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Trial record 1 of 1 for:    NCT00137605
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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.
 
ClinicalTrials.gov Identifier: NCT00137605
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : February 13, 2014
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
CIHR Canadian HIV Trials Network

Tracking Information
First Submitted Date  ICMJE August 26, 2005
First Posted Date  ICMJE August 30, 2005
Last Update Posted Date February 13, 2014
Study Start Date  ICMJE September 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2005)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 29, 2005)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2005)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2005)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Versus Delayed Pneumococcal Vaccination in HIV
Official Title  ICMJE A Pilot Study Assessing the Efficacy of Pneumococcal Vaccine in HIV Patients: Delayed Versus Immediate Immunization
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Infections
Intervention  ICMJE
  • Biological: Pneumovax
  • Biological: Prevnar
Study Arms  ICMJE
  • Experimental: Pneumovax/immediate
    Intervention: Biological: Pneumovax
  • Experimental: Pneumovax/delayed
    Intervention: Biological: Pneumovax
  • Experimental: Prevnar/immediate
    Intervention: Biological: Prevnar
  • Experimental: Prevnar/delayed
    Intervention: Biological: Prevnar
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2014)
79
Original Enrollment  ICMJE
 (submitted: August 29, 2005)
80
Actual Study Completion Date  ICMJE October 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00137605
Other Study ID Numbers  ICMJE CTN 147
Control # 078760
File # 9427-C1574-34C
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE CIHR Canadian HIV Trials Network
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator: Walter Schlech, MD Victoria General Hospital
PRS Account CIHR Canadian HIV Trials Network
Verification Date February 2014

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