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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
25
10\^3 PFU dose
placebo for rDEN2/4delta30(ME) vaccine
Center for Immunization Research
Baltimore, Maryland, United States
Determine the frequency of vaccine related AEs for each dose, graded by severity.
Time frame: Throughout study
Compare the immunogenicity of the two 2-dose regimens of the rDEN2/4Δ30(ME) candidate vaccine as assessed by neutralizing antibody titers to DEN2
Time frame: At 4 and 6 weeks after each vaccination
Assess the frequency, quantity, and duration of viremia after each dose of vaccine.
Time frame: Throughout study
Determine the number of vaccinees infected with rDEN2/4Δ30(ME)
Time frame: Throughout study
Comparison of infectivity rates, safety, and immunogenicity between dose 1 and dose 2 withhin cohort and between cohorts
Time frame: Throughout study
Evaluation of the phenotype and activation of peripheral blood mononuclear cells at primary infection and upon reinfection with the DEN2/4Δ30(ME) vaccine.
Time frame: Throughout study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.