Antibody Production Following H1N1 Influenza Vaccination in Organ Transplant Patients

January 13, 2012 updated by: Vanda Friman, Sahlgrenska University Hospital, Sweden
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Västra Götaland
      • Gothenburg, Västra Götaland, Sweden, 413 45
        • Transplant Institute, Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Tranplant patients at the out-patient clinical ward and staff members at the Transplant Institute, Sahlgrenska University Hospital.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
healthy controls
Biological: H1N1 vaccine Pandemrix
organ transplant patients
Biological: H1N1 vaccine Pandemrix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Frequency of responders in organ transplant patients and controls

Secondary Outcome Measures

Outcome Measure
Frequency of >4-fold titre rise in organ transplant patients and controls

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

December 6, 2010

First Submitted That Met QC Criteria

December 6, 2010

First Posted (Estimate)

December 7, 2010

Study Record Updates

Last Update Posted (Estimate)

January 16, 2012

Last Update Submitted That Met QC Criteria

January 13, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALFGBG-141031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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