Adjuvanted Influenza Vaccine in Stem Cell Transplant

NCT02560909 | Completed Phase 4

• 1 other identifier: 15-9503
• Study Type: interventional
• Target: 73
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Transplantation; Influenza Vaccines

Outcome Measures

Primary Outcomes (1)

• Rates of seroconversion

  serological response with a four-fold or greater increase in HI antibody titers to an antigen

  4 weeks from vaccination

Secondary Outcomes (3)

• Rates of seroprotection

  4 weeks from vaccination

• Rate of Local and systemic adverse events to vaccination

  within 7 days of vaccination

• Number of participants with microbiologically-documented influenza infection

  6 months from vaccination

Study Arms (2)

Experimental

EXPERIMENTAL

The experimental group will receive one dose MF59 adjuvanted intramuscular vaccine.

Biological: FLUAD® influenza vaccine

Control

ACTIVE COMPARATOR

The control group will receive one dose of the standard 2015-2016 nonadjuvanted vaccine.

Biological: FLUVIRAL®

Interventions

FLUAD® influenza vaccine BIOLOGICAL

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.

Also known as: MF59 adjuvanted vaccine

Experimental

FLUVIRAL® BIOLOGICAL

Standard 2015-2016 nonadjuvanted vaccine

Also known as: Trivalent Influenza Vaccine

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Deepali Kumar, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Transplant Infectious Diseases

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: September 25, 2015
• Study Start: October 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: August 1, 2016
• Last Updated: April 10, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share