Early Versus Delayed Pneumococcal Vaccination in HIV

Pneumococcal Infections Clinical Trial

Official title:

A Pilot Study Assessing the Efficacy of Pneumococcal Vaccine in HIV Patients: Delayed Versus Immediate Immunization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00137605
• Other study ID #: CTN 147
• Secondary ID: Control # 078760
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 26, 2005
• Last updated: February 11, 2014
• Start date: September 2004
• Est. completion date: October 2007

Study information

• Verified date: February 2014
• Source: CIHR Canadian HIV Trials Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pneumococcal Infections

Intervention

Biological:
• Pneumovax

• Prevnar

Locations

Country	Name	City	State
Canada	Victoria General	Halifax	Nova Scotia
Canada	McMaster University	Hamilton	Ontario
Canada	Medical Arts Health Research Group	Kelowna	British Columbia
Canada	St. Joseph's Hospital	London	Ontario
Canada	Montreal Chest/Royal-Victoria	Montreal	Quebec
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	Centre Hospitalier Universitaire de Laval	Ste-Foy	Quebec
Canada	Sunnybrook	Toronto	Ontario
Canada	Toronto General	Toronto	Ontario
Canada	Downtown IDC	Vancouver	British Columbia
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	Metropolitan Hospital	Windsor	Ontario
Canada	Moncton Hospital	Windsor	New Brunswick
Canada	St. Boniface General Hospital	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
CIHR Canadian HIV Trials Network	Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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):2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of serotypes to which a response is found
Primary	A response is defined as a doubling in antibody titer at 1 month compared to baseline.
Secondary	Antibody response at 6 months and one year
Secondary	Changes in viral load 3 months post immunization
Secondary	Adverse events
Secondary	Overall incidence of invasive pneumococcal disease
Secondary	Incidence of invasive pneumococcal disease between vaccines