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

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



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

For Condition: HIV Infections,Pneumococcal Infections
Status: No longer recruiting
Sponsor(s): Lederle-Praxis Biologicals ,
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Prevention, Double-Blind
Minimum Age/Maximum Age: 2 Months/6 Months
Genders: Both
Protocol Entry 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.
Total Enrollment: 60

Location and Contact Information:

Overall Study Official:
KingJ,  Study Chair, 

Duke Univ Med Ctr
Durham,  North Carolina,  277103499
United States
 

Children's Hosp of Michigan
Detroit,  Michigan,  48201
United States
 

Children's Hosp of Oakland
Oakland,  California,  946091809
United States
 

Univ of Florida Health Science Ctr / Pediatrics
Jacksonville,  Florida,  32209
United States
 

Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York City,  New York,  10032
United States
 

Univ of Miami (Pediatric)
Miami,  Florida,  33161
United States
 

Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark,  New Jersey,  071072198
United States
 

Bellevue Hosp / New York Univ Med Ctr
New York City,  New York,  10016
United States
 

Cook County Hosp
Chicago,  Illinois,  60612
United States
 

Tulane Univ / Charity Hosp of New Orleans
New Orleans,  Louisiana,  701122699
United States
 

Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan,  ,  009365067
Puerto Rico
 

UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick,  New Jersey,  089030019
United States
 

UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla,  California,  920930672
United States
 

Chicago Children's Memorial Hosp
Chicago,  Illinois,  606143394
United States
 

Columbus Children's Hosp
Columbus,  Ohio,  432052696
United States
 

State Univ of New York at Stony Brook
Stony Brook,  New York,  117948111
United States
 

Univ of Chicago Children's Hosp
Chicago,  Illinois,  606371470
United States
 

Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark,  New Jersey,  071032714
United States
 

UCSF / Moffitt Hosp - Pediatric
San Francisco,  California,  941430105
United States
 

Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore,  Maryland,  21201
United States
 

Emory Univ Hosp / Pediatrics
Atlanta,  Georgia,  30306
United States
 

Univ of Rochester Med Ctr
Rochester,  New York,  146420001
United States
 

Children's Hospital & Medical Center / Seattle ACTU
Seattle,  Washington,  981050371
United States
 

Bronx Lebanon Hosp Ctr
Bronx,  New York,  10457
United States
 

Columbia Presbyterian Med Ctr
New York City,  New York,  10032
United States
 

Johns Hopkins Hosp - Pediatric
Baltimore,  Maryland,  212874933
United States
 

Children's Hosp of Boston
Boston,  Massachusetts,  021155724
United States
 

Harlem Hosp Ctr
New York City,  New York,  10037
United States
 

San Francisco Gen Hosp
San Francisco,  California,  94110
United States
 

North Shore Univ Hosp
Great Neck,  New York,  11021
United States
 

Mount Sinai Med Ctr / Pediatrics
New York City,  New York,  10029
United States
 

Cornell Univ Med College
New York City,  New York,  10021
United States
 

Children's Hosp of Philadelphia
Philadelphia,  Pennsylvania,  191044318
United States
 

Nassau County Med Ctr
East Meadow,  New York,  11554
United States
 

SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse,  New York,  13210
United States
 

Los Angeles County - USC Med Ctr
Los Angeles,  California,  90033
United States
 

Texas Children's Hosp / Baylor Univ
Houston,  Texas,  77030
United States
 


Additional Information:
Study ID Numbers:
  ACTG 292; 
Study Start Date: 
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000829

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