NCT00622843

Pneumococcal Conjugate Vaccination in HIV in Comparison to Polysaccharide Vaccine Boosting

An Open-Label, Phase III, Randomized Study of Pneumococcal Conjugate Vaccination in HIV, in Comparison to Polysaccharide Vaccine Boosting in Previously Vaccinated Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 275 (actual)
• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2002-12-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2008-02-25
• Last updated: 2025-06-08
• Results posted: 2025-06-08

Locations

6 sites across 1 country: United States