Early Versus Delayed Pneumococcal Vaccination in HIV - Full Text View

Sponsors and Collaborators:	Canadian HIV Trials Network Wyeth
Information provided by:	Canadian HIV Trials Network
ClinicalTrials.gov Identifier:	NCT00137605

Purpose

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.

Condition	Intervention	Phase
Pneumococcal Infections	Biological: Pneumovax or Pneumo23 Biological: Prevnar	Phase I Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Official Title:	A Pilot Study Assessing the Efficacy of Pneumococcal Vaccine in HIV Patients: Delayed Versus Immediate Immunization

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Further study details as provided by Canadian HIV Trials Network:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	80
Study Start Date:	April 2003

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137605

Contacts

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

Locations

Canada, British Columbia
Downtown IDC	Recruiting
Vancouver, British Columbia, Canada
Contact 604-642-6429
Principal Investigator: Brian Conway, MD
St. Paul's Hospital	Recruiting
Vancouver, British Columbia, Canada
Contact 604-806-8036
Principal Investigator: Julio Montaner, MD
Medical Arts Health Research Group	Recruiting
Kelowna, British Columbia, Canada, V1Y 1T2
Contact: Dwight Ferris, MD 250-862-4157
Principal Investigator: Dwight AN Ferris, MD
Canada, Manitoba
St. Boniface General Hospital	Recruiting
Winnipeg, Manitoba, Canada
Contact 204-237-2948
Principal Investigator: Stuart Rosser, MD
Canada, New Brunswick
Moncton Hospital	Recruiting
Windsor, New Brunswick, Canada
Contact 506-857-5593
Principal Investigator: Gordon Dow, MD
Canada, Nova Scotia
Victoria General	Recruiting
Halifax, Nova Scotia, Canada
Contact 902-473-5553
Principal Investigator: Walter Schlech, MD
Canada, Ontario
Metropolitan Hospital	Recruiting
Windsor, Ontario, Canada
Contact 519-254-6115
Principal Investigator: Corinna Quan, MD
Sunnybrook	Recruiting
Toronto, Ontario, Canada
Contact 416-480-4689
Principal Investigator: Anita Rachlis, MD
McMaster University	Recruiting
Hamilton, Ontario, Canada
Contact 905-521-9800
Principal Investigator: Fiona Smaill, MD
St. Joseph's Hospital	Recruiting
London, Ontario, Canada
Contact 519-646-6207
Principal Investigator: William Thompson, MD
Toronto General	Recruiting
Toronto, Ontario, Canada
Contact 416-340-3871
Principal Investigator: Sharon Walmsley, MD
Canada, Quebec
Centre Hospitalier Universitaire de Laval	Recruiting
Ste-Foy, Quebec, Canada
Contact 418-654-2705
Principal Investigator: Sylvie Trottier, MD
Centre Hospitalier Universitaire de Sherbrooke	Recruiting
Sherbrooke, Quebec, Canada
Contact 819-564-5321
Principal Investigator: Alain Piché, MD
Montreal Chest/Royal-Victoria	Recruiting
Montreal, Quebec, Canada
Contact 514-843-2090
Principal Investigator: Richard Lalonde, MD

Sponsors and Collaborators

Canadian HIV Trials Network

Wyeth

Investigators

Principal Investigator:

Walter Schlech, MD

Victoria General Hospital

More Information

Additional Information:

Canadian HIV Trials Database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CTN 147, Control # 078760, File # 9427-C1574-34C
Study First Received:	August 26, 2005
Last Updated:	September 7, 2006
ClinicalTrials.gov Identifier:	NCT00137605 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Canadian HIV Trials Network:

HIV
HIV Infections

Study placed in the following topic categories:

Bacterial Infections
Gram-Positive Bacterial Infections
Streptococcal Infections

HIV Infections
Acquired Immunodeficiency Syndrome
Pneumococcal Infections

Additional relevant MeSH terms:

Bacterial Infections
Gram-Positive Bacterial Infections
Streptococcal Infections
Infection
Pneumococcal Infections

ClinicalTrials.gov processed this record on July 06, 2009