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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Lederle-Praxis Biologicals |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000829 |
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 | Intervention | Phase |
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HIV Infections Pneumococcal Infections |
Biological: Pneumococcal Vaccine, Polyvalent (23-valent) Biological: Pneumococcal Conjugate Vaccine, Heptavalent Biological: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment |
Official Title: | A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants |
Enrollment: | 60 |
Study Start Date: | November 1999 |
Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Patients receiving intramuscular heptavalent pneumococcal conjugate vaccine
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Biological: Pneumococcal Vaccine, Polyvalent (23-valent)
Administered as an injection at 24 months of age
Biological: Pneumococcal Conjugate Vaccine, Heptavalent
Administered as an injection at 0, 2, 4, and 15 months of age
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2: Placebo Comparator
Patients receiving placebo vaccine
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Biological: Pneumococcal Vaccine, Polyvalent (23-valent)
Administered as an injection at 24 months of age
Biological: Placebo
Administered at 0, 2, 4, and 15 months of age
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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.
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.
Ages Eligible for Study: | 2 Months to 6 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
NOTE:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
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:
Prior Treatment:
Excluded:
Study Chair: | James King, Jr, M.D. | University of Maryland School of Medicine |
Study Chair: | Sharon Nachman, M.D. | SUNY at Stony Brook |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | ACTG 292 |
Study First Received: | November 2, 1999 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00000829 |
Health Authority: | United States: Food and Drug Administration |
Vaccines, Synthetic Acquired Immunodeficiency Syndrome AIDS-Related Complex Pneumococcal Infections Bacterial Vaccines |
Bacterial Infections Virus Diseases Gram-Positive Bacterial Infections Sexually Transmitted Diseases, Viral Streptococcal Infections HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome AIDS-Related Complex Retroviridae Infections Pneumococcal Infections Immunologic Deficiency Syndromes |
Communicable Diseases RNA Virus Infections Slow Virus Diseases |
Immune System Diseases Lentivirus Infections Infection |