Clinical Trial: Evaluation of the Safety and Immunogenicity of rDEN3Δ30, a Live Attenuated Monovalent Dengue Virus Vaccine
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 1 Evaluation of the Safety and Immunogenicity of rDEN3Δ30, a Live Attenuated Monovalent Dengue Virus Vaccine
Brief Summary: 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.
Detailed Summary:
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.
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Current Primary Outcome:
- Frequency of vaccine-related adverse events (AEs) [ Time Frame: Measured through Day 28 post-vaccination ]
- Level of anti-DENV-3 neutralizing antibody [ Time Frame: Measured through Day 180 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: National Institute of Allergy and Infectious Diseases (NIAID)
Dates:
Date Received: February 16, 2016
Date Started:
Date Completion:
Last Updated: November 29, 2016
Last Verified: November 2016
