Clinical trial NCT00137605: Early Versus Delayed Pneumococcal Vaccination in HIV
Official title: A Pilot Study Assessing the Efficacy of Pneumococcal Vaccine in HIV Patients: Delayed Versus Immediate Immunization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pneumococcal Infections
Keywords: HIV
HIV Infections
Lead sponsor: CIHR Canadian HIV Trials Network
Sponsor class: NETWORK
Collaborators: name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2005-08-30
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Number of serotypes to which a response is found
measure: A response is defined as a doubling in antibody titer at 1 month compared to baseline.
Secondary outcomes:
measure: Antibody response at 6 months and one year
measure: Changes in viral load 3 months post immunization
measure: Adverse events
measure: Overall incidence of invasive pneumococcal disease
measure: Incidence of invasive pneumococcal disease between vaccines
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: Medical Arts Health Research Group
state: British Columbia
city: Vancouver
country: Canada
facility: Downtown IDC
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Windsor
country: Canada
facility: Moncton Hospital
state: New Brunswick
city: Halifax
country: Canada
facility: Victoria General
state: Nova Scotia
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: London
country: Canada
facility: St. Joseph's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook
state: Ontario
city: Toronto
country: Canada
facility: Toronto General
state: Ontario
city: Windsor
country: Canada
facility: Metropolitan Hospital
state: Ontario
city: Montreal
country: Canada
facility: Montreal Chest/Royal-Victoria
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
city: Ste-Foy
country: Canada
facility: Centre Hospitalier Universitaire de Laval
state: Quebec
Study officials:
affiliation: Victoria General Hospital
name: Walter Schlech, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.