Evaluation of the Safety and Immunogenicity of rDEN3Δ30, a Live Attenuated Monovalent Dengue Virus Vaccine
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|ClinicalTrials.gov Identifier: NCT02684383|
Recruitment Status : Completed
First Posted : February 18, 2016
Last Update Posted : November 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Dengue||Biological: rDEN3∆30 Biological: Placebo||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 1 Evaluation of the Safety and Immunogenicity of rDEN3Δ30, a Live Attenuated Monovalent Dengue Virus Vaccine|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|