Early Versus Delayed Pneumococcal Vaccination in HIV - Full Text View

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

MedlinePlus related topics:

AIDS

ChemIDplus related topics:

Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

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

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

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

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

Infection

ClinicalTrials.gov processed this record on October 15, 2008

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