Immunogenicity of pneumococcal vaccine in liver transplant recipients
| ISRCTN | ISRCTN07731234 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07731234 |
| ClinicalTrials.gov number | NCT00152802 |
| Secondary identifying numbers | 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
Scientific
University of Alberta Hospital
8440 112th Street, 2E4.16 WMC
Edmonton, Alberta
T6G 2B7
Canada
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Prevention |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/01/2005 |
| Completion date | 28/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
T6G 2B7
Canada
Sponsor information
University Health Network (Canada)
Hospital/treatment centre
Hospital/treatment centre
Toronto General Hospital
585 University Ave
Toronto, Ontario
M5G 2N2
Canada
| Website | http://www.uhn.ca/index.htm |
|---|---|
"ROR" |
https://ror.org/042xt5161 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-79196)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
