Status:
COMPLETED
Early Versus Delayed Pneumococcal Vaccination in HIV
Lead Sponsor:
CIHR Canadian HIV Trials Network
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Pneumococcal Infections
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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 del...
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 heptav...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00137605
Start Date
September 1 2004
End Date
October 1 2007
Last Update
February 13 2014
Active Locations (14)
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1
Medical Arts Health Research Group
Kelowna, British Columbia, Canada, V1Y 1T2
2
Downtown IDC
Vancouver, British Columbia, Canada
3
St. Paul's Hospital
Vancouver, British Columbia, Canada
4
St. Boniface General Hospital
Winnipeg, Manitoba, Canada