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Herpes Vaccine Still Elusive

Genital herpes is the most prevalent sexually transmitted disease in the U.S.: It is estimated that more than 20 percent of adult Americans carry herpes simplex virus type 2 (HSV-2). Despite the clear public health need for a vaccine, a major candidate now has been proved ineffective.

Two large parallel trials randomized 2,268 adults at high risk for acquiring genital herpes (515 had infected sexual partners; 1,753 had other sexually transmitted diseases) to a three-stage vaccination or to three placebo injections. The vaccine contained two recombinant HSV-2 glycoproteins that had elicited neutralizing antibodies to the virus in previous studies.

After 18 months of follow-up, rates of new HSV-2 infections were similar in the vaccination and placebo groups (4.2 percent and 4.6 percent, respectively, by intent-to-treat analysis). The vaccine did appear to slow the rate of new HSV-2 infections slightly at the beginning of the study period, but this effect disappeared after 6 months.

Comment: Despite many years of promising groundwork on this vaccine, it failed the acid test of a phase 3 clinical trial. The authors and an editorialist marvel at the complexity of antiviral immunity and this clear evidence that neutralizing antibodies alone will not protect against HSV-2 in the clinical setting.

— A Zuger

Published in Journal Watch General Medicine August 17, 1999

Citation(s):

Corey L et al. Recombinant glycoprotein vaccine for the prevention of genital HSV-2 infection. JAMA 1999 Jul 28 282 331-340.

Mascola JR. Herpes simplex virus vaccines -- why don't antibodies protect?. JAMA 1999 Jul 28 282 379-380.

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