacy was 58% (95% CI, 12-80) against HSV-1 genital disease and 35% (95% CI, 13-52) against HSV-1 infection. However, the vaccine was not effective against HSV-2 infection (–8%; 95% CI, -59 to 26).
“We need to change our direction while working with herpes vaccines to move from subunits, such as the one we tested to a live-attenuated virus,” Belshe said. “There are several herpes viruses; chicken pox, for example, is a herpes virus. The only vaccine we have against any of the herpes viruses is a chicken pox vaccine, which is a live-attenuated virus. Live-attenuated vaccines are the way to go for preventing herpes viruses.”
Disclosure: This research was funded by the National Institute of Allergy and Infectious Diseases and GlaxoSmithKline; ClinicalTrials.gov number, NCT00057330.
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