A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers
- Conditions
- HIV InfectionsHIV Seronegativity
- Interventions
- Biological: Placebo version of rgp120/HIV-1MNBiological: rgp120/HIV-1MNBiological: rgp120/HIV-1 SF-2Biological: Placebo version of rgp120/HIV-1SF2
- Registration Number
- NCT00000774
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 156
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 Placebo version of rgp120/HIV-1MN Patients who will receive the placebo counterpart of 120/HIV-1MN 1 rgp120/HIV-1MN Patients who will receive rgp120/HIV-1MN 2 rgp120/HIV-1 SF-2 Patients who will receive rgp120/HIV-1SF2 4 Placebo version of rgp120/HIV-1SF2 Patients who will receive the placebo counterpart of rgp120/HIV-1SF2
- 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)
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
🇺🇸Los Angeles, California, United States
Chicago Children's CRS
🇺🇸Chicago, Illinois, United States
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
🇺🇸Baltimore, Maryland, United States
Brigham and Women's Hosp., Div. of Infectious Disease
🇺🇸Boston, Massachusetts, United States
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
🇺🇸Chicago, Illinois, United States
BMC, Div. of Ped Infectious Diseases
🇺🇸Boston, Massachusetts, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
🇺🇸Boston, Massachusetts, United States
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
🇺🇸Miami, Florida, United States
UCSD Maternal, Child, and Adolescent HIV CRS
🇺🇸San Diego, California, United States
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
🇺🇸New Haven, Connecticut, United States
San Francisco Gen. Hosp.
🇺🇸San Francisco, California, United States
UCSF Pediatric AIDS CRS
🇺🇸San Francisco, California, United States
DUMC Ped. CRS
🇺🇸Durham, North Carolina, United States
San Juan City Hosp. PR NICHD CRS
🇵🇷San Juan, Puerto Rico
Texas Children's Hosp. CRS
🇺🇸Houston, Texas, United States
WNE Maternal Pediatric Adolescent AIDS CRS
🇺🇸Worcester, New York, United States
The Children's Hosp. of Philadelphia IMPAACT CRS
🇺🇸Philadelphia, Pennsylvania, United States
UW School of Medicine - CHRMC
🇺🇸Seattle, Washington, United States
Univ. of Pennsylvania Health System, Hosp. of the Univ. of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Univ. of Colorado Denver NICHD CRS
🇺🇸Aurora, Colorado, United States
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
🇺🇸Long Beach, California, United States
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
🇺🇸Torrance, California, United States
Univ. of Florida Jacksonville NICHD CRS
🇺🇸Jacksonville, Florida, United States
Cook County Hosp.
🇺🇸Chicago, Illinois, United States
Tulane Univ. Health Science Ctr., Tulane Univ. Hosp. & Clinic
🇺🇸New Orleans, Louisiana, United States
Baystate Health, Baystate Med. Ctr.
🇺🇸Springfield, Massachusetts, United States
Bronx-Lebanon Hosp. IMPAACT CRS
🇺🇸Bronx, New York, United States
NYU Med. Ctr., Dept. of Medicine
🇺🇸New York, New York, United States
Columbia IMPAACT CRS
🇺🇸New York, New York, United States
Incarnation Children's Ctr.
🇺🇸New York, New York, United States
Strong Memorial Hospital Rochester NY NICHD CRS
🇺🇸Rochester, New York, United States
SUNY Stony Brook NICHD CRS
🇺🇸Stony Brook, New York, United States
Univ. of Rochester ACTG CRS
🇺🇸Rochester, New York, United States
SUNY Upstate Med. Univ., Dept. of Peds.
🇺🇸Syracuse, New York, United States
Tulane/LSU Maternal/Child CRS
🇺🇸New Orleans, Louisiana, United States
NJ Med. School CRS
🇺🇸Newark, New Jersey, United States
St. Joseph's Hosp. & Med. Ctr. of New Jersey
🇺🇸Paterson, New Jersey, United States