Early Versus Delayed Pneumococcal Vaccination in HIV

Phase 1

Completed

• Conditions: Pneumococcal Infections
• Interventions: Biological: Pneumovax; Biological: Prevnar

• Registration Number: NCT00137605
• Lead Sponsor: CIHR Canadian HIV Trials Network

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 Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-08-26
• Study First Submitted QC: 2005-08-29
• Study First Posted: 2005-08-30
• Study Completion: 2007-10
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-11
• Last Update Posted: 2014-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Pneumovax/immediate	Pneumovax	-
Pneumovax/delayed	Pneumovax	-
Prevnar/immediate	Prevnar	-
Prevnar/delayed	Prevnar	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Adverse events
Antibody response at 6 months and one year
Changes in viral load 3 months post immunization
Overall incidence of invasive pneumococcal disease
Incidence of invasive pneumococcal disease between vaccines

Trial Locations

Locations (14)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada

Centre Hospitalier Universitaire de Laval; 🇨🇦 Ste-Foy, Quebec, Canada

St. Boniface General Hospital; 🇨🇦 Winnipeg, Manitoba, Canada

Medical Arts Health Research Group; 🇨🇦 Kelowna, British Columbia, Canada

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Downtown IDC; 🇨🇦 Vancouver, British Columbia, Canada

Moncton Hospital; 🇨🇦 Windsor, New Brunswick, Canada

Sunnybrook; 🇨🇦 Toronto, Ontario, Canada

Victoria General; 🇨🇦 Halifax, Nova Scotia, Canada

St. Joseph's Hospital; 🇨🇦 London, Ontario, Canada

Toronto General; 🇨🇦 Toronto, Ontario, Canada

Centre Hospitalier Universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada

Metropolitan Hospital; 🇨🇦 Windsor, Ontario, Canada

Montreal Chest/Royal-Victoria; 🇨🇦 Montreal, Quebec, Canada