Healthy Volunteers Clinical Trial
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
The purpose of this study is to compare the safety, tolerability and immunogenicity of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] when administered intradermally in varied dosing schedules and via different methods of administration (conventional needle/syringe versus needle-free PharmaJet® injector).
This is an exploratory trial to assess the safety, tolerability and immunogenicity of
vaccination with a tetravalent dengue vaccine (TDV) 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
participants (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).
Participants will be evaluated for safety and dengue neutralizing antibody to all four
serotypes. All participants will also be evaluated for injection site reactions and have
blood drawn for viremia, neutralizing antibodies, cell mediated immunity and innate immunity.
Participants 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 (through Day 270).
This project has been funded in whole or in part with Federal funds from the National
Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of
Health and Human Services, under Contract No. HHSN272201000034C.
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