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

Phase 1

Completed

• Conditions: HIV Infections; HIV Seronegativity

• Registration Number: NCT00000774
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief 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).

Study Timeline

• Study Completion: 1999-01
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Development of adverse clinical, laboratory, or immunological responses to any of the recombinant vaccines	Throughout study
Changes in viral load in infants found to be HIV infected	Throughout study
Changes in the slope of absolute CD4 counts in all immunized children	Throughout study

Secondary Outcome Measures

Name	Time	Method
Changes in immune response to the vaccine candidates	Throughout study

Trial Locations

Locations (37)

Long Beach Memorial Med. Ctr., Miller Children's Hosp.; 🇺🇸 Long Beach, California, United States

UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS; 🇺🇸 Los Angeles, California, United States

UCSD Maternal, Child, and Adolescent HIV CRS; 🇺🇸 San Diego, California, United States

San Francisco Gen. Hosp.; 🇺🇸 San Francisco, California, United States

UCSF Pediatric AIDS CRS; 🇺🇸 San Francisco, California, United States

Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases; 🇺🇸 Torrance, California, United States

Univ. of Colorado Denver NICHD CRS; 🇺🇸 Aurora, Colorado, United States

Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease; 🇺🇸 New Haven, Connecticut, United States

Univ. of Florida Jacksonville NICHD CRS; 🇺🇸 Jacksonville, Florida, United States

Univ. of Miami Ped. Perinatal HIV/AIDS CRS; 🇺🇸 Miami, Florida, United States

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