Early Versus Delayed Pneumococcal Vaccination in HIV
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by CIHR Canadian HIV Trials Network.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
CIHR Canadian HIV Trials Network
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
CIHR Canadian HIV Trials Network
ClinicalTrials.gov Identifier:
NCT00137605
First received: August 26, 2005
Last updated: September 7, 2006
Last verified: September 2006
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pneumococcal Infections |
Biological: Pneumovax or Pneumo23 Biological: Prevnar |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Pilot Study Assessing the Efficacy of Pneumococcal Vaccine in HIV Patients: Delayed Versus Immediate Immunization |
Resource links provided by NLM:
Further study details as provided by CIHR Canadian HIV Trials Network:
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
| Estimated Enrollment: | 80 |
| Study Start Date: | April 2003 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00137605
Contacts
| Contact: Deborah Kraus, RN | 604-806-9431 | |
| Contact: Don Zarowny | 604-806-8378 |
Locations
| Canada, British Columbia | |
| Medical Arts Health Research Group | Recruiting |
| Kelowna, British Columbia, Canada, V1Y 1T2 | |
| Contact: Dwight Ferris, MD 250-862-4157 | |
| Principal Investigator: Dwight AN Ferris, MD | |
| Downtown IDC | Recruiting |
| Vancouver, British Columbia, Canada | |
| Contact 604-642-6429 | |
| Principal Investigator: Brian Conway, MD | |
| St. Paul's Hospital | Recruiting |
| Vancouver, British Columbia, Canada | |
| Contact 604-806-8036 | |
| Principal Investigator: Julio Montaner, MD | |
| Canada, Manitoba | |
| St. Boniface General Hospital | Recruiting |
| Winnipeg, Manitoba, Canada | |
| Contact 204-237-2948 | |
| Principal Investigator: Stuart Rosser, MD | |
| Canada, New Brunswick | |
| Moncton Hospital | Recruiting |
| Windsor, New Brunswick, Canada | |
| Contact 506-857-5593 | |
| Principal Investigator: Gordon Dow, MD | |
| Canada, Nova Scotia | |
| Victoria General | Recruiting |
| Halifax, Nova Scotia, Canada | |
| Contact 902-473-5553 | |
| Principal Investigator: Walter Schlech, MD | |
| Canada, Ontario | |
| McMaster University | Recruiting |
| Hamilton, Ontario, Canada | |
| Contact 905-521-9800 | |
| Principal Investigator: Fiona Smaill, MD | |
| St. Joseph's Hospital | Recruiting |
| London, Ontario, Canada | |
| Contact 519-646-6207 | |
| Principal Investigator: William Thompson, MD | |
| Sunnybrook | Recruiting |
| Toronto, Ontario, Canada | |
| Contact 416-480-4689 | |
| Principal Investigator: Anita Rachlis, MD | |
| Toronto General | Recruiting |
| Toronto, Ontario, Canada | |
| Contact 416-340-3871 | |
| Principal Investigator: Sharon Walmsley, MD | |
| Metropolitan Hospital | Recruiting |
| Windsor, Ontario, Canada | |
| Contact 519-254-6115 | |
| Principal Investigator: Corinna Quan, MD | |
| Canada, Quebec | |
| Montreal Chest/Royal-Victoria | Recruiting |
| Montreal, Quebec, Canada | |
| Contact 514-843-2090 | |
| Principal Investigator: Richard Lalonde, MD | |
| Centre Hospitalier Universitaire de Sherbrooke | Recruiting |
| Sherbrooke, Quebec, Canada | |
| Contact 819-564-5321 | |
| Principal Investigator: Alain Piché, MD | |
| Centre Hospitalier Universitaire de Laval | Recruiting |
| Ste-Foy, Quebec, Canada | |
| Contact 418-654-2705 | |
| Principal Investigator: Sylvie Trottier, MD | |
Sponsors and Collaborators
CIHR Canadian HIV Trials Network
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| Principal Investigator: | Walter Schlech, MD | Victoria General Hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00137605 History of Changes |
| Other Study ID Numbers: | CTN 147, Control # 078760, File # 9427-C1574-34C |
| Study First Received: | August 26, 2005 |
| Last Updated: | September 7, 2006 |
| Health Authority: | Canada: Health Canada |
Keywords provided by CIHR Canadian HIV Trials Network:
|
HIV HIV Infections |
Additional relevant MeSH terms:
|
Pneumococcal Infections Streptococcal Infections Gram-Positive Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on May 16, 2013