Condition category
Infections and Infestations
Date applied
21/05/2008
Date assigned
21/05/2008
Last edited
24/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Deepali Kumar

ORCID ID

Contact details

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

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 measures

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

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

http://www.uhn.ca/index.htm

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

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18715160

Publication citations

  1. 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.

Additional files

Editorial Notes