Dengue Fever Clinical Trial
Official title:
Impact of Subcutaneous Versus Intramuscular Administration of Inviragen's Live Attenuated Dengue Vaccine on Safety and Immunogenicity
This study assessed the safety and immunogenicity of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) previously referred to as DENVax of various dosing schedules via subcutaneous (SC) or intramuscular (IM) administration with needle/syringe or needle-free injector (PharmaJet Stratis™).
The vaccine tested in this study was TDV. TDV was tested to assess safety and immunogenicity
of various dosing schedules, routes of administration, and delivery methods in healthy
flavivirus-seronegative adults living in a dengue non-endemic country.
The study enrolled 80 participants. Participants were randomly assigned to one of the five
treatment groups:
- Group 1: TDV SC injection on Day 0 in each arm using needle/syringe
- Group 2: TDV IM injection on Day 0 in each arm using needle/syringe
- Group3: TDV IM injection on Days 0 and 90 using needle/syringe
- Group 4: TDV SC on Day 0 in each arm using the PharmaJet Stratis™ device
- Group 5: TDV IM on Day 0 in each arm using the PharmaJet Stratis™ device
This single-center trial was conducted in the United States. The overall time to participate
in this study was up to 5 months. Participants made multiple visits to the clinic including a
final visit at Day 120 for a safety follow-up assessment.
This work was supported by the US Army Medical Research and Materiel Command under Contract
No. W81XWH-12-C-0278.
The views, opinions and/or findings contained in this report are those of the author(s) and
should not be construed as an official Department of the Army position, policy or decision
unless so designated by other documentation.
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