Safety and Immune Response Study of the Vaccine ALVAC vCP1452 Alone or in Combination With AIDSVAX B/B
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to see if the vaccines tested are safe when given alone and when
      given together, and how the immune system responds to the vaccines.

      Vaccines are given to people to try to prevent an infection or disease. Early testing in a
      few people has shown that the HIV vaccines ALVAC vCP1452 and AIDSVAX B/B seem to be safe to
      use.
    

Detailed description: 
      There is no cure for HIV infection or AIDS, and drug therapy is too expensive for most
      affected populations. For this reason, the development of safe, effective vaccines to prevent
      HIV infections worldwide is needed. ALVAC vCP1452 and MN rgp120/HIV-1 have been shown to be
      well tolerated in Phase I and II studies. ALVAC vCP1452 given alone or in combination with
      subunit antigens [AS PER AMENDMENT 10/12/00: antigen] is a candidate vaccine to be evaluated
      for the ability to produce and express vaccine antigen in greater quantity for a longer time
      and with improved immunogenicity.

      Volunteers are randomized to 1 of 7 [AS PER AMENDMENT 10/12/00: 1 of 4] groups and stratified
      by risk status. Prior to immunization, evaluations and blood draws are done to monitor
      hematological, chemical, and immunologic parameters. Volunteers receive 2 injections of the
      following vaccines at Months 0, 1, 3, and 6:

      Group A: ALVAC vCP1452 and alum placebo [AS PER AMENDMENT 10/12/00: AIDSVAX placebo (aluminum
      hydroxide adjuvant)] at Months 0, 1, 3, and 6.

      Group B: ALVAC vCP1452 and alum placebo [AS PER AMENDMENT 10/12/00: AIDSVAX placebo] at
      Months 0 and 1 and ALVAC vCP1452 and AIDSVAX B/B at Months 3 and 6.

      Group C: ALVAC placebo and alum placebo. [AS PER AMENDMENT 10/12/00: ALVAC vCP1452 and
      AIDSVAX B/B at Months 0, 1, and 6 and ALVAC vCP1452 and AIDSVAX placebo at Month 3.] Group D:
      ALVAC vCP1452 and alum placebo at Months 0 and 1 and ALVAC vCP1452 and MN rgp120 at Months 3
      and 6. [AS PER AMENDMENT 10/12/00: ALVAC placebo and AIDSVAX placebo at Months 0, 1, 3, and
      6.] Group E: ALVAC vCP1452 and AIDSVAX B/B at Months 0, 1, and 6; ALVAC vCP1452 and alum
      placebo at Month 3. [AS PER AMENDMENT 10/12/00: Group E has been discontinued.] Group F:
      ALVAC vCP1452 and AIDSVAX B/B. [AS PER AMENDMENT 10/12/00: Group F has been discontinued.]
      Group G: ALVAC vCP1452 and alum placebo at Months 0 and 1; ALVAC vCP1452 and AIDSVAX B/E at
      Months 3 and 6. [AS PER AMENDMENT 10/12/00: Group G has been discontinued.] Following each
      pair of injections, volunteers are observed in the clinic for 30 minutes. Volunteers keep a
      record of body temperature and any other symptoms and report results to their AIDS Vaccine
      Evaluation Unit. Evaluations are performed by telephone or clinic visit on Days 1 and 2 after
      each vaccination. [AS PER AMENDMENT 10/12/00: Volunteers record all relevant signs and
      symptoms occurring 48 hours after each vaccination and provide that information at each
      clinic visit.] HIV testing is conducted every 3 to 6 months and volunteers are asked to
      complete social harms questionnaires once at Day 168 and once at the end of the study.
      Volunteers are followed on the study for a minimum of 18 months after the first immunization.
      Safety is evaluated by closely monitoring for local and systemic adverse reactions during the
      course of the trial.
    

Intervention name(s): ALVAC(2)120(B,MN)GNP (vCP1452); MN rgp120/HIV-1 and GNE8 rgp120/HIV-1
Intervention type(s): Biological; Biological
Masking: Double
Primary purpose: Prevention
Keywords: Drug Therapy, Combination; HIV Envelope Protein gp120; AIDS Vaccines; CD8-Positive T-Lymphocytes; HIV Seronegativity; AIDSVAX; HIV Preventive Vaccine