Comparison of Routine IM Influenza Immunization and Administration by Jet-injector (Med-Jet H4™) in Healthy Young Adults (Med-Jet H4™)

Comparison of Routine IM Influenza Immunization and Administration by Jet-injector (Med-Jet MIT H4™ & Disposable Cartridge) in Healthy Young Adults

80 subjects (healthy adults) will be randomized to receive the seasonal flu vaccine either by needle & syringe or by the MIT needle-free injector (Med-Jet MIT H4™ & Disposable Cartridge). The study will be conducted after the normal flu season has passed (ie: March-April). Half of those randomized to standard vaccination (n=20) will receive vaccine drawn from a multi-dose vial while the other half (n=20) will receive vaccine drawn from a single use vial. The same vaccine as the multi-dose vial will be delivered to the other half of the subjects (n=40) using the MIT injector. How long it takes to prepare and deliver the vaccines will be assessed (a time-motion study). Subject acceptance before and after injection will be assessed as well as local and systemic side effects. Standard serologic measures of immune response to flu vaccination (ie: antibodies) will determine whether the Med-Jet H4 injector induces the same kind of immune response as needle & syringe delivery.

Study Overview

• Status: Completed
• Conditions: Needle Phobia
• Intervention / Treatment: Biological: Fluviral influenza vaccine

Detailed Description

Eighty healthy adults (18-49 years of age) will be randomized 1:1 to receive:

• A single dose of trivalent inactivated influenza vaccine (TIV: Fluviral™: 0.5mL IM)

  • Half will receive the vaccine using a pre-filled syringe
  • Half will receive the vaccine using a multi-dose vial
• Or,the same vaccine delivered IM using the Medical International Technologies Inc. (MIT) compressed air vaccine delivery system (Med-Jet MIT H4 & Disposable Cartridge).

Primary study outcomes will be i) safety (local and systemic reactions) followed for 21 days and ii) immunogenicity at 21 days using the standard serologic assays (eg: hemaggultination inhibition (HI) and microneutralization (MN)).

Secondary outcomes will be time-motion analyses of vaccine preparation and administration to assess possible time-saving associated with Med-Jet H4 delivery.

Although full blinding of the study is not possible give the very different vaccine delivery methods, all safety assessments and immunological parameters will be collected by nurses/technicians blinded to group assignment (ie: observer blind).

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Pierrefonds, Quebec, Canada, H9H 4Y6
      • McGill University Health Centre Vaccine Study Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male and female adults
• 18 to 49 years of age
• body mass index (BMI) of ≥ 18 kg/m2 and ≤ 32 kg/m2
• Must be accessible by phone on a consistent basis and be available for the D21 blood draw

Exclusion Criteria:

• Any influenza vaccine during the 2016-2017 season
• significant acute or chronic, uncontrolled medical or neuropsychiatric illness
• confirmed or suspected immunosuppressive condition or immunodeficiency
• history of autoimmune disease, cancer, or treatment for cancer within 3 years of study vaccine administration
• Receipt of any investigational or non-registered product within 30 days prior to study enrolment
• receipt of systemic glucocorticoids at a dose exceeding 10 mg of prednisone per day, or equivalent, for more than 7 consecutive days or for 10 or more days in total within 1 month of vaccine administration
• any other cytotoxic or immunosuppressant drug or any globulin preparation within 3 months of vaccination
• blood transfusion within 90 days of study vaccination
• Although there is no known danger from influenza vaccination during pregnancy, pregnant women will be excluded since the efficacy of the Med-Jet delivery system is not yet known
• known drug or alcohol abuse will also be excluded.

Temporary Contraindications Following the resolution, in the opinion of the Investigator, of the following temporary conditions that constitute contraindications to administration of study vaccine, subjects may be enrolled in the study:

• Temperature ≥ 38.0 ºC within 24 hours prior to randomization.
• Acute cold symptoms such as upper respiratory tract infection symptoms, with or without fever, which typically resolve in 48 to 72 hours prior to randomization.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Jet injector; 40 participants will receive Fluviral influenza vaccine using the Med-Jet H4	Biological: Fluviral influenza vaccine; Influenza vaccine (Fluviral) given via Med-Jet H4 or IM injection
Active Comparator: IM injection (pre-filled syringe); 20 participants will receive Fluviral influenza vaccine using pre-filled syringes for time-motion comparison to Med-Jet H4	Biological: Fluviral influenza vaccine; Influenza vaccine (Fluviral) given via Med-Jet H4 or IM injection
Active Comparator: IM injection (multi-dose vial); 20 participants will receive Fluviral influenza vaccine using a multi-dose vial for time-motion comparison to Med-Jet H4	Biological: Fluviral influenza vaccine; Influenza vaccine (Fluviral) given via Med-Jet H4 or IM injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local and systemic effects will be measured after vaccination	Solicited and unsolicited local and systemic adverse events will be collected between day 0-3 by phone and day 4-21 by diary after influenza vaccine (TIV) delivered by jet-injector or by standard needle.	0 - 21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to administer vaccine by jet-injector or standard needle will be measured	Each component of the vaccination process using either the jet-injector or a standard needle will be measured (time-motion study) to determine which method is faster	Day 0 (day of immunization)
Immunogenicity of influenza vaccine given by needle or jet injector	Standard serologic assays will be performed on serum obtained on day 0 (day of injection) and day 21 to measure hemagglutination inhibition and microneutralization titres in subjects who received the vaccine by either standard needle or jet injector.	Day 0 (day of immunization) and day 21

Collaborators and Investigators

• Sponsor: brian.ward
• Collaborators: MedTeq; MEDICAL INTERNATIONAL TECHNOLOGIES (MIT CANADA) INC.
• Investigators: Principal Investigator: Brian J Ward, MD, Research Institute of the McGill University Helath Centre

Publications and helpful links

General Publications

• Shapiro JR, Hodgins B, Hendin HE, Patel A, Menassa K, Menassa C, Menassa M, Pereira JA, Ward BJ. Needle-free delivery of influenza vaccine using the Med-Jet(R) H4 is efficient and elicits the same humoral and cellular responses as standard IM injection: A randomized trial. Vaccine. 2019 Feb 28;37(10):1332-1339. doi: 10.1016/j.vaccine.2019.01.039. Epub 2019 Jan 29.

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2017
• Primary Completion (Actual): June 14, 2017
• Study Completion (Actual): November 6, 2017

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: May 9, 2017
• First Posted (Actual): May 12, 2017

Study Record Updates

• Last Update Posted (Actual): August 15, 2018
• Last Update Submitted That Met QC Criteria: August 14, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: influenza vaccine; immune response; jet injector
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: RI-MUHC: 2017-3307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No