Early Versus Delayed Pneumococcal Vaccination in HIV

This study has been completed.
Sponsor:
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: February 11, 2014
Last verified: February 2014
  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
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

Enrollment: 79
Study Start Date: September 2004
Study Completion Date: October 2007
Arms Assigned Interventions
Experimental: Pneumovax/immediate Biological: Pneumovax
Experimental: Pneumovax/delayed Biological: Pneumovax
Experimental: Prevnar/immediate Biological: Prevnar
Experimental: Prevnar/delayed Biological: Prevnar

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137605

Locations
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
Sunnybrook
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
Investigators
Principal Investigator: Walter Schlech, MD Victoria General Hospital
  More Information

Additional Information:
Publications:
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: February 11, 2014
Health Authority: Canada: Health Canada

Keywords provided by CIHR Canadian HIV Trials Network:
HIV
HIV Infections

Additional relevant MeSH terms:
Infection
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on October 20, 2014