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

This study is currently recruiting participants.

Verified March 2013 by Inviragen Inc.

Sponsor:

Collaborator:

National Institutes of Health (NIH)

Information provided by (Responsible Party):

Inviragen Inc.

ClinicalTrials.gov Identifier:

NCT01765426

First received: December 17, 2012

Last updated: March 26, 2013

Last verified: March 2013

History of Changes

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:

MedlinePlus related topics: Dengue

U.S. FDA Resources

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:	December 2013
Estimated Primary Completion Date:	November 2013 (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01765426

Contacts

Contact: Gilad Gordon, MD	970.692.5516
Contact: Carrie VanDuym	303.589.0759

Locations

United States, Texas
University of Texas Medical Branch	Recruiting
Galveston, Texas, United States, 77555
Contact: Carrie Harrington, RN clharrin@utmb.edu
Principal Investigator: Richard Rupp, MD

Sponsors and Collaborators

Inviragen Inc.

National Institutes of Health (NIH)

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:	March 26, 2013
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 23, 2013

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