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

Influenza Vaccine Clinical Trial

Official title:

A Randomized Controlled Trial Comparing Intradermal vs. Intramuscular Trivalent Inactivated Influenza Vaccine in Adult Solid Organ Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01180699
• Other study ID #: KUOA-02
• Status: Completed
• Phase: N/A
• First received: June 10, 2010
• Last updated: May 26, 2015
• Start date: October 2010
• Est. completion date: December 2012

Study information

• Verified date: May 2015
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: December 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 59 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Influenza Vaccine
• Influenza, Human

Intervention

Biological:
• Influenza vaccine: Vaxigrip or Fluviral and Intanza
Patients will be randomized to receive either one intradermal dose of 0.1 mL or one intramuscular injection of 0.5 mL of the standard influenza vaccine in the deltoid muscle of the nondominant arm.

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroconversion rate: serological response with a four-fold or greater increase in HI antibody titers to an antigen		4 weeks	Yes
Secondary	Local and systemic adverse events to vaccination		24 hours, 48 hours and 7 days after each vaccination	Yes