Clinical trial NCT01644149: Clinical Trial Assessing the Immunologic Response to a Influenza Vaccine Delivered Using an Jet Injection Device or a Needle Syringe
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza Prophylaxis
Keywords: Jet Injector
Stratis®
PharmaJet
Jet Injection
Lead sponsor: PharmaJet, Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-18
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT)
timeFrame: 28 days
measure: The Percentage of Participants Achieving Seroconversion
timeFrame: 28 days
Secondary outcomes:
measure: Percentage of Subjects With Solicited Local or Systemic Adverse Events
timeFrame: 4 days
Other outcomes:
Locations:
city: Denver
country: United States
facility: Bel-Rea Institute
state: Colorado
Study officials:
affiliation: Bel-Rea Institute
name: Daniel Perlman, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: