Adjuvanted Influenza Vaccine in Stem Cell Transplant
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|ClinicalTrials.gov Identifier: NCT02560909|
Recruitment Status : Completed
First Posted : September 25, 2015
Last Update Posted : April 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Transplantation Influenza Vaccines||Biological: FLUAD® influenza vaccine Biological: FLUVIRAL®||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||73 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
Standard 2015-2016 nonadjuvanted vaccine
Other Name: Trivalent Influenza Vaccine
- 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
- Rates of seroprotection [ Time Frame: 4 weeks from vaccination ]HIA titers of >=1:40
- Rate of Local and systemic adverse events to vaccination [ Time Frame: within 7 days of vaccination ]
- Number of participants with microbiologically-documented influenza infection [ Time Frame: 6 months from vaccination ]confirmed by direct fluorescent antibody, viral culture, or PCR
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 ClinicalTrials.gov identifier (NCT number): NCT02560909
|Principal Investigator:||Deepali Kumar, MD||University Health Network, Toronto|