Clinical Trial: A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants

This study is no longer recruiting patients.

Sponsored by: Lederle-Praxis Biologicals
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

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

MedlinePlus related topics:  AIDS;   Streptococcal Infections;   Throat Disorders

Study Type: Interventional
Study Design: Prevention, Double-Blind

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.

Eligibility

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.

Location Information


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

More Information

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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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