Dengue Clinical Trial
Official title:
A Phase 1 Evaluation of the Safety and Protective Efficacy of a Single Dose of the Live Attenuated Tetravalent Dengue Vaccine TV005 to Protect Against Infection With Attenuated DENV-2, rDEN2∆30-7169
Dengue viruses are widespread in most tropical and subtropical regions of the world. This study will evaluate the safety and protective efficacy of a dengue vaccine (called TV005) against viremia and rash induced by a DENV-2 vaccine virus (called rDEN2∆30-7169) in healthy adults.
There are four types of dengue viruses (DENV-1, DENV-2, DENV-3, and DENV-4), each of which
can cause mild to life-threatening illness. This study will evaluate the protective efficacy
of TV005 (a dengue virus vaccine) administered at Day 0 against viremia and rash induced by
rDEN2∆30-7169 (a live attenuated candidate DENV-2 vaccine) administered at Day 180. The
safety and immunogenicity of the TV005 and rDEN2∆30-7169 vaccines will also be evaluated.
This study will enroll healthy adults with no history of previous infection with a dengue
virus or a flavivirus. Participants will be randomly assigned to receive a single injection
of TV005 or placebo at study entry (Day 0). All participants will receive a single injection
of rDEN2∆30-7169 on Day 180. For at least 30 minutes after each vaccination, participants
will remain in the study clinic to be monitored for any adverse effects of the vaccines.
Participants will record their temperature three times a day for 16 days after the first and
second vaccinations.
In addition to study visits at Day 0 and 180, participants will attend study visits at Day
4, 6, 8, 10, 12, 14, 16, 21, 28, 56, 90, 150, 184, 186, 188, 190, 192, 194, 196, 201, 208,
236, 270, and 360. At select study visits, participants will undergo a physical examination,
medical history review, blood collection, and a pregnancy test for female participants.
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