Jet Injection for Influenza (JIFI)

Jet Injection for Influenza: A Randomized Controlled Clinical Trial to Demonstrate Non Inferiority of Jet Injection vs. Needle and Syringe for Administration of Trivalent Inactivated Influenza Vaccine

The purpose of this study is to determine if the administration of a seasonal flu vaccine using a PharmaJet's needle-free injection device (STRATIS) is equivalent to needle and syringe administration, as measured by laboratory tests of immune response.

Study Overview

• Status: Completed
• Conditions: Influenza, Human
• Intervention / Treatment: Biological: AFLURIA vaccine (2012-2013 formulation); Device: Needle-Syringe; Device: Stratis needle-free injection device

• Study Type: Interventional
• Enrollment (Actual): 1250
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Fort Collins, Colorado, United States, 80524
      • Poudre Valley Hospital
    • Fort Collins, Colorado, United States, 80528
      • University of Colorado Health Harmony Campus
    • Loveland, Colorado, United States, 80538
      • Medical Center of the Rockies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults aged ≥18 and ≤64 years of age at the time of enrollment
• Willing and able to give informed consent after reading the consent form and adequate opportunity to discuss the study with the investigator or qualified designee
• Willing and able to adhere to all protocol required study procedures and to attend scheduled visits.
• Able to receive the TIV influenza vaccine, based on University of Colorado Health (UCH) employee health flu screening guidelines.
• Stable health status with no exclusionary medical or neuropsychiatric conditions as determined during the screening evaluation and based on the clinical judgment of the investigator or qualified designee.
• Access to a consistent means of telephone contact

Exclusion Criteria:

• Presence of any febrile illness (oral temperature >38°C) on the day of immunization. Such subjects will be reevaluated for enrollment after resolution of illness.
• Presence of significant acute or chronic uncontrolled medical or neuropsychiatric illness and /or presence of any significant condition that may prohibit inclusion as determined by the investigator or his qualified designee. Uncontrolled is defined as: requiring institution of a new treatment within 1 month prior to study enrollment or change in medication dosage in the month prior to study enrollment.
• Any immunosuppressive condition including: history of HIV infection, cancer or cancer treatment within 3 years of study enrollment, systemic glucocorticoids (in a dose ≥10 mg prednisone daily or equivalent for more than 7 consecutive days or for 10 or more days in total) within 1 month of study enrollment, or any other cytotoxic or immunosuppressive drug within 3 months of study enrollment. Any significant disorder of coagulation that would increase the risk of intramuscular injections or treatment with Coumadin derivatives or heparin.
• Known or suspected to be allergic to eggs, chicken protein, gentamicin or influenza vaccine.
• History of severe or previous serious adverse reaction after an influenza vaccination.
• Receipt of any immunoglobulin and/or blood products within 3 months of immunization or planned administration of any of these products during the study period.
• Prior history of any demyelinating disease including Guillain-Barre syndrome.
• Presence of an active neurological disorder.
• History of significant alcohol or drug abuse within one year prior to study enrollment.
• Influenza vaccination or laboratory confirmed influenza infection within the previous six months before study vaccination or planned influenza vaccination during the study period.
• Planned administration of any non-influenza vaccines 30 days prior to the study or during the study period.
• Pregnant or plans to become pregnant during the study period.
• Currently enrolled in another vaccine or drug study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STRATIS Needle-Free; Patients assigned to this arm will receive AFLURIA vaccine administered using the Stratis needle-free injection device.	Biological: AFLURIA vaccine (2012-2013 formulation); Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.; Other Names: trivalent inactivated influenza vaccine (TIV); influenza virus vaccine; Device: Needle-Syringe; Device: Stratis needle-free injection device
Active Comparator: Needle-Syringe; Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.	Biological: AFLURIA vaccine (2012-2013 formulation); Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.; Other Names: trivalent inactivated influenza vaccine (TIV); influenza virus vaccine; Device: Needle-Syringe; Device: Stratis needle-free injection device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti Influenza Type A/H1N1 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)	The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for A/H1N1 antigen will not exceed 1.5 fold.	28 days
Anti Influenza Type A/H2N3 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)	The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for each antigen to not exceed 1.5 fold.	28 days
Anti Influenza Type B Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)	The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for each antigen to not exceed 1.5 fold.	28 days
Anti Influenza Type A/H1N1 Seroconversion	Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40.	28 days
Anti Influenza Type A/H3N2 Seroconversion	Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40.	28 days
Anti Influenza Type B Seroconversion	Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Complaints Within 30 Minutes Following Vaccination		Within 30 minutes post-vaccination
Number of Subjects With Vaccine Reactogenicity Events	Vaccine reactogenicity will be collected on a patient-completed diary card during checkout from Day 0 and on the next six evenings post-vaccination. The following adverse events will be solicited on the diary card: pain at injection site, tenderness at injection site, redness where the injection is given; induration/swelling (lump) where the injection is given; bruising where the injection is given; itching where the injection is given; headache; tiredness/fatigue (asthenia, lethargy, malaise); general muscle ache (myalgia); chills; nausea; vomiting. Subjects will also record their oral temperature on the diary card each evening.	Day 0, 1, 2, 3, 4, 5, and 6
Number of Subjects With Spontaneously Reported Adverse Events	Subjects will be asked to report any other symptoms experienced in addition to the solicited "immediate" and "vaccine reactogenicity" events. Any other events reported will be tabulated as spontaneously reported adverse events.	28 days
Percentage of Subjects Who Received a PJ Stratis Injection Would Choose to Receive This Type of Injection Again		28 Days

Collaborators and Investigators

• Sponsor: PharmaJet, Inc.
• Investigators: Principal Investigator: David K Cobb, MD, MPH, Rocky Mountain Infectious Disease Consultants; Study Director: Linda McAllister, MD, PhD, PharmaJet, Inc.

Publications and helpful links

General Publications

• McAllister L, Anderson J, Werth K, Cho I, Copeland K, Le Cam Bouveret N, Plant D, Mendelman PM, Cobb DK. Needle-free jet injection for administration of influenza vaccine: a randomised non-inferiority trial. Lancet. 2014 Aug 23;384(9944):674-81. doi: 10.1016/S0140-6736(14)60524-9. Epub 2014 May 31.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: September 17, 2012
• First Submitted That Met QC Criteria: September 17, 2012
• First Posted (Estimate): September 20, 2012

Study Record Updates

• Last Update Posted (Actual): November 1, 2017
• Last Update Submitted That Met QC Criteria: September 29, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Influenza Vaccines; Injections, Jet
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: PJ-501-12-2