Impact of SQ vs IM Administration of DENVax on Safety and Immunogenicity

This study has been completed.
Sponsor:
Collaborator:
Walter Reed Army Institute of Research (WRAIR)
Information provided by (Responsible Party):
Inviragen Inc.
ClinicalTrials.gov Identifier:
NCT01728792
First received: October 16, 2012
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

This study will assess the Safety and Immunogenicity of DENVax vaccination via SC or IM administration with needle/syringe or needle-less injector


Condition Intervention Phase
Healthy
Biological: DENVax
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Impact of Subcutaneous Versus Intramuscular Administration of Inviragens Live Attenuated Dengue Vaccine on Safety and Immunogenicity

Resource links provided by NLM:


Further study details as provided by Inviragen Inc.:

Primary Outcome Measures:
  • Adverse events including injection site reactions. [ Time Frame: Each study visit from baseline to day 120. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Viremia and neutralizing antibodies will measured. [ Time Frame: Days 30 and 120 ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: January 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
SQ DENVax using needle/syringe
Biological: DENVax
DENVax is a live attenuated Dengue vaccine
Experimental: Group 2
IM DENVax using needle/syringe
Biological: DENVax
DENVax is a live attenuated Dengue vaccine
Experimental: Group 3
IM DENVax using needle/syringe
Biological: DENVax
DENVax is a live attenuated Dengue vaccine
Experimental: Group 4
SQ DENVax using needless injector
Biological: DENVax
DENVax is a live attenuated Dengue vaccine
Experimental: Group 5
IM DENVax using needless injector
Biological: DENVax
DENVax is a live attenuated Dengue vaccine

  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

Exclusion Criteria:

  • 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
  • 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.
  • 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: NCT01728792

Locations
United States, New York
Upstate Medical University
Syracuse, New York, United States
Sponsors and Collaborators
Inviragen Inc.
Walter Reed Army Institute of Research (WRAIR)
Investigators
Principal Investigator: Mark Polhemus, MD Upstate Medical University
  More Information

No publications provided

Responsible Party: Inviragen Inc.
ClinicalTrials.gov Identifier: NCT01728792     History of Changes
Other Study ID Numbers: INV-DEN-105
Study First Received: October 16, 2012
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Inviragen Inc.:
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ClinicalTrials.gov processed this record on October 23, 2014