Herpes simplex virus type 2 (HSV-2) is a major cause of genital herpes.

It can also cause serious infections in newborns and in people with weakened immune systems. It increases the risk of getting an HIV infection and of spreading HIV to someone else.

Therefore, a vaccine that could prevent genital herpes could improve the general health of the world s population. Researchers want to study whether a new vaccine, HSV529, which may be used in the future to prevent herpes infections, is safe.

Objectives:

- To test whether a new herpes vaccine is safe.

Eligibility:

- 69 Healthy adults 18 40 years old.

Design:

Participants will have 3 vaccination visits, 7 follow-up visits, and 3 follow-up phone calls over 1 year. Each vaccination visit will last about 4 hours. Participants will be screened with a medical history and physical exam. Participants will have a blood sample taken. Participants will be given the vaccine or a placebo, by injection from a needle. They will be monitored for 30 minutes to check for any allergic reaction. Participants will be given a diary card to record any symptoms they may feel later. At follow-up visits, participants will give a blood sample and answer health questions. In the phone calls, participants will answer health questions.

Results

On September 15, 2019, The Journal of Infectious Diseases reported results of this study.

Eighty-nine percent of vaccinees experienced mild-to-moderate solicited injection site reactions, compared with 47% of placebo recipients (95% confidence interval [CI], 12.9%–67.6%; P = .006). Sixty-four percent of vaccinees experienced systemic reactions, compared with 53% of placebo recipients (95% CI, −17.9% to 40.2%; P = .44). Seventy-eight percent of HSV1−/HSV2− vaccine recipients had a ≥4-fold increase in neutralizing antibody titer after 3 doses of vaccine, whereas none of the participants in the other serogroups had such responses. HSV2-specific CD4+ T-cell responses were detected in 36%, 46%, and 27% of HSV1−/HSV2−, HSV1±/HSV2+, and HSV1+/HSV2− participants, respectively, 1 month after the third dose of vaccine, and CD8+ T-cell responses were detected in 14%, 8%, and 18% of participants, respectively.

HSV529 vaccine was safe and elicited neutralizing antibody and modest CD4+ T-cell responses in HSV-seronegative vaccinees.