Antibody Production Following H1N1 Influenza Vaccination in Organ Transplant Patients

Completed

• Conditions: Organ Transplantation
• Interventions: Biological: H1N1 vaccine Pandemrix

• Registration Number: NCT01254955
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-12-06
• Study First Submitted QC: 2010-12-06
• Study First Posted: 2010-12-07
• Primary Completion: 2011-01
• Study Completion: 2011-08
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-13
• Last Update Posted: 2012-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
organ transplant patients	H1N1 vaccine Pandemrix	-
healthy controls	H1N1 vaccine Pandemrix	-

Primary Outcome Measures

Name	Time	Method
Frequency of responders in organ transplant patients and controls

Secondary Outcome Measures

Name	Time	Method
Frequency of >4-fold titre rise in organ transplant patients and controls

Trial Locations

Locations (1)

Transplant Institute, Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Västra Götaland, Sweden