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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

December 17, 2012
December 16, 2013
March 2013
March 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01765426 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Phase 1b Study Investigating Safety & Immunogenicity of DENVax Given Intradermally by Needle or Needle Free PharmaJet Injector
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

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).

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Normal Healthy Adult
  • Biological: DENVax
    low dose given intradermally
  • Device: PharmaJet Injector
  • Experimental: ID DENVax using needle-less PharmaJet injector
    DENVax Vaccine- low dose
    Interventions:
    • Biological: DENVax
    • Device: PharmaJet Injector
  • Experimental: ID DENVax using neele-less PharmaJet injector
    DENVax Vaccine - low dose
    Interventions:
    • Biological: DENVax
    • Device: PharmaJet Injector
  • Experimental: ID DENVax using needle/syringe
    DENVax Vaccine - low dose
    Intervention: Biological: DENVax
  • Experimental: ID DENVax using needle-free PharmaJet injector
    DENVax Vaccine - low dose
    Interventions:
    • Biological: DENVax
    • Device: PharmaJet Injector
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
96
August 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01765426
11-0049
Yes
Inviragen Inc.
Inviragen Inc.
National Institutes of Health (NIH)
Study Director: Gilad Gordon, MD Inviragen Inc.
Inviragen Inc.
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP