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Adjuvanted Influenza Vaccine in Stem Cell Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02560909
Recruitment Status : Completed
First Posted : September 25, 2015
Last Update Posted : April 10, 2017
Information provided by (Responsible Party):
Deepali Kumar, University Health Network, Toronto

Brief Summary:
Influenza virus is an important cause of morbidity in the transplant population and can lead to viral and bacterial pneumonia. Although the annual influenza vaccine is recommended for transplant patients, studies have shown that nonadjuvanted vaccine has poor immunogenicity. There are no studies that define the effect of adjuvanted vaccine in this population. The purpose of this study is to determine if a vaccination with FLUAD® results in improved immunogenicity as compared to standard vaccine in allo-HSCT recipients. Immunogenicity will be assessed by standard quantitative antibody titer assessments and using cell-mediated immunity measurements.

Condition or disease Intervention/treatment Phase
Transplantation Influenza Vaccines Biological: FLUAD® influenza vaccine Biological: FLUVIRAL® Phase 4

Detailed Description:

The investigators plan to study the immunogenicity of two different types of the influenza vaccine in 240 allogeneic stem cell transplant patients during the 2015-2016 season. Patients will be randomized to receive either adjuvanted influenza vaccine or nonadjuvanted. Antibody titers will be evaluated by a standard hemagglutination inhibition assay. The investigators hypothesize that the patients who receive the adjuvanted influenza vaccine will reach significantly 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 adjuvanted influenza vaccine is successful, this strategy may lead to a significant reduction in burden of disease, hospitalizations, and long-term morbidity.

The co-administration of vaccine with an adjuvant is a potentially promising method of boosting immunogenicity. Two adjuvants have been used in influenza vaccines: AS03 and MF59. Both are oil-in-water emulsions. AS03 was used in the monovalent pandemic A/H1N1 vaccine in Canada and Europe. Adjuvanted vaccines have been studied in the hematopoietic stem cell transplant population with most studies done in using the AS03-adjuvanted pandemic vaccine. MF59 adjuvant has been used in seasonal influenza vaccine in Canada and Europe for people ≥65 years old. MF59-adjuvanted vaccines have not been well studied in hematopoietic stem cell transplantation but could represent a significant advance if they show greater immunogenicity than the standard non-adjuvanted influenza vaccine. Both FLUAD® and the standard 2015-2016 nonadjuvanted vaccine will contain 15 microgram antigen from each strain and will be injected in a standard dose (0.5 mL) in the deltoid muscle by trained personnel.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial Comparing Adjuvanted vs. Nonadjuvanted Influenza Vaccine in Adult Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients.
Actual Study Start Date : October 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Experimental
The experimental group will receive one dose MF59 adjuvanted intramuscular vaccine.
Biological: FLUAD® influenza vaccine
MF59 adjuvant has been used in seasonal influenza vaccine in Canada and Europe for people ≥65 years. MF59 contains squalene, polysorbate 80, and sorbitan trioleate. It is packaged as small microvesicles of 160nm diameter. The complete mechanism of action of MF59 is not well understood but requires activation of the innate immune system; the adjuvant exerts a local inflammatory response increasing the influx of neutrophils and macrophages to the injection site.
Other Name: MF59 adjuvanted vaccine

Active Comparator: Control
The control group will receive one dose of the standard 2015-2016 nonadjuvanted vaccine.
Biological: FLUVIRAL®
Standard 2015-2016 nonadjuvanted vaccine
Other Name: Trivalent Influenza Vaccine

Primary Outcome Measures :
  1. Rates of seroconversion [ Time Frame: 4 weeks from vaccination ]
    serological response with a four-fold or greater increase in HI antibody titers to an antigen

Secondary Outcome Measures :
  1. Rates of seroprotection [ Time Frame: 4 weeks from vaccination ]
    HIA titers of >=1:40

  2. Rate of Local and systemic adverse events to vaccination [ Time Frame: within 7 days of vaccination ]
  3. Number of participants with microbiologically-documented influenza infection [ Time Frame: 6 months from vaccination ]
    confirmed by direct fluorescent antibody, viral culture, or PCR

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age ≥ 18
  • Greater than 3 months post-transplant
  • Allogeneic HSCT

Exclusion Criteria:

  • Has already received influenza vaccination for 2015-2016 season
  • Egg allergy
  • Previous life-threatening reaction to influenza vaccine (i.e. Guillain Barre Syndrome)
  • Febrile illness in the past one week
  • Receipt of intravenous immunoglobulin (IVIG) in the past 30 days or planning to receive IVIG in the next 4 weeks
  • Unable to provide informed consent
  • Unable to comply with study protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02560909

Sponsors and Collaborators
University Health Network, Toronto
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Principal Investigator: Deepali Kumar, MD University Health Network, Toronto

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Responsible Party: Deepali Kumar, Physician, Transplant Infectious Diseases, University Health Network, Toronto Identifier: NCT02560909     History of Changes
Other Study ID Numbers: 15-9503
First Posted: September 25, 2015    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs