To assess whether HIV-infected infants who receive a heptavalent pneumococcal conjugate vaccine have more local reactions at the site of injection and systemic reactions than placebo subjects. To assess whether this vaccine is more immunogenic than placebo following the third vaccination. Children with HIV infection are at increased risk for invasive pneumococcal infection, particularly bacteremia. A large proportion of pneumococcal disease is caused by a limited number of serotypes. The maximum number of pneumococcal serotypes that can be included in a new conjugate vaccine is felt to be limited by the amount of carrier protein. A heptavalent pneumococcal conjugate vaccine has been developed that consists of pneumococcal capsular saccharides from serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F bound to a diphtheria toxin mutant carrier protein.

Condition	Treatment or Intervention	Phase
HIV Infections Pneumococcal Infections	Vaccine: Pneumococcal Vaccine, Polyvalent (23-valent)  Vaccine: Pneumococcal Conjugate Vaccine, Heptavalent	Phase I

Further Study Details: 

Expected Total Enrollment:  60

Children with HIV infection are at increased risk for invasive pneumococcal infection, particularly bacteremia. A large proportion of pneumococcal disease is caused by a limited number of serotypes. The maximum number of pneumococcal serotypes that can be included in a new conjugate vaccine is felt to be limited by the amount of carrier protein. A heptavalent pneumococcal conjugate vaccine has been developed that consists of pneumococcal capsular saccharides from serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F bound to a diphtheria toxin mutant carrier protein.

Infants are randomized to receive either heptavalent pneumococcal conjugate vaccine or placebo by intramuscular injection at study months 0, 2, and 4, and then at 15 months of age. Additionally, patients receive PNU-IMUNE 23 ( pneumococcal polyvalent vaccine ) at 24 months of age.

Ages Eligible for Study:  2 Months   -   6 Months,  Genders Eligible for Study:  Both

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.

California
      UCSF / Moffitt Hosp - Pediatric, San Francisco,  California,  941430105,  United States
      UCSD Med Ctr / Pediatrics / Clinical Sciences, La Jolla,  California,  920930672,  United States
      San Francisco Gen Hosp, San Francisco,  California,  94110,  United States
      Children's Hosp of Oakland, Oakland,  California,  946091809,  United States
      Los Angeles County - USC Med Ctr, Los Angeles,  California,  90033,  United States
Florida
      Univ of Miami (Pediatric), Miami,  Florida,  33161,  United States
      Univ of Florida Health Science Ctr / Pediatrics, Jacksonville,  Florida,  32209,  United States
Georgia
      Emory Univ Hosp / Pediatrics, Atlanta,  Georgia,  30306,  United States
Illinois
      Chicago Children's Memorial Hosp, Chicago,  Illinois,  606143394,  United States
      Cook County Hosp, Chicago,  Illinois,  60612,  United States
      Univ of Chicago Children's Hosp, Chicago,  Illinois,  606371470,  United States
Louisiana
      Tulane Univ / Charity Hosp of New Orleans, New Orleans,  Louisiana,  701122699,  United States
Maryland
      Univ of Maryland at Baltimore / Univ Med Ctr, Baltimore,  Maryland,  21201,  United States
      Johns Hopkins Hosp - Pediatric, Baltimore,  Maryland,  212874933,  United States
Massachusetts
      Children's Hosp of Boston, Boston,  Massachusetts,  021155724,  United States
Michigan
      Children's Hosp of Michigan, Detroit,  Michigan,  48201,  United States
New Jersey
      Univ of Medicine & Dentistry of New Jersey / Univ Hosp, Newark,  New Jersey,  071032714,  United States
      UMDNJ - Robert Wood Johnson Med School / Pediatrics, New Brunswick,  New Jersey,  089030019,  United States
      Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl, Newark,  New Jersey,  071072198,  United States
New York
      Harlem Hosp Ctr, New York,  New York,  10037,  United States
      Cornell Univ Med College, New York,  New York,  10021,  United States
      North Shore Univ Hosp, Great Neck,  New York,  11021,  United States
      Nassau County Med Ctr, East Meadow,  New York,  11554,  United States
      Bellevue Hosp / New York Univ Med Ctr, New York,  New York,  10016,  United States
      Columbia Presbyterian Med Ctr, New York,  New York,  10032,  United States
      Mount Sinai Med Ctr / Pediatrics, New York,  New York,  10029,  United States
      SUNY Health Sciences Ctr at Syracuse / Pediatrics, Syracuse,  New York,  13210,  United States
      Bronx Lebanon Hosp Ctr, Bronx,  New York,  10457,  United States
      Incarnation Children's Ctr / Columbia Presbyterian Med Ctr, New York,  New York,  10032,  United States
      State Univ of New York at Stony Brook, Stony Brook,  New York,  117948111,  United States
      Univ of Rochester Med Ctr, Rochester,  New York,  146420001,  United States
North Carolina
      Duke Univ Med Ctr, Durham,  North Carolina,  277103499,  United States
Ohio
      Columbus Children's Hosp, Columbus,  Ohio,  432052696,  United States
Pennsylvania
      Children's Hosp of Philadelphia, Philadelphia,  Pennsylvania,  191044318,  United States
Texas
      Texas Children's Hosp / Baylor Univ, Houston,  Texas,  77030,  United States
Washington
      Children's Hospital & Medical Center / Seattle ACTU, Seattle,  Washington,  981050371,  United States
Puerto Rico
      Univ of Puerto Rico / Univ Children's Hosp AIDS, San Juan,  009365067,  Puerto Rico

Study chairs or principal investigators

King J,  Study Chair
Nachman S,  Study Chair

Study ID Numbers:  ACTG 292
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000829
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08