Dengue Clinical Trial
Official title:
Evaluation of the Efficacy of the Live Attenuated Tetravalent Dengue Vaccine Against DENV-2 and DENV-3 Challenge
The purpose of this study is to evaluate the ability of a single dose of a live attenuated recombinant tetravalent dengue vaccine (TetraVax-DV-TV003, referred to as TV003) to protect against infection with a controlled human infection strain of either DENV-2 (rDEN2Δ30-7169) or DENV-3 (rDEN3Δ30) in adults 18 to 50 years of age with no history of previous flavivirus infection.
This study will evaluate the ability of a single dose of a live attenuated recombinant
tetravalent dengue vaccine (TetraVax-DV-TV003, referred to as TV003) to protect against
infection with a controlled human infection strain of either DENV-2 (rDEN2Δ30-7169) or DENV-3
(rDEN3Δ30) in adults 18 to 50 years of age with no history of previous flavivirus infection.
Participants will be randomly assigned to receive either TV003 or placebo at study entry (Day
0) and either rDEN2Δ30-7169 or rDEN3Δ30 on Day 28.
Study visits will occur on Days 0, 4, 6, 8, 10, 12, 14, 16, 21, 28, 32, 34, 36, 38, 40, 42,
44, 49, 56, 84, 118, and 208. Visits may include a physical examination and blood collection.
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