Dengue Clinical Trial
Official title:
A Phase 1 Evaluation of the Safety and Protective Efficacy of a Single Dose of a Trivalent Live Attenuated Dengue Vaccine to Protect Against Infection With DENV-2
Infection with dengue viruses is the leading cause of hospitalization and death in children in many tropical Asian countries, and the development of a dengue vaccine is a top health priority. This study will evaluate the ability of a single dose of a trivalent dengue vaccine to protect against infection with an attenuated candidate DENV-2 vaccine, administered 6 months after the trivalent dengue vaccine.
There are 4 types of dengue virus (DENV-1, DENV-2, DENV-3, and DENV-4), each capable of
causing dengue illness ranging from a mild illness to life-threatening disease. This study
will evaluate a trivalent live attenuated dengue admixture vaccine that contains 3 different
monovalent dengue vaccine candidates, representing 3 of the 4 dengue serotypes (DENV-1,
DENV-3, and DENV-4). Study researchers will evaluate the safety and protective efficacy of a
single dose of the trivalent dengue vaccine against viremia and rash induced by infection
with an attenuated DENV-2 virus (rDEN2Δ30-7169), administered 6 months after the trivalent
dengue vaccine.
This study will enroll healthy adults with no history of previous flavivirus infection. At
Day 0 (study entry), participants will be randomly assigned to receive either the trivalent
dengue vaccine admixture or placebo. On Day 180, all participants will receive the
rDEN2Δ30-7169 vaccine. Study visits will occur on Days 4, 6, 8, 10, 12, 14, 16, 21, 28, 56,
90, 150, 180, 184, 186, 188, 190, 192, 194, 196, 201, 208, 236, 270, and 360. Visits will
include physical examinations and blood collection. All participants will record their
temperature 3 times a day for 16 days after each vaccination.
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