A Randomized, Double-Blinded, Placebo-Controlled, Phase 1 Study of a Replication-Defective Herpes Simplex Virus (HSV) Type 2 Vaccine, HSV529, in Adults With or Without HSV Infection.

ABSTRACT:

Background

Herpes simplex virus 2 (HSV2) causes genital herpes in >400 million persons worldwide.

Methods

We conducted a randomized, double-blinded, placebo-controlled trial of a replication-defective HSV2 vaccine, HSV529. Twenty adults were enrolled in each of 3 serogroups of individuals: those negative for both HSV1 and HSV2 (HSV1-/HSV2-), those positive or negative for HSV1 and positive for HSV2 (HSV1±/HSV2+), and those positive for HSV1 and negative for HSV2 (HSV1+/HSV2-). Sixty participants received vaccine or placebo at 0, 1, and 6 months. The primary end point was the frequency of solicited local and systemic reactions to vaccination.

Results

Eighty-nine percent of vaccinees experienced mild-to-moderate solicited injection site reactions, compared with 47% of p

SUBMITTER: Dropulic LK 

PROVIDER: S-EPMC6688060 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature