Study of the Safety of a Particular Herpes Vaccine in Adults With or Without Herpes Infection
Condition: Healthy Volunteers
MeSH terms: Infections; Herpes Simplex
Study type: Interventional
Phase: Phase 1

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.
    

Detailed 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.
    

Intervention name(s): HSV529; Placebo
Intervention type(s): Biological; Other
Intervention description(s): The vaccine was administered intramuscularly (deltoid muscle) as a 0.5 mL solution containing 1 x 10(7) plaque forming units on day 0, one month after the first dose (day 30) and then six months after the first dose (day 180).; Sodium Chloride 0.9%
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Vaccination; Replication Defective; Genital Herpes; Safety; Immune Responses