Early Versus Delayed Pneumococcal Vaccination in HIV

February 11, 2014 updated by: CIHR Canadian HIV Trials Network

A Pilot Study Assessing the Efficacy of Pneumococcal Vaccine in HIV Patients: Delayed Versus Immediate Immunization

The purpose of this study is to determine whether people who are HIV-positive respond better to a vaccine for pneumonia-related disease when they are immunized immediately, or when immunization is delayed until the immune system has improved to a certain level. The study will also compare the effectiveness of polysaccharide and heptavalent vaccines.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A multicentre, randomized controlled trial using a two factorial design. Eighty patients will be randomly assigned to receive either Pneumovax (or Pneumo23 according to standard use at site) or heptavalent pneumococcal conjugate vaccine (Prevnar) prior to reconstitution of the immune system or will have immunization delayed until their CD4 count is greater than 200 cells/mm3 after the introduction of antiretroviral therapy. Randomization will be stratified by study centre. Variable block sizes will be used to try to prevent study personnel from guessing the next allocation. Random allocation lists will be generated by computer.

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1T2
        • Medical Arts Health Research Group
      • Vancouver, British Columbia, Canada
        • St. Paul's Hospital
      • Vancouver, British Columbia, Canada
        • Downtown IDC
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • St. Boniface General Hospital
    • New Brunswick
      • Windsor, New Brunswick, Canada
        • Moncton Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Victoria General
    • Ontario
      • Hamilton, Ontario, Canada
        • McMaster University
      • London, Ontario, Canada
        • St. Joseph's Hospital
      • Toronto, Ontario, Canada
        • Sunnybrook
      • Toronto, Ontario, Canada
        • Toronto General
      • Windsor, Ontario, Canada
        • Metropolitan Hospital
    • Quebec
      • Montreal, Quebec, Canada
        • Montreal Chest/Royal-Victoria
      • Sherbrooke, Quebec, Canada
        • Centre Hospitalier Universitaire de Sherbrooke
      • Ste-Foy, Quebec, Canada
        • Centre Hospitalier Universitaire de Laval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HIV-positive
  • Between 18 and 65 years of age
  • Have a CD4 cell count below 200 cells/mm3
  • Willing to begin/change antiretroviral therapy
  • Willing and able to provide informed consent

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Have had previous pneumococcal vaccination
  • Have had occurrence of pneumococcal infection (brain, blood or lung infections) in past 5 years
  • Have hypersensitivity to components of either vaccine
  • Have acute feverish illness at the time of vaccination
  • Have had splenectomy (removal of the spleen)
  • Have received treatment with IVIG within the last 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pneumovax/immediate
Biological: Pneumovax
Experimental: Pneumovax/delayed
Biological: Pneumovax
Experimental: Prevnar/immediate
Biological: Prevnar
Experimental: Prevnar/delayed
Biological: Prevnar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Number of serotypes to which a response is found
A response is defined as a doubling in antibody titer at 1 month compared to baseline.

Secondary Outcome Measures

Outcome Measure
Adverse events
Antibody response at 6 months and one year
Changes in viral load 3 months post immunization
Overall incidence of invasive pneumococcal disease
Incidence of invasive pneumococcal disease between vaccines

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CIHR Canadian HIV Trials Network

Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

  • Principal Investigator: Walter Schlech, MD, Victoria General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

August 26, 2005

First Submitted That Met QC Criteria

August 29, 2005

First Posted (Estimate)

August 30, 2005

Study Record Updates

Last Update Posted (Estimate)

February 13, 2014

Last Update Submitted That Met QC Criteria

February 11, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTN 147
  • Control # 078760
  • File # 9427-C1574-34C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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