Clinical trial NCT02560909: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Transplantation
Influenza Vaccines
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2015-09-25
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Rates of seroconversion
timeFrame: 4 weeks from vaccination
Secondary outcomes:
measure: Rates of seroprotection
timeFrame: 4 weeks from vaccination
measure: Rate of Local and systemic adverse events to vaccination
timeFrame: within 7 days of vaccination
measure: Number of participants with microbiologically-documented influenza infection
timeFrame: 6 months from vaccination
Other outcomes:
Locations:
Study officials:
affiliation: University Health Network, Toronto
name: Deepali Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References: