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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PharmaJet, Inc.
ClinicalTrials.gov Identifier:
NCT01644149
First received: July 16, 2012
Last updated: March 14, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Influenza Prophylaxis
Device: Stratis Jet Injector
Device: Needle and Syringe
Biological: 2011-2012 Fluzone trivalent inactivated influenza vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by PharmaJet, Inc.:

Primary Outcome Measures:
  • Hemagglutination Inhibition Geometric Mean Titers [ Time Frame: One month ] [ Designated as safety issue: No ]
    GMTs were measured for each of the three influenza types (H1N1, H3N2, and influenza B) on a log scale comparing the jet injector device group and the needle and syringe group.


Secondary Outcome Measures:
  • HI seroconversion [ Time Frame: One month ] [ Designated as safety issue: No ]
    Seroconversion was defined as a 4-fold increase in antibody titers compared to pre-vaccination levels when the baseline titer was found to be greater than 10; or simply > 40 when the baseline titer was ≤ 10.

  • HI seroprotection [ Time Frame: One month ] [ Designated as safety issue: No ]
    Seroprotection was defined as a HI titer ≥ 40 that was met and maintained throughout the study.


Enrollment: 83
Study Start Date: January 2012
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Device: Needle and Syringe
Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine
Biological: 2011-2012 Fluzone trivalent inactivated influenza vaccine

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

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01644149

Locations
United States, Colorado
Bel-Rea Institute
Denver, Colorado, United States, 80247
Sponsors and Collaborators
PharmaJet, Inc.
Investigators
Principal Investigator: Daniel Perlman, MD, MBA Bel-Rea Institute
  More Information

No publications provided

Responsible Party: PharmaJet, Inc.
ClinicalTrials.gov Identifier: NCT01644149     History of Changes
Other Study ID Numbers: PJ-500-07
Study First Received: July 16, 2012
Last Updated: March 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by PharmaJet, Inc.:
Jet Injector
Stratis®
PharmaJet
Jet Injection

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 21, 2014