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Completed

NCT Number: NCT01180699

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

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.

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Key information

Conditions

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

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta Hospital

Edmonton, Alberta, T6G 2E1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Influenza vaccine: Vaxigrip or Fluviral and Intanza

Biological

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.

Primary outcomes

  1. Seroconversion rate: serological response with a four-fold or greater increase in HI antibody titers to an antigen

    Time frame: 4 weeks

Secondary outcomes

  1. Local and systemic adverse events to vaccination

    Time frame: 24 hours, 48 hours and 7 days after each vaccination

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 12, 2010
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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