Antibody Levels Against 2009 Influenza A H1N1 One Year After Vaccination With Pandemrix and 2010 Fluarix Booster in Organ Transplant Recipients.

Overview

Organ transplant patients who participated in a retrospective study and received 2009 Pandemrix vaccine during autumn 2009 are included in this study. The main aim is to determine the H1N1 antibody levels one year after Pandemrix in comparison to healthy controls. The secondary aim is to examine the booster effect of 2010 Fluarix in patients and controls.Side effects to Fluarix vaccine are registered.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective

Detailed Description

Organ transplant patients and staff members of the Transplant Institute who were vaccinated 2009 and received 2 doses of 2009 H1N1 influenza vaccine (Pandemrix) will be asked to participate in the study. Serum samples will be collected approximately one year after completed vaccination with Pandemrix and analysed for haemagglutination -inhibiting antibodies against H1N1.The frequency of individuals with remaining protective titers will be examined. The same individuals will be vaccinated with Fluarix containing antigen from Influenza A California/7/2009(H1N1, A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008. The booster effect will be measured one month later.

Arms, Groups and Cohorts

  • organ transplant patients
  • healthy controls

Clinical Trial Outcome Measures

Primary Measures

  • Frequency of individuals with remaining protective antibody titers against influenza H1N1 2009 one year after Pandemrix vaccination in organ transplant patients and controls
    • Time Frame: 4 months

Secondary Measures

  • Booster effect on antibody titers against influenza 2009 H1N1 of 2010 Fluarix vaccination
    • Time Frame: February 2011

Participating in This Clinical Trial

Inclusion Criteria Cohort number 1: Organ transplant patients who were vaccinated with Pandemrix 2009 and written informed consent received Cohort number 2: Staff members who were vaccinated with Pandemrix 2009 and written informed consent received Exclusion Criteria:

Patients or controls who are allergic to formaldehyde, gentamycin sulphate or natrium deoxycholate or have other contraindications against to Fluarix vaccination.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Sahlgrenska University Hospital, Sweden
  • Provider of Information About this Clinical Study
    • Associate Professor Vanda Friman, Sahlgrenska University Hospital
  • Overall Official(s)
    • Vanda Friman, MD, Ph.D, Principal Investigator, Sahlgrenska University Hospital, Sweden
  • Overall Contact(s)
    • Marie Felldin, MD, +46 31342 10 00, marie.felldin@vgregion.se

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