Organ Transplantation
Conditions
Keywords
2009 H1N1 influenza vaccine, organ transplant patients
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALH1N1 vaccine Pandemrix
Sponsors
Sahlgrenska University Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Cohort number 1:Organ transplant patients who were vaccinated and serum sample drawn at baseline. Cohort number 2: Staff members who were vaccinated and serum sample drawn at baseline.
Exclusion criteria
Cohort number 1: Organ transplant patients who were vaccinated and no serum sample drawn at baseline. Cohort number 2: Staff members who were vaccinated and no serum sample drawn at baseline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of responders in organ transplant patients and controls | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of >4-fold titre rise in organ transplant patients and controls | — |
Countries
Sweden
Outcome results
None listed