Intradermal Versus Intramuscular Trivalent Influenza Vaccine in Adult Solid Organ Transplant Recipients
This study has been completed.
Sponsor:
University of Alberta
Information provided by (Responsible Party):
Deepali Kumar, University of Alberta
ClinicalTrials.gov Identifier:
NCT01180699
First received: June 10, 2010
Last updated: May 26, 2015
Last verified: May 2015
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention |
|---|---|
|
Influenza Vaccine |
Biological: Influenza vaccine: Vaxigrip or Fluviral and Intanza |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention |
| Official Title: | A Randomized Controlled Trial Comparing Intradermal vs. Intramuscular Trivalent Inactivated Influenza Vaccine in Adult Solid Organ Transplant Recipients |
Resource links provided by NLM:
Further study details as provided by University of Alberta:
Primary Outcome Measures:
- Seroconversion rate: serological response with a four-fold or greater increase in HI antibody titers to an antigen [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Local and systemic adverse events to vaccination [ Time Frame: 24 hours, 48 hours and 7 days after each vaccination ] [ Designated as safety issue: Yes ]
| Enrollment: | 229 |
| Study Start Date: | October 2010 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 59 Years (Adult) |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180699
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180699
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 History of Changes |
| Other Study ID Numbers: | KUOA-02 |
| Study First Received: | June 10, 2010 |
| Last Updated: | May 26, 2015 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by 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 Vaccines Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 23, 2016