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

August 26, 2005
February 11, 2014
September 2004
Not Provided
  • 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.
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.
Complete list of historical versions of study NCT00137605 on ClinicalTrials.gov Archive Site
  • 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
  • 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
Not Provided
Not Provided
 
Early Versus Delayed Pneumococcal Vaccination in HIV
A Pilot Study Assessing the Efficacy of Pneumococcal Vaccine in HIV Patients: Delayed Versus Immediate Immunization

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Pneumococcal Infections
  • Biological: Pneumovax
  • Biological: Prevnar
  • Experimental: Pneumovax/immediate
    Intervention: Biological: Pneumovax
  • Experimental: Pneumovax/delayed
    Intervention: Biological: Pneumovax
  • Experimental: Prevnar/immediate
    Intervention: Biological: Prevnar
  • Experimental: Prevnar/delayed
    Intervention: Biological: Prevnar
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
79
October 2007
Not Provided

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00137605
CTN 147, Control # 078760, File # 9427-C1574-34C
Not Provided
Not Provided
CIHR Canadian HIV Trials Network
Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Walter Schlech, MD Victoria General Hospital
CIHR Canadian HIV Trials Network
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP