Early Versus Delayed Pneumococcal Vaccination in HIV - Tabular View

Tracking Information

First Received Date ^ICMJE

August 26, 2005

Last Updated Date

September 7, 2006

Start Date ^ICMJE

April 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

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

Complete list of historical versions of study NCT00137605 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

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

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 Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study

Condition ^ICMJE

Pneumococcal Infections

Intervention ^ICMJE

Biological: Pneumovax or Pneumo23
Biological: Prevnar

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Deborah Kraus, RN	604-806-9431
Contact: Don Zarowny	604-806-8378

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00137605

Responsible Party

Study ID Numbers ^ICMJE

CTN 147, Control # 078760, File # 9427-C1574-34C

Study Sponsor ^ICMJE

Canadian HIV Trials Network

Collaborators ^ICMJE

Wyeth

Investigators ^ICMJE

Principal Investigator:

Walter Schlech, MD

Victoria General Hospital

Information Provided By

Canadian HIV Trials Network

Verification Date

September 2006

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