Evaluating the Safety and Immunogenicity of a Tetravalent Dengue Vaccine (TetraVax-DV) TV005 in Flavivirus-Naive Adults 50 to 70 Years of Age
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|ClinicalTrials.gov Identifier: NCT02879266|
Recruitment Status : Completed
First Posted : August 25, 2016
Last Update Posted : April 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Dengue||Biological: TetraVax-DV TV005 Biological: Placebo||Phase 1|
Dengue viruses (DENV) are widespread in most tropical and subtropical regions of the world. There are four serotypes of dengue virus (DENV-1, DENV-2, DENV-3, and DENV-4); each can cause dengue infection. Infection with dengue viruses can range from mild illness to life-threatening disease. TetraVax-DV TV005 (also referred to as TV005) is a live attenuated recombinant tetravalent dengue virus vaccine developed to protect against all four dengue virus serotypes. The purpose of this study is to evaluate the safety and immunogenicity of TV005 in adults 50 to 70 years of age with no history of previous flavivirus infection.
Participants will be randomly assigned to receive a subcutaneous injection of either TV005 or placebo at study entry (Day 0). After receiving the injection, participants will record their temperature 3 times a day through Day 16. Additional study visits will occur on Days 4, 6, 8, 10, 12, 14, 16, 21, 28, 56, 90, and 180. Visits will include a physical examination and blood collection.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase I Evaluation of the Safety and Immunogenicity of an Investigational Tetravalent Dengue Vaccine (TetraVax-DV) TV005 in Flavivirus-Naïve Adults 50 - 70 Years of Age|
|Actual Study Start Date :||February 1, 2016|
|Actual Primary Completion Date :||September 7, 2017|
Experimental: TetraVax-DV TV005
Participants will receive a subcutaneous injection of TetraVax-DV TV005 at study entry (Day 0).
Biological: TetraVax-DV TV005
Contains 10^3 plaque-forming units (PFUs) of rDEN1Δ30, 10^4 PFUs of rDEN2/4Δ30(ME), 10^3 PFUs of rDEN3Δ30/31-7164, and 10^3 PFUs of rDEN4Δ30; administered by subcutaneous injection in the deltoid region of the upper arm
Other Name: TV005
Placebo Comparator: Placebo
Participants will receive a subcutaneous injection of placebo at study entry (Day 0).
Administered by subcutaneous injection in the deltoid region of the upper arm
- Frequency of TV005-related adverse events (AEs) [ Time Frame: Measured through Day 180 ]AEs classified by both severity and seriousness, through active and passive surveillance
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): NCT02879266
|United States, Maryland|
|Center for Immunization Research, Johns Hopkins School of Public Health|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Anna Durbin, MD||Center for Immunization Research (CIR), Johns Hopkins School of Public Health|