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

Phase 1
Completed
Conditions
Pneumococcal Infections
HIV Infections
Interventions
Biological: Pneumococcal Vaccine, Polyvalent (23-valent)
Biological: Pneumococcal Conjugate Vaccine, Heptavalent
Biological: Placebo
Registration Number
NCT00000829
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1Pneumococcal Vaccine, Polyvalent (23-valent)Patients receiving intramuscular heptavalent pneumococcal conjugate vaccine
2Pneumococcal Vaccine, Polyvalent (23-valent)Patients receiving placebo vaccine
1Pneumococcal Conjugate Vaccine, HeptavalentPatients receiving intramuscular heptavalent pneumococcal conjugate vaccine
2PlaceboPatients receiving placebo vaccine
Primary Outcome Measures
NameTimeMethod
Comparison of seroconversion rates and changes in (IgG) ELISA antibody levels between PCV and placebo patients after the primary seriesThroughout study
Comparison of adverse reactions between PCV and placebo patients that occur within 48 hours after each injectionThroughout study
Secondary Outcome Measures
NameTimeMethod
To compare the decline of serum total IgG, IgG1, IgG2, and IgA pneumococcal type specific antibody after the 3rd and after the 4th vaccination in PCV versus placebo patientsAt a time after the 3rd vaccination and at a time after the 4th vaccination
Modeling of the rates of seroconversion and changes in serum antibody levels in PCV patients, after the primary series and booster series, to clinical HIV staging and T-lymphocyte parameters, as well as B-lymphocyte parametersThroughout study
Comparison of booster rates in serum ELISA (IgG) antibody levels just before the 4th vaccination and one month after the 4th vaccination in children receiving PCV and placeboPrior to 4th vaccination and at 1 month after 4th vaccination
Comparison of serum IgG1 and IgG2 subclass and IgA type specific seroconversion rates and changes in antibody levels in response to the primary immunization series and booster vaccination between PCV and placebo patientsThroughout study

Trial Locations

Locations (33)

The Children's Hosp. of Philadelphia IMPAACT CRS

🇺🇸

Philadelphia, Pennsylvania, United States

SUNY Upstate Med. Univ., Dept. of Peds.

🇺🇸

Syracuse, New York, United States

UMDNJ - Robert Wood Johnson

🇺🇸

New Brunswick, New Jersey, United States

SUNY Stony Brook NICHD CRS

🇺🇸

Stony Brook, New York, United States

Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.

🇺🇸

Oakland, California, United States

Univ. of Florida Jacksonville NICHD CRS

🇺🇸

Jacksonville, Florida, United States

Tulane/LSU Maternal/Child CRS

🇺🇸

New Orleans, Louisiana, United States

NYU Med. Ctr., Dept. of Medicine

🇺🇸

New York, New York, United States

Strong Memorial Hospital Rochester NY NICHD CRS

🇺🇸

Rochester, New York, United States

Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology

🇺🇸

Baltimore, Maryland, United States

Harlem Hosp. Ctr. NY NICHD CRS

🇺🇸

New York, New York, United States

Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases

🇺🇸

Baltimore, Maryland, United States

NJ Med. School CRS

🇺🇸

Newark, New Jersey, United States

Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases

🇺🇸

Atlanta, Georgia, United States

Cook County Hosp.

🇺🇸

Chicago, Illinois, United States

Univ. of Miami Ped. Perinatal HIV/AIDS CRS

🇺🇸

Miami, Florida, United States

Texas Children's Hosp. CRS

🇺🇸

Houston, Texas, United States

Usc La Nichd 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

Chicago Children's CRS

🇺🇸

Chicago, Illinois, United States

Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease

🇺🇸

Chicago, Illinois, United States

HMS - Children's Hosp. Boston, Div. of Infectious Diseases

🇺🇸

Boston, Massachusetts, United States

Columbia IMPAACT CRS

🇺🇸

New York, New York, United States

North Shore-Long Island Jewish Health System, Dept. of Peds.

🇺🇸

Great Neck, New York, United States

Incarnation Children's Ctr.

🇺🇸

New York, New York, United States

Bronx-Lebanon Hosp. IMPAACT CRS

🇺🇸

Bronx, New York, United States

DUMC Ped. CRS

🇺🇸

Durham, North Carolina, United States

UW School of Medicine - CHRMC

🇺🇸

Seattle, Washington, United States

Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS

🇵🇷

San Juan, Puerto Rico

San Juan City Hosp. PR NICHD CRS

🇵🇷

San Juan, Puerto Rico

UCSF Pediatric AIDS CRS

🇺🇸

San Francisco, California, United States

Children's Hospital of Michigan NICHD CRS

🇺🇸

Detroit, Michigan, United States

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