Adjuvanted Influenza Vaccine in Stem Cell Transplant
Primary Purpose
Transplantation, Influenza Vaccines
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
FLUAD® influenza vaccine
FLUVIRAL®
Sponsored by
About this trial
This is an interventional prevention trial for Transplantation
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
Control
Arm Description
The experimental group will receive one dose MF59 adjuvanted intramuscular vaccine.
The control group will receive one dose of the standard 2015-2016 nonadjuvanted vaccine.
Outcomes
Primary Outcome Measures
Rates of seroconversion
serological response with a four-fold or greater increase in HI antibody titers to an antigen
Secondary Outcome Measures
Rates of seroprotection
HIA titers of >=1:40
Rate of Local and systemic adverse events to vaccination
Number of participants with microbiologically-documented influenza infection
confirmed by direct fluorescent antibody, viral culture, or PCR
Full Information
NCT ID
NCT02560909
First Posted
September 3, 2015
Last Updated
April 6, 2017
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT02560909
Brief Title
Adjuvanted Influenza Vaccine in Stem Cell Transplant
Official Title
A Randomized Controlled Trial Comparing Adjuvanted vs. Nonadjuvanted Influenza Vaccine in Adult Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transplantation, Influenza Vaccines
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
The experimental group will receive one dose MF59 adjuvanted intramuscular vaccine.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The control group will receive one dose of the standard 2015-2016 nonadjuvanted vaccine.
Intervention Type
Biological
Intervention Name(s)
FLUAD® influenza vaccine
Other Intervention Name(s)
MF59 adjuvanted vaccine
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
FLUVIRAL®
Other Intervention Name(s)
Trivalent Influenza Vaccine
Intervention Description
Standard 2015-2016 nonadjuvanted vaccine
Primary Outcome Measure Information:
Title
Rates of seroconversion
Description
serological response with a four-fold or greater increase in HI antibody titers to an antigen
Time Frame
4 weeks from vaccination
Secondary Outcome Measure Information:
Title
Rates of seroprotection
Description
HIA titers of >=1:40
Time Frame
4 weeks from vaccination
Title
Rate of Local and systemic adverse events to vaccination
Time Frame
within 7 days of vaccination
Title
Number of participants with microbiologically-documented influenza infection
Description
confirmed by direct fluorescent antibody, viral culture, or PCR
Time Frame
6 months from vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepali Kumar, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Adjuvanted Influenza Vaccine in Stem Cell Transplant
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