Immunogenicity of pneumococcal vaccine in liver transplant recipients

ISRCTN	ISRCTN07731234
DOI	https://doi.org/10.1186/ISRCTN07731234
ClinicalTrials.gov (NCT)	NCT00152802
Protocol serial number	MCT-79196
Sponsor	University Health Network (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-79196)

Submission date: 21/05/2008
Registration date: 21/05/2008
Last edited: 24/02/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Deepali Kumar
Scientific

University of Alberta Hospital
8440 112th Street, 2E4.16 WMC
Edmonton, Alberta
T6G 2B7
Canada

Study information

Primary study design	Interventional
Study design	Randomised, double-blind (study participant and investigator), placebo-controlled, safety/efficacy study, single centre trial
Secondary study design	Randomised controlled trial
Scientific title	Immunogenicity of pneumococcal vaccine in liver transplant recipients: a randomised, double-blind, placebo-controlled, safety/efficacy study, single centre trial
Study objectives	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(s)	Research Ethics Board of the University Health Network (Toronto) approved on the 10th September 2004 (ref: 04-0450-123TGH)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Prevnar™, Pneumovax®
Primary outcome measure(s)	Antibody titres to the seven serotypes contained in conjugate vaccine (4, 6B, 9V, 14, 19F, 23F), 16 weeks.
Key secondary outcome measure(s)	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
Completion date	28/02/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	130
Key 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
Key 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
Date of first enrolment	01/01/2005
Date of final enrolment	28/02/2008

Locations

Countries of recruitment

Canada

Study participating centre

University of Alberta Hospital

Edmonton, Alberta
T6G 2B7
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2008		Yes	No