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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
79
Medical Arts Health Research Group
Kelowna, British Columbia, Canada
Downtown IDC
Vancouver, British Columbia, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
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.
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
Moncton Hospital
Windsor, New Brunswick, Canada
Victoria General
Halifax, Nova Scotia, Canada
McMaster University
Hamilton, Ontario, Canada
St. Joseph's Hospital
London, Ontario, Canada
Sunnybrook
Toronto, Ontario, Canada
Toronto General
Toronto, Ontario, Canada
...and 4 more locations