Clinical Trial Assessing the Immunologic Response to a Influenza Vaccine Delivered Using an Jet Injection Device or a Needle Syringe

A Randomized Controlled Clinical Trial Assessing the Immunologic Response to an FDA-approved Influenza Vaccine Delivered Using an FDA-Cleared Jet Injection Vaccine Delivery Device or a Needle and Syringe

The primary objective of this study was to evaluate if administration of a seasonal flu vaccine using a jet injector device is comparable to traditional needle and syringe delivery for eliciting an immune response. A secondary objective was to compare the safety of the two delivery methods.

Study Overview

• Status: Completed
• Conditions: Influenza Prophylaxis
• Intervention / Treatment: Device: Stratis Jet Injector; Biological: 2011-2012 Fluzone trivalent inactivated influenza vaccine; Device: Needle and Syringe

Detailed Description

Needle-free jet injection devices create a fine stream of pressurized liquid that is able to deliver vaccines and other pharmaceutical products beneath the skin. Design aspects such as quality, pressure, orifice size, angle of injection relative to skin and injection stream coherence control the depth to which the product is delivered. This technology provides a safer delivery option for patients and healthcare staff by removing the need for needles for the administration of vaccines.

In addition to improved safety, additional benefits of using jet injectors include more consistent and reliable dose volume delivery, reduced vaccine waste, diminished need to transport large quantities of sharps, reduced risk of needle sticks, syringe reuse, and costs associated with sharps waste. Jet injectors offer a needle-free procedure to those individuals who are adverse to needles.

This study compared the efficacy of a disposable syringe jet injection device (Stratis) with traditional needle and syringe (NS) administration for the delivery of a trivalent inactivated influenza vaccine. Efficacy was evaluated by comparing measures of hemagglutination inhibition (HI); specifically GMTs, seroconversion and seroprotection. Safety of the two administration devices was evaluated by comparison of incidence of solicited local and systemic adverse events.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80247
      • Bel-Rea Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Female and male subjects ages 18 to 59 years
• Healthy volunteers
• Able to provide informed consent and understand study procedures per ICH/GCP guidelines
• Plans to remain in study area for length of the trial; able to adhere to study visit and follow-up schedule
• Able to complete study diary

Exclusion Criteria:

• Unwilling or unable to undergo the two blood draws per protocol
• Have received influenza vaccination in the last twelve months
• Have received any vaccination in the last month
• Currently taking antibiotics, steroids, phenytoin, chemotherapy, or other immunosuppressive drugs
• Received recent blood, blood products, or parenteral preparations of immunoglobulin (within 3 months)
• Suffers from allergic reactions to egg, gelatin, or neomycin or has a history of anaphylactic shock, asthma, urticaria, or other allergic reactions to vaccinations.
• Had any serious adverse event associated with a prior vaccination
• Has immunodeficiency or autoimmune disease (including HIV)
• History of chronic alcohol abuse
• Participating in another study concurrently
• Pregnant or breastfeeding during the 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 Jet Injector; Single intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine using the Stratis Jet Injector	Device: Stratis Jet Injector; Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine; Other Names: Jet Injector; Disposable Syringe Jet Injector; DSJI; Biological: 2011-2012 Fluzone trivalent inactivated influenza vaccine
Active Comparator: Needle and Syringe; Single intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine using Needle and Syringe	Biological: 2011-2012 Fluzone trivalent inactivated influenza vaccine; Device: Needle and Syringe; Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT)	The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio (GMT with Needle-Free / GMT with Needle and Syringe) antigen will not exceed 1.5 fold.	28 days
The Percentage of Participants Achieving 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
Percentage of Subjects With Solicited Local or Systemic Adverse Events	Vaccine reactogenicity will be collected on a patient-completed diary card daily for seven days post-vaccination. The following adverse events will be solicited on the diary card: injection site tenderness, injection site pain, injection site redness, injection site swelling, injection site itching, injection site bruising, fatigue, muscle aches, headache, decreased appetite, fever, pruritus.	4 days

Collaborators and Investigators

• Sponsor: PharmaJet, Inc.
• Investigators: Principal Investigator: Daniel Perlman, MD, MBA, Bel-Rea Institute

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: July 16, 2012
• First Submitted That Met QC Criteria: July 16, 2012
• First Posted (Estimate): July 18, 2012

Study Record Updates

• Last Update Posted (Actual): June 20, 2019
• Last Update Submitted That Met QC Criteria: June 18, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Jet Injector; Stratis®; PharmaJet; Jet Injection
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: PJ-500-07