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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Sahlgrenska University Hospital, Sweden.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT01256931
First received: December 7, 2010
Last updated: December 8, 2010
Last verified: December 2010
  Purpose

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.


Condition
Organ Transplantation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Antibody Levels Against 2009 Influenza A H1N1 One Year After Vaccination With Pandemrix and 2010 Fluarix Booster in Organ Transplant Recipients.

Resource links provided by NLM:


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

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Booster effect on antibody titers against influenza 2009 H1N1 of 2010 Fluarix vaccination [ Time Frame: February 2011 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 110
Study Start Date: December 2010
Groups/Cohorts
organ transplant patients
healthy controls

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01256931

Contacts
Contact: Marie Felldin, MD +46 31342 10 00 marie.felldin@vgregion.se

Locations
Sweden
Transplant Institute, Sahlgrenska University Hospital Recruiting
Gothenburg, Västra Götaland, Sweden
Contact: Marie Felldin, MD    +46 31 342 10 00    marie.felldin@vgregion.se   
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
Principal Investigator: Vanda Friman, MD, Ph.D Sahlgrenska University Hospital, Sweden
  More Information

No publications provided by Sahlgrenska University Hospital, Sweden

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Associate Professor Vanda Friman, Sahlgrenska University Hospital
ClinicalTrials.gov Identifier: NCT01256931     History of Changes
Other Study ID Numbers: MMV-305
Study First Received: December 7, 2010
Last Updated: December 8, 2010
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Sahlgrenska University Hospital, Sweden:
2009 H1N1 influenza vaccine, organ transplant patients,
booster with Fluarix

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

ClinicalTrials.gov processed this record on September 11, 2014