NCT00000774

A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 1 Day – 3 Days
• Healthy volunteers: Accepted

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).

Conditions

• HIV Infections
• HIV Seronegativity

Interventions

Type	Name	Description
BIOLOGICAL	rgp120/HIV-1MN	Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.
BIOLOGICAL	rgp120/HIV-1 SF-2	Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.
BIOLOGICAL	Placebo version of rgp120/HIV-1MN	Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.
BIOLOGICAL	Placebo version of rgp120/HIV-1SF2	Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.

Timeline

• Completion: 1999-01-01
• First posted: 2001-08-31
• Last updated: 2021-11-04

Locations

37 sites across 2 countries: United States, Puerto Rico