Early Versus Delayed Pneumococcal Vaccination in HIV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00137605
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : February 13, 2014
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
CIHR Canadian HIV Trials Network

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.

Condition or disease Intervention/treatment Phase
Pneumococcal Infections Biological: Pneumovax Biological: Prevnar Phase 1 Phase 2

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  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pilot Study Assessing the Efficacy of Pneumococcal Vaccine in HIV Patients: Delayed Versus Immediate Immunization
Study Start Date : September 2004
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Pneumovax/immediate Biological: Pneumovax
Experimental: Pneumovax/delayed Biological: Pneumovax
Experimental: Prevnar/immediate Biological: Prevnar
Experimental: Prevnar/delayed Biological: Prevnar

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

Secondary Outcome Measures :
  1. Antibody response at 6 months and one year
  2. Changes in viral load 3 months post immunization
  3. Adverse events
  4. Overall incidence of invasive pneumococcal disease
  5. Incidence of invasive pneumococcal disease between vaccines

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00137605

Canada, British Columbia
Medical Arts Health Research Group
Kelowna, British Columbia, Canada, V1Y 1T2
Downtown IDC
Vancouver, British Columbia, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Canada, Manitoba
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
Canada, New Brunswick
Moncton Hospital
Windsor, New Brunswick, Canada
Canada, Nova Scotia
Victoria General
Halifax, Nova Scotia, Canada
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada
St. Joseph's Hospital
London, Ontario, Canada
Toronto, Ontario, Canada
Toronto General
Toronto, Ontario, Canada
Metropolitan Hospital
Windsor, Ontario, Canada
Canada, Quebec
Montreal Chest/Royal-Victoria
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Centre Hospitalier Universitaire de Laval
Ste-Foy, Quebec, Canada
Sponsors and Collaborators
CIHR Canadian HIV Trials Network
Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Walter Schlech, MD Victoria General Hospital

Publications of Results: Identifier: NCT00137605     History of Changes
Other Study ID Numbers: CTN 147
Control # 078760
File # 9427-C1574-34C
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: February 13, 2014
Last Verified: February 2014

Keywords provided by CIHR Canadian HIV Trials Network:
HIV Infections

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs