Dengue Clinical Trial
Official title:
A Phase 1 Evaluation of the Safety and Immunogenicity of rDEN2Δ30-7169, a Live Attenuated Monovalent Dengue Virus Vaccine
Dengue viruses can cause dengue fever and other more serious illnesses. The purpose of this study is to evaluate the safety and immune response to a dengue virus vaccine.
Dengue viruses can cause dengue fever and the more severe disease, dengue hemorrhagic
fever/shock syndrome (DHF/DSS). Infection with dengue viruses is the leading cause of
hospitalization and death in children in at least 8 tropical Asian countries. There are 4
types of dengue virus (DENV-1, DENV-2, DENV-3, and DENV-4), each of which can cause dengue
illness ranging from a mild illness to life-threatening disease. This study will evaluate
the experimental rDEN2Δ30-7169 vaccine for the prevention of illness due to DENV-2. The
purpose of this study is to evaluate the safety and immunogenicity of this vaccine in
healthy adults with no history of previous flavivirus infection.
At study entry, participants will be randomly assigned to receive either the dengue virus
vaccine or placebo. They will remain in the clinic for 30 minutes after receiving the
injection for monitoring. Study visits will occur at Days 2, 4, 6, 8, 10, 12, 14, 16, 21,
28, 56, and 180. All study visits will include a blood collection, and most study visits
will include a physical examination. Female participants will have a pregnancy test at
select visits. Participants will record their temperature at least 3 times a day for the
first 16 days; study researchers will review these readings during the study visits.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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