A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants
- Conditions
- Pneumococcal InfectionsHIV Infections
- Interventions
- Biological: Pneumococcal Vaccine, Polyvalent (23-valent)Biological: Pneumococcal Conjugate Vaccine, HeptavalentBiological: Placebo
- Registration Number
- NCT00000829
- 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
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Pneumococcal Vaccine, Polyvalent (23-valent) Patients receiving intramuscular heptavalent pneumococcal conjugate vaccine 2 Pneumococcal Vaccine, Polyvalent (23-valent) Patients receiving placebo vaccine 1 Pneumococcal Conjugate Vaccine, Heptavalent Patients receiving intramuscular heptavalent pneumococcal conjugate vaccine 2 Placebo Patients receiving placebo vaccine
- Primary Outcome Measures
Name Time Method Comparison of seroconversion rates and changes in (IgG) ELISA antibody levels between PCV and placebo patients after the primary series Throughout study Comparison of adverse reactions between PCV and placebo patients that occur within 48 hours after each injection Throughout study
- Secondary Outcome Measures
Name Time Method 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 patients At 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 parameters Throughout 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 placebo Prior 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 patients Throughout 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