Phase 1b Study Investigating Safety & Immunogenicity of DENVax Given Intradermally by Needle or Needle Free PharmaJet Injector

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Inviragen Inc.
ClinicalTrials.gov Identifier:
NCT01765426
First received: December 17, 2012
Last updated: December 16, 2013
Last verified: June 2013
  Purpose

This is an exploratory trial to assess the safety, tolerability and immunogenicity of vaccination with a tetravalent dengue vaccine in healthy adults delivered intradermally using the conventional needle/syringe or a needle-free PharmaJet® injector. Two (2) intradermal injections of either vaccine or placebo will be administered to qualified subjects (one in each arm) on Day 0 of the study. A subsequent injection will also be given on Day 90 with either vaccine or placebo (in one arm only). Subjects will be evaluated for safety, measurement of viremia for all four dengue serotypes and dengue neutralizing antibody to all four serotypes. All subjects will be evaluated for injection site evaluations and have blood drawn for viremia, neutralizing antibodies, cell mediated immunity and innate immunity. Subjects will be required to participate for approximately 10 months from recruitment and collection of data for primary outcomes (through Day 120) including collection of additional samples for measurement of longer term antibody titers (Day 270).


Condition Intervention Phase
Normal Healthy Adult
Biological: DENVax
Device: PharmaJet Injector
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase 1b, Partial-Blind, Parallel Group, Randomized Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine (DENVax) Administered Intradermally Using Needle or a Needle-Free PharmaJet® Injector in Healthy Adults

Resource links provided by NLM:


Further study details as provided by Inviragen Inc.:

Primary Outcome Measures:
  • Adverse event frequency [ Time Frame: 120 Days ] [ Designated as safety issue: Yes ]
  • Neutralizing antibody titer comparison of the four dengue serotypes [ Time Frame: 270 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To measure neutralizing antibodies due to each of the four dengue vaccine components after each vaccination [ Time Frame: 270 Days ] [ Designated as safety issue: No ]
  • To evaluate the safety following ID administration of DENVax using the PharmaJet® needle-free injector [ Time Frame: 120 days ] [ Designated as safety issue: Yes ]
  • To measure viremia due to each of the four dengue vaccine components [ Time Frame: 104 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: March 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ID DENVax using needle-less PharmaJet injector
DENVax Vaccine- low dose
Biological: DENVax
low dose given intradermally
Device: PharmaJet Injector
Experimental: ID DENVax using neele-less PharmaJet injector
DENVax Vaccine - low dose
Biological: DENVax
low dose given intradermally
Device: PharmaJet Injector
Experimental: ID DENVax using needle/syringe
DENVax Vaccine - low dose
Biological: DENVax
low dose given intradermally
Experimental: ID DENVax using needle-free PharmaJet injector
DENVax Vaccine - low dose
Biological: DENVax
low dose given intradermally
Device: PharmaJet Injector

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • In good health as determined by medical history, physical examination and laboratory tests
  • Negative for HIV, Hepatitis B & C
  • Body Mass Index (BMI) ≤ 35 kg/m2

Exclusion Criteria:

  • Any Grade 2 or above abnormality in the screening laboratory tests
  • History of Dengue fever, Japanese encephalitis, West Nile or Yellow Fever disease
  • Seropositivity to dengue or West Nile virus
  • Extensive scarring or tattoo (> 50%) on arms, shoulders, neck face and head
  • History of significant dermatologic disease in the last 6 months
  • Receipt or planned receipt of any vaccine in the 4 weeks preceding or following the vaccinations
  • Any planned travel to dengue endemic areas including the Caribbean, Mexico, Central America, South America or Southeast Asia, during the study period and during the month prior to screening
  • Use of systemic corticosteroids therapy within the previous 6 months (at a dose of 0.5 mg/kg/day). Topical prednisone is not permitted if currently in use or used within the last month.
  • Use of any prescription or over the counter medication that has not been stable for 30 days
  • Planned donation of blood during the period of 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: NCT01765426

Locations
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555
United States, Washington
Group Health Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Inviragen Inc.
Investigators
Study Director: Gilad Gordon, MD Inviragen Inc.
  More Information

No publications provided

Responsible Party: Inviragen Inc.
ClinicalTrials.gov Identifier: NCT01765426     History of Changes
Other Study ID Numbers: 11-0049
Study First Received: December 17, 2012
Last Updated: December 16, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 18, 2014