Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00152802
Protocol/serial number
MCT-79196
Study information
Scientific title
Immunogenicity of pneumococcal vaccine in liver transplant recipients: a randomised, double-blind, placebo-controlled, safety/efficacy study, single centre trial
Acronym
Study hypothesis
It is hypothesised that the conjugate vaccine priming will provide an enhanced response in these immunosuppressed individuals who may respond poorly to standard vaccination.
Ethics approval
Research Ethics Board of the University Health Network (Toronto) approved on the 10th September 2004 (ref: 04-0450-123TGH)
Study design
Randomised, double-blind (study participant and investigator), placebo-controlled, safety/efficacy study, single centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Pneumococcal vaccination
Intervention
1. The conjugate vaccine used will be Prevnar™ (Wyeth vaccines) 0.5 mL, once, intramuscularly
2. The polysaccharide vaccine Pneumovax® (Merck-Frosst) 0.5 mL, once, intramuscularly (I.M.)
Duration of follow-up = 2 years for all treatment arms
Contact for public queries:
Mr J Blackmore
Research Coordinator
MOT - Clinical Trials
Toronto General Hospital
585 University Ave, NCSB 11C
Toronto ON
M5G 2N2
Canada
Tel: +1 416 340 4800 ext. 4149
Fax: +1 416 595 5013
Email: jeffrey.blackmore@uhn.on.ca
Intervention type
Drug
Phase
Not Applicable
Drug names
Prevnar™, Pneumovax®
Primary outcome measure
Antibody titres to the seven serotypes contained in conjugate vaccine (4, 6B, 9V, 14, 19F, 23F), 16 weeks.
Secondary outcome measures
1. Functional antibody concentration: the titre of functional antibody against the seven pneumococcal serotypes contained in the conjugate vaccine will be determined.
Opsonophagocytic assay will be measured at time 0 and 16 weeks.
2. Adverse reactions: any adverse effects attributed to conjugate or polysaccharide vaccines will be documented. These will include local reactions such as redness, swelling, tenderness and systemic reactions such as fever.
3. Invasive pneumococcal disease: any occurrence of documented pneumococcal disease in vaccinated patients will be recorded
Overall trial start date
01/01/2005
Overall trial end date
28/02/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Male or female outpatients who fulfill the following criteria will be eligible for the study:
1. Liver transplant recipients greater than three months post-transplant
2. No prior pneumococcal vaccination within the last five years
3. Stable allograft function as evidenced by a alanine aminotransferase less than 10 times the upper limit of normal (umol/L) that is not worsening
4. Able to provide written informed consent and comply with study protocol
5. Aged greater than 16 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
130
Participant exclusion criteria
1. Unable to provide informed consent or comply with protocol
2. Prior pneumococcal vaccination within five years of enrolment
3. Splenectomy
4. Admitted to hospital for acute illness
5. Febrile illness in the past two weeks
6. Intravenous immunoglobulin in the last six months
7. Current episode of allograft rejection
8. Currently on full-dose anticoagulation as a contraindication to intramuscular injection
Recruitment start date
01/01/2005
Recruitment end date
28/02/2008
Locations
Countries of recruitment
Canada
Trial participating centre
University of Alberta Hospital
Edmonton, Alberta
T6G 2B7
Canada
Sponsor information
Organisation
University Health Network (Canada)
Sponsor details
Toronto General Hospital
585 University Ave
Toronto
Ontario
M5G 2N2
Canada
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-79196)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18715160
Publication citations
-
Results
Kumar D, Chen MH, Wong G, Cobos I, Welsh B, Siegal D, Humar A, A randomized, double-blind, placebo-controlled trial to evaluate the prime-boost strategy for pneumococcal vaccination in adult liver transplant recipients., Clin. Infect. Dis., 2008, 47, 7, 885-892, doi: 10.1086/591537.