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Pneumococcal Conjugate Vaccination in HIV in Comparison to Polysaccharide Vaccine Boosting

NCT00622843 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2025-06-08

Study results available
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Summary

Purpose: To study the immune response of the newly licensed pneumococcal conjugate vaccine (PCV) in comparison to the pneumococcal polysaccharide vaccine (PPV) to determine if a significantly better immunologic response to boosting can be elicited in patients previously vaccinated with PPV.

Conditions

  • HIV Infections
  • Streptococcus Pneumoniae

Interventions

BIOLOGICAL

pneumococcal conjugate vaccine

Prevnar is manufactured as a liquid preparation. Each 0.5 mL dose is formulated to contain: 2 μg of each saccharide for serotypes 4, 9V, 14, 18C, 19F, and 23F, and 4 μg of serotype 6B per dose (16 μg total saccharide); approximately 20 μg of CRM197 carrier protein; and 0.125 mg of aluminum per 0.5 mL dose as aluminum phosphate adjuvant. After shaking, the vaccine is a homogeneous, white suspension.

BIOLOGICAL

pneumococcal polysaccharide vaccine

PNEUMOVAX 23 is manufactured according to methods developed by the Merck Research Laboratories. Each 0.5 mL dose of vaccine contains 25 μg of each polysaccharide type in isotonic saline solution containing 0.25% phenol as a preservative.

Sponsors & Collaborators

  • Infectious Diseases Clinical Research Program

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • US Military HIV Research Program

    collaborator NETWORK

  • Uniformed Services University of the Health Sciences

    collaborator FED

  • Henry M. Jackson Foundation for the Advancement of Military Medicine

    lead OTHER

Principal Investigators

  • Brian Agan, MD · Uniformed Services University of the Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-12-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • United States

Study Locations

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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 NCT00622843 on ClinicalTrials.gov