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Antibody Production Following H1N1 Influenza Vaccination in Organ Transplant Patients

S

Sahlgrenska University Hospital

Status

Completed

Conditions

Organ Transplantation

Treatments

Biological: H1N1 vaccine Pandemrix

Study type

Observational

Funder types

Other

Identifiers

NCT01254955
ALFGBG-141031

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

0 participants in 2 patient groups

organ transplant patients
Treatment:
Biological: H1N1 vaccine Pandemrix
healthy controls
Treatment:
Biological: H1N1 vaccine Pandemrix

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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