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

Completed · Phase 1 · Has a placebo group

Conditions studied: HIV Infections, HIV Seronegativity

In brief

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.

Key facts

Study ID

NCT00000774

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

156

Expected to finish

1999-01-01

Last updated by the study team

2021-11-04

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Concurrent Medication:
• Allowed:
• Antiretroviral therapy.
• Coenrollment in a therapeutic protocol if begun at least 30 days following the week 20 immunization.
• Routine immunizations if given more than 1 week before or after study vaccine.
• Patients must be:
• > 37 weeks gestation and < 72 hours of age born to HIV-infected women.
• NOT born to women who received either passive or active immunotherapy during pregnancy.
• NOT breast-fed.
• NOT born to women who are hepatitis B surface antigen positive.
• Receiving AZT at study entry (except infants enrolled in ACTG 076).
• NOTE:
• Parent or guardian must provide informed consent and be willing to comply with study requirements.

You may not qualify if…

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Documented or suspected serious bacterial infection, metabolic illness, or other immediate life-threatening conditions.
• Concurrent Medication:
• Excluded:
• Passive or active HIV-specific immunotherapy other than the study candidate vaccines.
• Investigational medications.

Where it is running

• 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
• Cook County Hosp. — Chicago, Illinois, United States
• Chicago Children's CRS — Chicago, Illinois, United States
• Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease — Chicago, Illinois, United States
• Tulane Univ. Health Science Ctr., Tulane Univ. Hosp. & Clinic — New Orleans, Louisiana, United States
• Tulane/LSU Maternal/Child CRS — New Orleans, Louisiana, 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
• BMC, Div. of Ped Infectious Diseases — Boston, Massachusetts, United States
• HMS - Children's Hosp. Boston, Div. of Infectious Diseases — Boston, Massachusetts, United States
• Baystate Health, Baystate Med. Ctr. — Springfield, Massachusetts, 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
• 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

Full record on ClinicalTrials.gov

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