Cell-mediated Immune Response to Influenza Vaccine - Full Text View

Sponsored by:	University of Alberta
Information provided by:	University of Alberta
ClinicalTrials.gov Identifier:	NCT00677547

Purpose

Influenza virus is an important cause of morbidity in the transplant population and can lead to viral and bacterial pneumonia. Although the annual influenza vaccine is recommended for organ transplant patients, studies have shown that the standard inactivated influenza vaccine has poor immunogenicity in this population. One major hurdle in the evaluation of the response of influenza vaccine in immunocompromised patients is the lack of correlation between humoral response and efficacy of the vaccine. In patients with poor immune responses, cellular immunity may have a better correlation than humoral immunity with vaccine protection. We plan to assess the utility of 3 assays that evaluate the cell-mediated immune response (granzyme B, interleukin-10 (IL-10), and interferon-gamma (IFN-)) after influenza vaccine in kidney transplant recipients. Results from this study have the potential to directly improve patient care. The new monitoring assays may more accurately determine the risk for development of influenza infection, and therefore allowing a better prevention strategy.

Condition	Phase
Kidney Transplant	Phase I

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Humoral and Cell-mediated Immune Response to Influenza Vaccine in Kidney Tranpslant Recipients.

Resource links provided by NLM:

MedlinePlus related topics: Flu Kidney Transplantation

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Further study details as provided by University of Alberta:

Primary Outcome Measures:

Correlation between the levels of Granzyme B and the IFN-/IL-10 ratio and the humoral response (HIA titers of 1:40, or serological response with a four-fold or greater increase in HI antibody titers), in the transplant and the control groups. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Local and systemic adverse events to vaccination. Rates of allograft rejection in the 6 months following vaccination Documented influenza infection (by direct fluorescent antibody, viral culture, or PCR) in the 6 months following vaccination [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	November 2007
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Kidney transplant recipients
2 Healthy volunteers

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Adult kidney transplant recipients and healthy volunteers (enrolled among hospital staff)

Criteria

Adult kidney transplant recipients:

Inclusion Criteria:

Age ≥ 18
Greater than 3 months post-transplant

Exclusion Criteria:

Egg allergy
Previous life-threatening reaction to influenza vaccine (ie Guillain Barre Syndrome)
On anticoagulants such as warfarin that precludes intramuscular injection
Ongoing therapy for rejection
Febrile illness in the past two weeks
Unable to provide informed consent

Healthy volunteers

Inclusion Criteria:

Age ≥ 18

Exclusion Criteria:

Egg allergy
Previous life-threatening reaction to influenza vaccine (ie Guillain Barre Syndrome)
On anticoagulants such as warfarin that precludes intramuscular injection
On immunosuppressive medication (prednisone, immunomodulators for autoimmune diseases)
Underlying autoimmune disease (eg, sarcoid, lupus, rheumatoid arthritis, Crohn's disease)
Febrile illness in the past two weeks
Unable to provide informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677547

Locations

Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G-2E1

Sponsors and Collaborators

University of Alberta

Investigators

Principal Investigator:

Deepali Kumar, MD

University of Alberta Hospital

More Information

Publications:

Ison MG, Hayden FG. Viral infections in immunocompromised patients: what's new with respiratory viruses? Curr Opin Infect Dis. 2002 Aug;15(4):355-67. Review.

Ljungman P, Andersson J, Aschan J, Barkholt L, Ehrnst A, Johansson M, Weiland O. Influenza A in immunocompromised patients. Clin Infect Dis. 1993 Aug;17(2):244-7.

Kumar D, Erdman D, Keshavjee S, Peret T, Tellier R, Hadjiliadis D, Johnson G, Ayers M, Siegal D, Humar A. Clinical impact of community-acquired respiratory viruses on bronchiolitis obliterans after lung transplant. Am J Transplant. 2005 Aug;5(8):2031-6.

Responsible Party:	University of Alberta Hospital ( Dr. Deepali Kumar )
Study ID Numbers:	7061
Study First Received:	May 12, 2008
Last Updated:	August 19, 2009
ClinicalTrials.gov Identifier:	NCT00677547 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by University of Alberta:

Kidney
Influenza vaccine
CMI

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases

Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

ClinicalTrials.gov processed this record on September 10, 2009