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

• ClinicalTrials.gov Identifier: NCT01180699
• Recruitment Status: Completed
• First Posted: August 12, 2010
• Last Update Posted: May 27, 2015
• Sponsor: University of Alberta
• Information provided by (Responsible Party): Deepali Kumar, University of Alberta

Tracking Information

• First Submitted Date: June 10, 2010
• First Posted Date: August 12, 2010
• Last Update Posted Date: May 27, 2015
• Study Start Date: October 2010
• Actual Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 10, 2010): Seroconversion rate: serological response with a four-fold or greater increase in HI antibody titers to an antigen [ Time Frame: 4 weeks ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: August 10, 2010): Local and systemic adverse events to vaccination [ Time Frame: 24 hours, 48 hours and 7 days after each vaccination ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Intradermal Versus Intramuscular Trivalent Influenza Vaccine in Adult Solid Organ Transplant Recipients
• Official Title: A Randomized Controlled Trial Comparing Intradermal vs. Intramuscular Trivalent Inactivated Influenza Vaccine in Adult Solid Organ Transplant Recipients
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Prevention
• Condition: Influenza Vaccine

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.

Study Arms

• Experimental: influenza vaccine - intradermal
  intradermal versus intramuscular
  Intervention: Biological: Influenza vaccine: Vaxigrip or Fluviral and Intanza
• Active Comparator: influenza vaccine - intramuscular
  Intervention: Biological: Influenza vaccine: Vaxigrip or Fluviral and Intanza

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 26, 2015): 229
• Original Estimated Enrollment (submitted: August 10, 2010): 200
• Actual Study Completion Date: December 2012
• Actual Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 59 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT01180699
• Other Study ID Numbers: KUOA-02
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Deepali Kumar, University of Alberta
• Study Sponsor: University of Alberta
• Collaborators: Not Provided

Investigators

• Principal Investigator: Deepali Kumar; University of Alberta

• PRS Account: University of Alberta
• Verification Date: May 2015