Antibody Production Following H1N1 Influenza Vaccination in Organ Transplant Patients

NCT01254955 | Completed

• 1 other identifier: ALFGBG-141031
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Organ Transplantation

Keywords

2009 H1N1 influenza vaccine, organ transplant patients

Outcome Measures

Primary Outcomes (1)

• Frequency of responders in organ transplant patients and controls

Secondary Outcomes (1)

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

Study Arms (2)

organ transplant patients

Biological: H1N1 vaccine Pandemrix

healthy controls

Biological: H1N1 vaccine Pandemrix

Interventions

H1N1 vaccine Pandemrix BIOLOGICAL

healthy controls; organ transplant patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Transplant Institute, Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, 413 45, Sweden

Location

Related Publications (1)

• Felldin M, Studahl M, Svennerholm B, Friman V. The antibody response to pandemic H1N1 2009 influenza vaccine in adult organ transplant patients. Transpl Int. 2012 Feb;25(2):166-71. doi: 10.1111/j.1432-2277.2011.01391.x. Epub 2011 Nov 26.

  PMID: 22117586 RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 6, 2010
• First Posted: December 7, 2010
• Study Start: October 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: August 1, 2011
• Last Updated: January 16, 2012

Record last verified: 2012-01

Locations

SE (1)