Intradermal Versus Intramuscular Trivalent Influenza Vaccine in Adult Solid Organ Transplant Recipients

Not Applicable

Completed

• Conditions: Influenza Vaccine

• Registration Number: NCT01180699
• Lead Sponsor: University of Alberta

Brief Summary

Influenza virus is an important cause of morbidity in the transplant population and can lead to viral and bacterial pneumonia and contribute to the development of rejection. Although the annual influenza vaccine is recommended for transplant patients, studies have shown that a single intramuscular dose has poor immunogenicity. There are no studies that define the effect of intradermal doses in this population. We plan to study the immunogenicity of two different administration routes of the influenza vaccine in 200 solid organ transplant patients during the 2010-2011 season. Patients will be randomized to receive influenza vaccine either intradermally or intramuscularly. We hypothesize that the patients who receive the intradermal influenza vaccine will significantly reach a higher response to the vaccine. This study advances research on the prevention of serious viral infections in transplant recipients. Results from this study have the potential to directly improve patient care. If the use of the intradermal influenza vaccine is successful, this strategy may lead to a significant reduction in burden of disease, hospitalizations, and long-term morbidity.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-10
• Study First Submitted QC: 2010-08-10
• Study First Posted: 2010-08-12
• Study Start: 2010-10
• Primary Completion: 2012-08
• Study Completion: 2012-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 229

Inclusion Criteria

• Age ≥ 18 and ≤ 59,
• Greater than 3 months post-transplant,
• Any solid organ transplant (kidney, liver, heart, lung, pancreas, intestinal or combinations of the aforementioned organs)

Exclusion Criteria

• Has already received influenza vaccination for 2010-2011 season;
• Egg allergy,
• Previous life-threatening reaction to influenza vaccine (i.e. Guillain Barre Syndrome),
• Ongoing therapy for rejection,
• Febrile illness in the past two weeks,
• Unable to provide informed consent,
• Unable to comply with study protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Seroconversion rate: serological response with a four-fold or greater increase in HI antibody titers to an antigen	4 weeks

Secondary Outcome Measures

Name	Time	Method
Local and systemic adverse events to vaccination	24 hours, 48 hours and 7 days after each vaccination

Trial Locations

Locations (1)

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada