Study of the Safety of a Particular Herpes Vaccine in Adults With or Without Herpes Infection

Healthy Volunteers Clinical Trial

Official title: Phase I Study of the Safety of a Replication-Defective Herpes Simplex Virus-2 Vaccine, HSV529, in Adults Aged 18 to 40 Years With or Without HSV Infection

Status Completed

Clinical Trial Summary

Background:

• Herpes simplex virus type 2 (HSV-2) is a major cause of genital herpes. It can also cause serious infection 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:

• 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.

Clinical Trial Description

Herpes simplex virus 2 (HSV-2) causes genital herpes and increases the risk of acquisition and transmission of HIV. An HSV-2 vaccine is not available. We will study a replication-defective HSV-2 vaccine, HSV529, that is deleted for 2 essential viral proteins, that can infect, but not replicate in normal cells. The goals of the study are to determine (a) the safety of HSV529 vaccine in persons with or without HSV infection, and (b) the ability of the vaccine to elicit immune responses to HSV-2 including virus-specific antibodies and T cell responses to the virus. Three groups of 20 subjects each will be randomized and will receive 3 doses of HSV529 (15 subjects per group) or saline placebo injection (5 subjects per group). Each subject will be followed for 6 months after the last dose of vaccine. The 3 groups will be (a) subjects who were infected with HSV-2 in the past but may or may not have been infected with HSV-1 (HSV-1+/-/HSV-2+), (b) subjects who have been infected only with HSV-1 (HSV-1+/HSV-2-), and (c) subjects who have not been infected with HSV-1 or HSV-2 (HSV-1-/HSV-2-). Vaccine or placebo will be administered on Day 0 and approximately 1 month and 6 months after enrollment. ;

Related Conditions & MeSH terms

• Healthy Volunteers
• Herpes Simplex
• Infections

• NCT number: NCT01915212
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Status: Completed
• Phase: Phase 1
• Start date: September 26, 2013
• Completion date: March 6, 2017