Pneumococcal Conjugate Vaccination in HIV in Comparison to Polysaccharide Vaccine Boosting

Phase 3

Completed

• Conditions: HIV Infections; Streptococcus Pneumoniae
• Interventions: Biological: pneumococcal conjugate vaccine; Biological: pneumococcal polysaccharide vaccine

• Registration Number: NCT00622843
• Lead Sponsor: Uniformed Services University of the Health Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Study First Submitted: 2008-02-13
• Study First Submitted QC: 2008-02-22
• Study First Posted: 2008-02-25
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-07
• Last Update Posted: 2014-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 275

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	pneumococcal conjugate vaccine	PCV, 210 patients
Group 2	pneumococcal polysaccharide vaccine	PPV, 110 patients
Group 3	pneumococcal polysaccharide vaccine	PPV, HIV-negative, 25 patients

Primary Outcome Measures

Name	Time	Method
The measure of PPV and PCV efficacy will be assessed by the level of serotype-specific antibody levels, measured by ELISA.	Day 180 after vaccination

Trial Locations

Locations (6)

Tripler Army Medical Center; 🇺🇸 Tripler AMC, Hawaii, United States

Naval Medical Center San Diego; 🇺🇸 San Diego, California, United States

Walter Reed Army Medical Center; 🇺🇸 Washington, District of Columbia, United States

San Antonio Military Medical Center; 🇺🇸 Lackland AFB, Texas, United States

Naval Medical Center Portsmouth; 🇺🇸 Portsmouth, Virginia, United States

National Naval Medical Center; 🇺🇸 Bethesda, Maryland, United States