Clinical Trials Logo

Clinical Trial Summary

The influenza virus, commonly called the flu, is a common source of infection in lung transplant patients and can often lead to pneumonia and possibly rejection. The annual influenza vaccine is the most important strategy used to prevent infection but it is not effective in all lung transplant patients. It has been thought that the response to the vaccine may be improved if it is given into the skin (intradermal) rather than the muscle (intramuscular). We hypothesize that a significantly greater proportion of patients will respond to vaccination using the intradermal influenza vaccine compared to the intramuscular vaccine.


Clinical Trial Description

The annual influenza vaccine is suggested for immunocompromised patients. However, the immunogenic response to this vaccine is suboptimal and ranges from 15-70%. In lung transplant recipients, responses to the influenza vaccine are poorest of all organ transplant groups. For example, a study with 43 stable lung transplant recipients showed that protective antibody developed in 19%, 30%, and 40% for the three antigens in the vaccine (only 8.6% of subjects developed protective antibody levels against all three). Similarly, 43% responded after a single dose of vaccine was given to 68 lung transplant recipients; response was significantly lower in those on mycophenolate mofetil (MMF). We have recently published a study in 60 lung transplant recipients where the standard influenza vaccine was immunogenic to at least one vaccine antigen in approximately 60% of the patients.

The study we propose is a prospective randomized control trial designed to assess the immunogenicity of the influenza vaccine given intradermally compared to the standard intramuscular vaccine in lung transplant recipients. Lung transplant recipients are unique in that their vaccine responses are the lowest of all organ groups and they stand to benefit most from an alternate vaccine strategy.

CLINICAL SIGNIFICANCE OF THE STUDY Lung transplant recipients appear to have one of the poorest humoral responses to influenza vaccination of all the organ transplant groups. However, influenza remains an important cause of morbidity in this population in whom protection is imperative. The current vaccine is suboptimal and newer strategies need to be studied to increase response rates. This subject area is of critical importance to study and especially in light of the threat of pandemic influenza.

OBJECTIVE AND HYPOTHESIS

- To test the specific humoral and cellular response after the intradermal influenza vaccine.

- To test the safety of the intradermal influenza vaccine in the lung transplant population.

- We hypothesize that a significantly greater proportion of patients will respond to vaccination using the intradermal influenza vaccine compared to the intramuscular vaccine. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00760175
Study type Interventional
Source University of Alberta
Contact
Status Completed
Phase N/A
Start date October 2008
Completion date February 2010

See also
  Status Clinical Trial Phase
Not yet recruiting NCT03285997 - A Study to Evaluate the Efficacy and Safety of GC3110A in Healthy Infants From 6 Months to 35 Months of Age Phase 3
Recruiting NCT05996549 - Cost-effectiveness of the Influenza Vaccination Phase 4
Completed NCT04546854 - Influenza 2020/2021 N/A
Completed NCT05157425 - Effect of a Multi-strain Probiotic Formulation on Immune Response to Influenza Vaccination N/A
Completed NCT01687517 - Efficacy and Safety of Influenza Vaccine During Sarcoidosis Phase 3
Completed NCT01180699 - Intradermal Versus Intramuscular Trivalent Influenza Vaccine in Adult Solid Organ Transplant Recipients N/A
Completed NCT00542776 - Impact of Immunosuppression in IBD Patients on Response to Influenza Vaccine N/A
Completed NCT06304038 - Cost-consequence Analysis of Influenza Vaccination in a Teaching Hospital in Rome
Recruiting NCT04086628 - Influenza Vaccine in Children With Asthma
Completed NCT02960815 - Imiquimod and Influenza Vaccine for Immunocompromised Patients Phase 2
Completed NCT00828555 - Effectiveness of a Vaccination Program in the Community Ob/Gyn Setting N/A
Completed NCT04230343 - Limits of the Social Benefit Motive Among High-risk Patients: a Field Experiment on Influenza Vaccination Behaviour N/A
Recruiting NCT03399357 - Evaluation of Metabolic Predictors of Influenza Vaccine Immune Response in the Singapore Elderly Population - the DYNAMIC Trial N/A
Completed NCT02153671 - Immunogenicity of H5N1 Vaccine Following H5N2 Phase 2
Completed NCT00461981 - A Phase 2 Study to Evaluate Immune Responses of FluMist® Phase 2
Recruiting NCT05070494 - Efficacy of Different Doses of Influenza Vaccine in Chronic Hemodialysis Patients Phase 4
Completed NCT04785794 - Safety and Immunogenicity of the Sing2016 M2SR H3N2 Monovalent Influenza Vaccine in Adults Ages 50 to 85 Years Old Phase 1
Completed NCT05163847 - Safety and Immunogenicity of Cam2020 M2SR H3N2 Monovalent Influenza Vaccine Alone or With Licensed IIV in Older Adults Phase 1
Not yet recruiting NCT04355806 - Impact of Inactivated Trivalent Influenza Vaccine on NSCLC Patients Receiving PD-1 / PD-L1 Inhibitors
Completed NCT01368796 - Comparison of 4 Influenza Vaccines in Seniors Phase 4