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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

NCT00000829 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-10-28

No results posted yet for this study

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.

Conditions

  • HIV Infections
  • Pneumococcal Infections

Interventions

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

BIOLOGICAL

Placebo

Administered at 0, 2, 4, and 15 months of age

Sponsors & Collaborators

  • Lederle-Praxis Biologicals

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • James King, Jr, M.D. · University of Maryland, College Park

  • Sharon Nachman, M.D. · SUNY at Stony Brook

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Completion
1999-10-31

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00000829 on ClinicalTrials.gov