High Dose vs. Standard Influenza Vaccine in Adult SOT

NCT03139565 | Completed Phase 3

• 1 other identifier: UHNTID004
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

The study will test whether a high dose influenza vaccination results in improved immunogenicity in adult SOT recipients as compared to standard vaccine. This will be a single center prospective observer-blind randomized controlled trial conducted at the Toronto General Hospital Multi-Organ Transplant Unit, University Health Network, Toronto, Ontario, Canada.

Conditions

Influenza; Immunosuppression

Keywords

Influenza; Solid Organ Transplant; Infection; Vaccine; Immunogenicity

Outcome Measures

Primary Outcomes (1)

• Vaccine Immunogenicity (antibody titers)

  Comparing pre-vaccine and 4 weeks Post-Vaccine antibody titers. Positive vaccine response will be defined as: * Seroconversion rate of 4-fold or greater increase in HAI antibody titers to each of the three antigens in the vaccine, and * seroprotection rate determined by HAI tigers of 1\>=40 post immunization

  4 weeks

Secondary Outcomes (4)

• Vaccine Safety (local and systemic adverse events to vaccination).

  6 months

• Vaccine Safety (rates of rejection).

  6 months

• Vaccine Immunogenicity (CMI)

  4 weeks

• Vaccine Efficacy (influenza infection)

  6 months

Study Arms (2)

Fluzone High-dose Influenza Vaccine

EXPERIMENTAL

This treatment consists of 60 microgram of each influenza antigen provided as a single injection, which will be injected in the deltoid muscle of the non-dominant arm.

Biological: Fluzone High-dose Influenza Vaccine

Standard 2016-2017 Flu vaccine

ACTIVE COMPARATOR

This will be the Standard 2016-2017 influenza vaccine made available by public health. It will contain 15 microgram of each strain and will be delivered in the deltoid muscle of non-dominant arm.

Biological: Standard 2016-2017 Flu vaccine

Interventions

Fluzone High-dose Influenza Vaccine BIOLOGICAL

This treatment consists of 60 microgram of each influenza antigen provided as a single injection, which will be injected in the deltoid muscle of the non-dominant arm.

Fluzone High-dose Influenza Vaccine

Standard 2016-2017 Flu vaccine BIOLOGICAL

The intramuscular preparation of the vaccine used for the control group will be the Standard influenza vaccine made available by public health. The intramuscular dose (standard 0.5 mL) will contain 15 microgram antigen from each strain and delivered in the deltoid muscle by trained personnel.

Standard 2016-2017 Flu vaccine

Eligibility Criteria

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

You may qualify if:

• Organ transplant recipient on at least one immunosuppressive
• Age \>=18
• Outpatient status
• Greater than 3 months post transplant

You may not qualify if:

• Has already received influenza vaccination for 2016-2017 season
• Egg allergy or allergy to previous influenza vaccine
• Febrile illness in the past one week
• Active Cytomegalovirus viremia
• Use of Rituximab in the past 6 months
• Ongoing or recent (in past 30 days) therapy for acute rejection
• Chronic kidney insufficiency (creatinine clearance ≤30mL/min or dialysis-dependent
• Previous life-threatening reaction to influenza vaccine (i.e. Guillain Barre Syndrome)
• Receipt of intravenous immunoglobulin (IVIG) in the past 30 days or planning to receive IVIG in the next 4 weeks

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network, Toronto General Hospital, Multi-Organ Transplant

Toronto, Ontario, M5G2N2, Canada

Location

Related Publications (1)

• Natori Y, Shiotsuka M, Slomovic J, Hoschler K, Ferreira V, Ashton P, Rotstein C, Lilly L, Schiff J, Singer L, Humar A, Kumar D. A Double-Blind, Randomized Trial of High-Dose vs Standard-Dose Influenza Vaccine in Adult Solid-Organ Transplant Recipients. Clin Infect Dis. 2018 May 17;66(11):1698-1704. doi: 10.1093/cid/cix1082.

  PMID: 29253089 DERIVED

MeSH Terms

Conditions

Influenza, Human; Infections

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract 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 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, 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: April 6, 2017
• First Posted: May 4, 2017
• Study Start: October 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)