A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants
HIV Infections, Pneumococcal Infections
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring Vaccines, Synthetic, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Pneumococcal Infections, Bacterial Vaccines
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Antipyretics for rectal temperature >= 100.4 F. Antiretroviral therapy. Patients must have: HIV positivity. Birth weight at least 1800 g (3.75 lb). Consent and compliance of parent or guardian. NOTE: Coenrollment in other therapeutic protocols (except ACTG 218, 230, and 279) is permitted. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Enrollment in HIV vaccine trials. Major congenital anomalies that are incapacitating, result in immunologic abnormalities, or require major surgical procedures. Congenital immunoglobulin deficiency, SS or SC hemoglobinopathy, or asplenia. Hypogammaglobulinemia. Concurrent Medication: Excluded: Prophylactic antipyretics. Patients with the following prior conditions are excluded: Acute moderate to severe intercurrent illness or fever within 72 hours prior to study entry. Prior Medication: Excluded: Any prior pneumococcal vaccine. Measles vaccine within 1 month prior to study vaccination. Any other routine vaccine within 1 week prior to study vaccination. Any immunosuppressant agent, including prednisone, for more than 6 weeks. Prior Treatment: Excluded: Blood products within 56 days prior to study vaccination.
Sites / Locations
- Usc La Nichd Crs
- Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
- UCSD Maternal, Child, and Adolescent HIV CRS
- San Francisco Gen. Hosp.
- UCSF Pediatric AIDS CRS
- Univ. of Florida Jacksonville NICHD CRS
- Univ. of Miami Ped. Perinatal HIV/AIDS CRS
- Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
- Cook County Hosp.
- Chicago Children's CRS
- Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
- Tulane/LSU Maternal/Child CRS
- Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
- Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
- HMS - Children's Hosp. Boston, Div. of Infectious Diseases
- Children's Hospital of Michigan NICHD CRS
- UMDNJ - Robert Wood Johnson
- NJ Med. School CRS
- Bronx-Lebanon Hosp. IMPAACT CRS
- North Shore-Long Island Jewish Health System, Dept. of Peds.
- NYU Med. Ctr., Dept. of Medicine
- Columbia IMPAACT CRS
- Incarnation Children's Ctr.
- Harlem Hosp. Ctr. NY NICHD CRS
- Strong Memorial Hospital Rochester NY NICHD CRS
- SUNY Stony Brook NICHD CRS
- SUNY Upstate Med. Univ., Dept. of Peds.
- DUMC Ped. CRS
- The Children's Hosp. of Philadelphia IMPAACT CRS
- Texas Children's Hosp. CRS
- UW School of Medicine - CHRMC
- Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
- San Juan City Hosp. PR NICHD CRS
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
1
2
Patients receiving intramuscular heptavalent pneumococcal conjugate vaccine
Patients receiving placebo vaccine