Antibody Production Following H1N1 Influenza Vaccination in Organ Transplant Patients
Organ transplant patients and staff members at the Transplant Institute have received pandemic H1N1 influenza vaccine (Pandemrix) and specific antibody production was measured by haemagglutination inhibition according to the clinical guidelines and policy, respectively. This study retrospectively assessed the immune response after vaccination.
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Antibody Production Following H1N1 Influenza Vaccination in Organ Transplant Patients|
- Frequency of responders in organ transplant patients and controls
- Frequency of >4-fold titre rise in organ transplant patients and controls
|Study Start Date:||October 2009|
|Study Completion Date:||August 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
|organ transplant patients||Biological: H1N1 vaccine Pandemrix|
|healthy controls||Biological: H1N1 vaccine Pandemrix|
A total of 100 organ transplant patients and 36 healthy controls were included in the study. All individuals were vaccinated between October and November 2009 and received 2 doses of Pandemrix. Serum samples were collected at baseline before vaccination and 1 month after the first and second vaccination. Individual hemagglutination-inhibiting serum antibody titers were measured.Frequency of > 4 -fold increase in antibody titers and seroconversion from non-protective prevaccination titers to protective postvaccination titers were recorded. Adverse events were reported.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01254955
|Transplant Institute, Sahlgrenska University Hospital|
|Gothenburg, Västra Götaland, Sweden, 413 45|