Dengue Clinical Trial
Official title:
Evaluation of the Clinical and Immune Response Generated by Heterologous Attenuated Dengue Virus Infection
Dengue viruses infect millions of people throughout the tropics and subtropics each year. The development of a dengue vaccine is an important health priority. This study will evaluate the immunologic and clinical response to two dengue vaccines, given 9 months apart, in healthy adults with no history of previous flavivirus infection.
Dengue is a mosquito-borne flavivirus. There are 4 types of dengue virus (DENV-1, DENV-2,
DENV-3, and DENV-4), each of which can cause mild illness to life-threatening disease. The
purpose of this study is to evaluate the immunologic and clinical response to two dengue
vaccines (rDEN1Δ30 and rDEN2Δ30-7169), given 9 months apart, in healthy adults with no
history of previous flavivirus infection.
Participants will be randomly assigned to receive the rDEN1Δ30 vaccine or a placebo vaccine
at Day 0. Additional study visits will occur at Days 4, 6, 8, 10, 12, 14, 16, 21, 28, 56, 90,
180, and 240. At Day 270, all participants will receive the rDEN2Δ30-7169 vaccine. An
inpatient (overnight) stay will occur on Days 274 through 284, with participants being
discharged on Day 284, if they meet the study criteria. Additional visits will occur at Days
286, 291, 298, 326, 360, and 450. Study visits will include blood collection and a physical
examination. Participants will monitor and record their temperature 3 times a day for several
days after each vaccination.
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