Evaluation of the Safety and Immunogenicity of rDEN3Δ30, a Live Attenuated Monovalent Dengue Virus Vaccine
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||A Phase 1 Evaluation of the Safety and Immunogenicity of rDEN3Δ30, a Live Attenuated Monovalent Dengue Virus Vaccine|
- Frequency of vaccine-related adverse events (AEs) [ Time Frame: Measured through Day 28 post-vaccination ] [ Designated as safety issue: Yes ]
- Level of anti-DENV-3 neutralizing antibody [ Time Frame: Measured through Day 180 ] [ Designated as safety issue: No ]
|Study Completion Date:||July 2016|
|Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Experimental: rDEN3∆30 vaccine
Participants will receive the rDEN3∆30 vaccine at Day 0.
10^3 plaque-forming units (PFUs); administered by subcutaneous injection in the deltoid region of the upper arm
Placebo Comparator: Placebo
Participants will receive placebo at Day 0.
Administered by subcutaneous injection in the deltoid region of the upper arm
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02684383
|United States, Maryland|
|Center for Immunization Research (CIR), Johns Hopkins School of Public Health|
|Baltimore, Maryland, United States, 21205|
|United States, Vermont|
|University of Vermont Medical Center|
|Burlington, Vermont, United States, 05401|
|Principal Investigator:||Kristen Pierce, MD||University of Vermont|