Antibody Production Following H1N1 Influenza Vaccination in Organ Transplant Patients

Organ Transplantation Clinical Trial

Official title:

Antibody Production Following H1N1 Influenza Vaccination in Organ Transplant Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254955
• Other study ID #: ALFGBG-141031
• Status: Completed
• Phase: N/A
• First received: December 6, 2010
• Last updated: January 13, 2012
• Start date: October 2009
• Est. completion date: August 2011

Study information

• Verified date: January 2012
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Organ Transplantation

Intervention

Biological:
• H1N1 vaccine Pandemrix

Locations

Country	Name	City	State
Sweden	Transplant Institute, Sahlgrenska University Hospital	Gothenburg	Västra Götaland

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of responders in organ transplant patients and controls
Secondary	Frequency of >4-fold titre rise in organ transplant patients and controls