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Early Versus Delayed Pneumococcal Vaccination in HIV

Primary Purpose

Pneumococcal Infections

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Pneumovax
Prevnar
Sponsored by
CIHR Canadian HIV Trials Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Infections focused on measuring HIV, HIV Infections

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Arts Health Research Group
  • Downtown IDC
  • St. Paul's Hospital
  • St. Boniface General Hospital
  • Moncton Hospital
  • Victoria General
  • McMaster University
  • St. Joseph's Hospital
  • Sunnybrook
  • Toronto General
  • Metropolitan Hospital
  • Montreal Chest/Royal-Victoria
  • Centre Hospitalier Universitaire de Sherbrooke
  • Centre Hospitalier Universitaire de Laval

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Pneumovax/immediate

Pneumovax/delayed

Prevnar/immediate

Prevnar/delayed

Arm Description

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
August 26, 2005
Last Updated
February 11, 2014
Sponsor
CIHR Canadian HIV Trials Network
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00137605
Brief Title
Early Versus Delayed Pneumococcal Vaccination in HIV
Official Title
A Pilot Study Assessing the Efficacy of Pneumococcal Vaccine in HIV Patients: Delayed Versus Immediate Immunization
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
CIHR Canadian HIV Trials Network
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Infections
Keywords
HIV, HIV Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pneumovax/immediate
Arm Type
Experimental
Arm Title
Pneumovax/delayed
Arm Type
Experimental
Arm Title
Prevnar/immediate
Arm Type
Experimental
Arm Title
Prevnar/delayed
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Pneumovax
Intervention Type
Biological
Intervention Name(s)
Prevnar
Primary Outcome Measure Information:
Title
Number of serotypes to which a response is found
Title
A response is defined as a doubling in antibody titer at 1 month compared to baseline.
Secondary Outcome Measure Information:
Title
Antibody response at 6 months and one year
Title
Changes in viral load 3 months post immunization
Title
Adverse events
Title
Overall incidence of invasive pneumococcal disease
Title
Incidence of invasive pneumococcal disease between vaccines

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Schlech, MD
Organizational Affiliation
Victoria General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Arts Health Research Group
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1T2
Country
Canada
Facility Name
Downtown IDC
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
St. Boniface General Hospital
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Moncton Hospital
City
Windsor
State/Province
New Brunswick
Country
Canada
Facility Name
Victoria General
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
St. Joseph's Hospital
City
London
State/Province
Ontario
Country
Canada
Facility Name
Sunnybrook
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Toronto General
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Metropolitan Hospital
City
Windsor
State/Province
Ontario
Country
Canada
Facility Name
Montreal Chest/Royal-Victoria
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Laval
City
Ste-Foy
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23535358
Citation
Slayter KL, Singer J, Lee TC, Kayhty H, Schlech WF. Immunization against pneumococcal disease in HIV-infected patients: conjugate versus polysaccharide vaccine before or after reconstitution of the immune system (CTN-147). Int J STD AIDS. 2013 Mar;24(3):227-31. doi: 10.1177/0956462412472450. Epub 2013 May 6.
Results Reference
result
Links:
URL
http://www.hivnet.ubc.ca/clinical-studies/trial-results-2/ctn-147/
Description
CIHR Canadian HIV Trial Network, Study Results

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Early Versus Delayed Pneumococcal Vaccination in HIV

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