A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants
NCT ID: NCT00000829
Last Updated: 2021-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
60 participants
INTERVENTIONAL
1999-10-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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1
Patients receiving intramuscular heptavalent pneumococcal conjugate vaccine
Pneumococcal Vaccine, Polyvalent (23-valent)
Administered as an injection at 24 months of age
Pneumococcal Conjugate Vaccine, Heptavalent
Administered as an injection at 0, 2, 4, and 15 months of age
2
Patients receiving placebo vaccine
Pneumococcal Vaccine, Polyvalent (23-valent)
Administered as an injection at 24 months of age
Placebo
Administered at 0, 2, 4, and 15 months of age
Interventions
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Pneumococcal Vaccine, Polyvalent (23-valent)
Administered as an injection at 24 months of age
Pneumococcal Conjugate Vaccine, Heptavalent
Administered as an injection at 0, 2, 4, and 15 months of age
Placebo
Administered at 0, 2, 4, and 15 months of age
Eligibility Criteria
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Inclusion Criteria
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
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.
2 Months
6 Months
ALL
No
Sponsors
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Lederle-Praxis Biologicals
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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James King, Jr, M.D.
Role: STUDY_CHAIR
University of Maryland, College Park
Sharon Nachman, M.D.
Role: STUDY_CHAIR
SUNY at Stony Brook
Locations
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Usc La Nichd Crs
Los Angeles, California, United States
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, United States
UCSD Maternal, Child, and Adolescent HIV CRS
San Diego, California, United States
San Francisco Gen. Hosp.
San Francisco, California, United States
UCSF Pediatric AIDS CRS
San Francisco, California, United States
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, United States
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, 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
Chicago Children's CRS
Chicago, Illinois, United States
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois, United States
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, United States
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
Baltimore, Maryland, United States
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States
Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, United States
UMDNJ - Robert Wood Johnson
New Brunswick, New Jersey, United States
NJ Med. School CRS
Newark, New Jersey, United States
North Shore-Long Island Jewish Health System, Dept. of Peds.
Great Neck, New York, United States
NYU Med. Ctr., Dept. of Medicine
New York, New York, United States
Columbia IMPAACT CRS
New York, New York, United States
Incarnation Children's Ctr.
New York, New York, United States
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, United States
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York, United States
SUNY Stony Brook NICHD CRS
Stony Brook, New York, United States
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, United States
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, United States
DUMC Ped. CRS
Durham, North Carolina, United States
The Children's Hosp. of Philadelphia IMPAACT CRS
Philadelphia, Pennsylvania, United States
Texas Children's Hosp. CRS
Houston, Texas, 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
Countries
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Other Identifiers
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11268
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 292
Identifier Type: -
Identifier Source: org_study_id