Dengue Clinical Trial
Official title:
A Phase 1 Evaluation of the Safety and Immunogenicity of rDEN3Δ30, a Live Attenuated Monovalent Dengue Virus Vaccine
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 safety and immunogenicity of a live attenuated monovalent dengue virus vaccine (rDEN3Δ30) in healthy adults with no history of previous flavivirus infection.
The purpose of this study is to evaluate the safety and immunogenicity of a live attenuated
monovalent dengue virus vaccine (rDEN3Δ30) in healthy flavivirus-naive adults.
Participants will be randomly assigned to receive the rDEN3Δ30 vaccine or placebo at Day 0.
Study visits will occur on Days 2, 4, 6, 8, 10, 12, 14, 16, 21, 28, 56, 90, and 180. Visits
will include physical examinations and blood collection. All participants will record their
temperature 3 times a day from Day 0 through Day 16. Some participants may be admitted to
the clinic for an inpatient (overnight) stay during the first 16 days of the study.
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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