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Clinical Trials/NCT00622843
NCT00622843CompletedPhase 3

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

Henry M. Jackson Foundation for the Advancement of Military Medicine6 sites in 1 country275 target enrollmentStarted: December 2002Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
275
Locations
6
Primary Endpoint
Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Group 1

Experimental

PCV, 210 patients

Intervention: pneumococcal conjugate vaccine (Biological)

Group 2

Active Comparator

PPV, 110 patients

Intervention: pneumococcal polysaccharide vaccine (Biological)

Group 3

Active Comparator

PCV, HIV-negative, 25 patients

Intervention: pneumococcal conjugate vaccine (Biological)

Outcomes

Primary Outcomes

Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms

Time Frame: Day 14, 60, and 180 after vaccination

The primary end point is greater than or equal to a 2-fold increase in the IgG level for at least 2 of the 4 serotypes on day 60, with levels greater than or equal to 1000 ng/mL.

Adverse Events (AEs) Occurring Temporally (Within 7 Days) in Association With Pneumococcal Vaccination

Time Frame: Day 7 after vaccination

Secondary Outcomes

  • Assessment of the Importance of the Host Immune Status (CD4+ Count) on the PCV and PPV Immunologic Response.(Day 60 after vaccination)
  • Assessment of CD4+ Cell Count Changes Caused by Vaccination With PCV and PPV.(Day 14, 60, and 180 after vaccination)
  • Assessment of Viral Load Changes Caused by Vaccination With PCV and PPV.(Day 14, 60, and 180 after vaccination)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Brian Agan

Deputy Science Director, IDCRP

Henry M. Jackson Foundation for the Advancement of Military Medicine

Study Sites (6)

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