Dengue Fever Clinical Trial
Official title:
Phase 1 Study of the Safety and Immunogenicity of rDEN2/4delta30(ME), a Live Attenuated Virus Vaccine Candidate for the Prevention of Dengue Serotype 2
Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and subtropical regions of the world. The purpose of this study is to test the safety of and immune response to a new dengue virus vaccine in healthy adults.
Dengue viruses cause dengue fever, as well as the more severe dengue hemorrhagic fever/shock
syndrome. More than 2 billion people living in tropical and subtropical regions of the world
are at risk of dengue virus infection, which is the leading cause of hospitalization and
death in children in several tropical Asian countries. This study will evaluate the safety
and immunogenicity of a live attenuated dengue virus vaccine called rDEN2/4delta30(ME),
which is derived from the DEN2 and DEN4 serotypes.
This study will last 180 days. Participants in Cohort 1 will be randomly assigned to receive
rDEN2/4delta30(ME) or placebo at study entry. Cohort 2 will begin only after safety review
of all participants in Cohort 1. Participants in Cohort 2 will receive a higher dose of
rDEN2/4delta30(ME) or placebo.
After vaccination, participants will be observed for at least 30 minutes for immediate
adverse reactions. Participants will also be asked to monitor their temperature every day
for 16 days. Study visits will occur every other day after vaccination until Day 16,
followed by 4 additional visits at selected days through Day 180. Blood collection and a
targeted physical exam will occur at each study visit. Some participants will be asked to
undergo a skin biopsy or additional blood collection at selected visits.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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