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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Influenza Prophylaxis

Intervention / Treatment
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* Device: Stratis Jet Injector
* Device: Needle and Syringe
* Biological: 2011-2012 Fluzone trivalent inactivated influenza vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stratis Jet Injector<br>Single intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine using the Stratis Jet Injector | Device: Stratis Jet Injector<br>* Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine<br>* Other names: DSJI;Biological: 2011-2012 Fluzone trivalent inactivated influenza vaccine<br> <br> |
| Active Comparator: Needle and Syringe<br>Single intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine using Needle and Syringe | Device: Needle and Syringe<br>* Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine<br>Biological: 2011-2012 Fluzone trivalent inactivated influenza vaccine<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Jet Injector, Stratis®, PharmaJet, Jet Injection