A Study of the Effects of Giving Two Anti-HIV Vaccines to Babies of HIV-Positive Mothers
Condition: HIV Infections; HIV Seronegativity
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see if giving the ALVAC vCP1452 anti-HIV vaccine alone or
      with another vaccine called AIDSVAX B/B to babies of HIV-positive mothers is safe. The study
      will also look at how these vaccines affect a baby's immune system. Most HIV-positive
      children get HIV from their mothers during pregnancy or birth. Treatment with anti-HIV drugs
      can reduce the baby's risk of getting HIV. Vaccines also may help prevent HIV infection. This
      study will look at whether the ALVAC vCP1452 vaccine and the AIDSVAX B/B vaccine can help the
      body fight off HIV infection. There is no chance of getting HIV infection from the vaccines.
      (This study has been changed. In earlier versions, ALVAC vCP205 and AIDSVAX B/E were going to
      be used.)
    

Detailed description: 
      Transmission of HIV from an untreated infected mother to her offspring is thought to occur to
      some infants perinatally and others at parturition. It is possible that administration of an
      immunogenic vaccine can reduce the vertical transmission of HIV-1 or moderate its course in
      infected infants. Successful early sensitization to HIV epitopes might succeed in preventing
      HIV infection. Alternately, the enhancement of HIV-specific immune function might also
      succeed in modifying HIV replication and affecting disease progression.

      Sixty infants are treated in this randomized, double-blind study; 45 infants receive
      recombinant Canarypox virus, ALVAC-HIV vCP205, and 15 receive placebo. Mothers serve as proxy
      for their infants. All infants receive a minimum of four immunizations, at Weeks 0 (within 72
      hours of birth), 4, 8, and 12. Initially, 24 patients are randomized to receive one of two
      doses of vCP205 or a saline placebo. When a suitable subunit vaccine is available, the
      protocol will be amended and 36 additional infants will be randomized to receive vCP205 alone
      or with a subunit vaccine at Weeks 4 and 8 (or vaccine placebo with or without subunit
      placebo). [AS PER AMENDMENT 11/5/97: 18 infants receive ALVAC-HIV vCP205 at one of two doses
      and 6 receive placebo.] [AS PER AMENDMENT 9/9/99: Cohort 1 received vCP205. Cohort 2 received
      a higher dose of vCP205. Cohort A received vCP205 placebo (saline). Cohorts 1, 2, and A were
      double-blinded and closed to accrual in March 1999. As of September 1999, infants are
      randomized to one of four new cohorts. Cohort 3 receives vCP1452 at Weeks 0, 4, 8, and 12.
      Cohort 4 receives vCP1452 at Weeks 0 and 4, then receives vCP1452 plus AIDSVAX B/E gp120 at
      Weeks 8 and 12. Cohort B receives vCP1452 placebo at Weeks 0, 4, 8, and 12. Cohort C receives
      vCP1452 placebo at Weeks 0 and 4, then receives vCP1452 placebo plus AIDSVAX B/E placebo at
      Weeks 8 and 12. All infants are followed every 2 weeks for the first 14 weeks of life, and
      then every 6 months until age 2. Cord blood is used to establish autologous B cell lines, and
      CTL assays are performed to characterize the immune response to HIV. In addition, CD4 count,
      viral load, and mucosal antibody responses are measured. Immunized infants who are not
      infected with HIV serve as controls for the immunogenicity of the vaccines in the infected
      infants.] [AS PER AMENDMENT 1/24/00: AIDSVAX B/E has been replaced with AIDSVAX B/B.]
    

Intervention name(s): ALVAC(2)120(B,MN)GNP (vCP1452); MN rgp120/HIV-1 and GNE8 rgp120/HIV-1; ALVAC-HIV MN120TMG (vCP205)
Intervention type(s): Biological; Biological; Biological
Masking: Double
Primary purpose: Prevention
Keywords: Pregnancy; Pregnancy Complications, Infectious; AIDS Vaccines; Disease Transmission, Vertical; Avipoxvirus; HIV Preventive Vaccine; HIV Therapeutic Vaccine