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Antibody Production Following H1N1 Influenza Vaccination in Organ Transplant Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01254955
First Posted: December 7, 2010
Last Update Posted: January 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Vanda Friman, Sahlgrenska University Hospital, Sweden
  Purpose
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.

Condition Intervention
Organ Transplantation Biological: H1N1 vaccine Pandemrix

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Antibody Production Following H1N1 Influenza Vaccination in Organ Transplant Patients

Resource links provided by NLM:


Further study details as provided by Vanda Friman, Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • Frequency of responders in organ transplant patients and controls

Secondary Outcome Measures:
  • 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)
Groups/Cohorts Assigned Interventions
organ transplant patients Biological: H1N1 vaccine Pandemrix
healthy controls Biological: H1N1 vaccine Pandemrix

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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Tranplant patients at the out-patient clinical ward and staff members at the Transplant Institute, Sahlgrenska University Hospital.
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01254955


Locations
Sweden
Transplant Institute, Sahlgrenska University Hospital
Gothenburg, Västra Götaland, Sweden, 413 45
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
  More Information

Publications:
Responsible Party: Vanda Friman, MD, PhD, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01254955     History of Changes
Other Study ID Numbers: ALFGBG-141031
First Submitted: December 6, 2010
First Posted: December 7, 2010
Last Update Posted: January 16, 2012
Last Verified: January 2012

Keywords provided by Vanda Friman, Sahlgrenska University Hospital, Sweden:
2009 H1N1 influenza vaccine, organ transplant patients

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Antibodies
Immunologic Factors
Physiological Effects of Drugs