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

About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Vaccines, Synthetic, Virus Replication, HIV Envelope Protein gp120, AIDS Vaccines, HIV Preventive Vaccine, HIV Therapeutic Vaccine
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria 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.
Sites / Locations
- Long Beach Memorial Med. Ctr., Miller Children's Hosp.
- UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
- UCSD Maternal, Child, and Adolescent HIV CRS
- San Francisco Gen. Hosp.
- UCSF Pediatric AIDS CRS
- Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
- Univ. of Colorado Denver NICHD CRS
- Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
- Univ. of Florida Jacksonville NICHD CRS
- Univ. of Miami Ped. Perinatal HIV/AIDS CRS
- Cook County Hosp.
- Chicago Children's CRS
- Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
- Tulane Univ. Health Science Ctr., Tulane Univ. Hosp. & Clinic
- Tulane/LSU Maternal/Child CRS
- Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
- Brigham and Women's Hosp., Div. of Infectious Disease
- BMC, Div. of Ped Infectious Diseases
- HMS - Children's Hosp. Boston, Div. of Infectious Diseases
- Baystate Health, Baystate Med. Ctr.
- NJ Med. School CRS
- St. Joseph's Hosp. & Med. Ctr. of New Jersey
- Bronx-Lebanon Hosp. IMPAACT CRS
- NYU Med. Ctr., Dept. of Medicine
- Columbia IMPAACT CRS
- Incarnation Children's Ctr.
- Strong Memorial Hospital Rochester NY NICHD CRS
- Univ. of Rochester ACTG CRS
- SUNY Stony Brook NICHD CRS
- SUNY Upstate Med. Univ., Dept. of Peds.
- WNE Maternal Pediatric Adolescent AIDS CRS
- DUMC Ped. CRS
- The Children's Hosp. of Philadelphia IMPAACT CRS
- Univ. of Pennsylvania Health System, Hosp. of the Univ. of Pennsylvania
- Texas Children's Hosp. CRS
- UW School of Medicine - CHRMC
- San Juan City Hosp. PR NICHD CRS
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Placebo Comparator
Placebo Comparator
1
2
3
4
Patients who will receive rgp120/HIV-1MN
Patients who will receive rgp120/HIV-1SF2
Patients who will receive the placebo counterpart of 120/HIV-1MN
Patients who will receive the placebo counterpart of rgp120/HIV-1SF2