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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Influenza Vaccine	Biological: Influenza vaccine: Vaxigrip or Fluviral and Intanza	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 229 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: A Randomized Controlled Trial Comparing Intradermal vs. Intramuscular Trivalent Inactivated Influenza Vaccine in Adult Solid Organ Transplant Recipients
• Study Start Date: October 2010
• Actual Primary Completion Date: August 2012
• Actual Study Completion Date: December 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: influenza vaccine - intradermal; intradermal versus intramuscular	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.
Active Comparator: influenza vaccine - intramuscular	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.

Outcome Measures

Primary Outcome Measures :

1. Seroconversion rate: serological response with a four-fold or greater increase in HI antibody titers to an antigen [ Time Frame: 4 weeks ]

Secondary Outcome Measures :

1. Local and systemic adverse events to vaccination [ Time Frame: 24 hours, 48 hours and 7 days after each vaccination ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 59 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Canada, Alberta

University of Alberta Hospital

Edmonton, Alberta, Canada, T6G 2E1

Sponsors and Collaborators

University of Alberta

Investigators

• Principal Investigator: Deepali Kumar; University of Alberta

More Information

• Responsible Party: Deepali Kumar, Assistant Professor of Medicine, University of Alberta
• ClinicalTrials.gov Identifier: NCT01180699
• Other Study ID Numbers: KUOA-02
• First Posted: August 12, 2010
• Last Update Posted: May 27, 2015
• Last Verified: May 2015

Keywords provided by Deepali Kumar, University of Alberta:

adult solid organ transplant patients

Additional relevant MeSH terms:

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