A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers
Condition: HIV Infections; HIV Seronegativity
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      PRIMARY: To determine the safety of envelope recombinant proteins rgp120/HIV-1MN (Genentech)
      and rgp120/HIV-1SF2 (Chiron/Biocine) in infants who are of indeterminate HIV status born to
      HIV-infected women. To evaluate changes in viral load in infants proven to be infected and
      absolute CD4 counts in all immunized infants.

      SECONDARY: To evaluate the immunogenicity of these envelope recombinant proteins in infants
      of indeterminate HIV status born to HIV-infected women.

      Only 30-50 percent of HIV-infected infants have detectable virus at birth. Successful early
      sensitization to HIV envelope epitopes may help prevent infection or, alternatively, may
      enhance HIV-specific immune function to alter HIV replication and disease progression.
    

Detailed description: 
      Only 30-50 percent of HIV-infected infants have detectable virus at birth. Successful early
      sensitization to HIV envelope epitopes may help prevent infection or, alternatively, may
      enhance HIV-specific immune function to alter HIV replication and disease progression.

      Newborns are randomized to one of three different doses of either rgp120/HIV-1MN or
      rgp120/HIV-1SF2 or their matching placebos. At each dose level, 12 patients receive vaccine
      and three patients receive placebo. Immunizations are performed at 0, 4, 12, and 20 weeks,
      and patients are followed until 2 years of age. Three of four patients treated at a given
      dose level must have received two immunizations without evidence of grade 3 or 4 clinical or
      laboratory toxicity before dose escalation occurs. Twelve additional patients are treated
      with the optimal dose of each vaccine at weeks 0, 2, 8, and 20 (An accelerated schedule PER
      AMENDMENT 3/20/96. Changed from - 0, 4, 8, and 20) accompanied by three additional placebo
      patients per vaccine. PER AMENDMENT 3/20/96: The optimal dose of rgp120/HIV-1MN is 100 mcg
      and will be given to the 12 patients and the placebo will be given to 3. The optimal dose of
      rgp120/HIV-1SF2 is 5 mcg and will be given to the 12 patients and the placebo will be given
      to 3.

      PER 2/3/95 AMENDMENT: After the initial patients are enrolled, 18 additional newborns will be
      randomized to one of the three dose levels of rgp120/HIV-1MN (with no placebos). PER
      AMENDMENT 6/5/95: Another group of 18 newborns will be randomized to one of three treatments
      representing 3 different doses of the Chiron/Biocine vaccine (with no placebos).
    

Intervention name(s): rgp120/HIV-1MN; rgp120/HIV-1 SF-2; Placebo version of rgp120/HIV-1MN; Placebo version of rgp120/HIV-1SF2
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.; Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.; Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.; Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Vaccines, Synthetic; Virus Replication; HIV Envelope Protein gp120; AIDS Vaccines; HIV Preventive Vaccine; HIV Therapeutic Vaccine