Immunotherapy
of recurrent genital herpes with recombinant herpes simplex virus type
2 glycoproteins D and B: results of a placebo-controlled vaccine trial
Straus SE, Wald A, Kost RG, McKenzie R,
Langenberg AGM, Hohman P, Lekstrom J, Cox E, Nakamura M, Sekulovich
R, Izu A, Dekker C, Corey L.
Abstract:
To determine the safety, immunogenicity,
and efficacy of a recombinant herpes simplex virus type 2 glycoprotein
D and B vaccine in the treatment of recurrent genital herpes, a randomized,
placebo-controlled trial was held at two referral centers. Healthy patients
with 4-14 recurrences per year received injections of both glycoproteins
in MF59 adjuvant or of MF59 alone at 0, 2, 12, and 14 months. For 18
study months, the rate and number of recurrences, the duration and severity
of the first confirmed recurrence, vaccine immunogenicity, and rates
of local and systemic reactions were determined. The monthly rate of
recurrence was not significantly improved, but the duration and severity
of the first study outbreak was reduced significantly by vaccination.
Glycoprotein-specific and neutralizing antibodies were boosted by vaccination
for the duration of the study. This vaccine is safe and immunogenic
and ameliorated an observed first postvaccination genital recurrence,
but it does not reduce recurrence frequency.