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About
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.
Full description
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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Inclusion criteria
Exclusion criteria
Other Treatments and Ongoing Exclusion Criteria:
The following criteria will be reviewed on days 28 and 56 post-vaccination. If any become applicable during the study, then the subject will not be included in further immunogenicity evaluations, as of the exclusionary visit. The subject will, however, be encouraged to remain in the study for safety evaluations for the duration of the study.
Ongoing Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
14 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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