Clinical Trial: Safety and Immune Response to Two Doses of rDEN2/4delta30 Dengue Vaccine
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Safety and Immunogenicity of a 2-Dose Regimen of rDEN2/4Δ30 Dengue Vaccine With Boosting at 4 Versus 6 Months
Brief Summary: 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.
Detailed Summary:
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.
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Current Primary Outcome:
- 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: National Institute of Allergy and Infectious Diseases (NIAID)
Dates:
Date Received: June 11, 2009
Date Started: January 2009
Date Completion:
Last Updated: December 31, 2012
Last Verified: December 2012