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OpenTrials
Completed

NCT Number: NCT01254955

Antibody Production Following H1N1 Influenza Vaccination in Organ Transplant Patients

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.

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Key information

Conditions

Organ Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Transplant Institute, Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, 413 45, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

H1N1 vaccine Pandemrix

Biological

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

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 7, 2010
Registry last updated
Jan 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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