Dengue Fever Clinical Trial
Official title:
Safety and Immunogenicity of a 2-Dose Regimen of rDEN2/4Δ30 Dengue Vaccine With Boosting at 4 Versus 6 Months
Dengue fever, caused by dengue viruses, is a major health problem in the 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, which cause dengue fever and dengue shock syndrome, are a major cause of
morbidity and mortality in several of the world's tropical and subtropical regions. The
rDEN2/4delta30(ME) vaccine is a live attenuated dengue virus vaccine that may be protective
against dengue virus serotype 2 (DEN2). The purpose of this study is to evaluate the safety
and immunogenicity of the rDEN2/4delta30(ME) vaccine in healthy adults.
This study will last approximately 5 to 7 months with 25 study visits. Participants will be
randomly assigned into one of two cohorts. Participants in Cohort 1 will receive an
injection of rDEN2/4delta30(ME) or placebo vaccine at Days 0 and 180. Participants in Cohort
2 will receive an injection of rDEN2/4delta30(ME) or placebo vaccine at Days 0 and 120.
Participants will be asked to record their temperature in a diary for 16 days after each
vaccination. At each study visit a physical examination, symptom history, and blood and
urine collection will occur.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
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