Safety and Immunogenicity of the Dengue Virus Vaccine TV005 (TetraVax-DV TV005) in Healthy Adults, Adolescents, and Children in Dhaka, Bangladesh
|ClinicalTrials.gov Identifier: NCT02678455|
Recruitment Status : Completed
First Posted : February 9, 2016
Last Update Posted : August 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Dengue||Biological: TV005 vaccine Biological: Placebo||Phase 2|
Dengue viruses (DENV) are the leading arboviral infection globally, with over 2 billion people at risk of infection worldwide. The first dengue fever outbreak in Bangladesh occurred in 2000, and since then, dengue fever has had a continued presence throughout Bangladesh. This study will evaluate the safety and immunogenicity of the recombinant live attenuated tetravalent dengue virus vaccine admixture TV005 (TetraVax-DV T005) in healthy adults, adolescents, and children in Dhaka, Bangladesh.
The study will enroll four cohorts of participants: adults, adolescents, children, and young children. Study researchers will evaluate study data for each cohort before enrolling the subsequent cohort.
Participants will be randomly assigned to receive either TV005 vaccine or placebo at study entry (Day 0). Additional study visits will occur on Days 7, 14, 28, 56, 180, 360, 720, and 1080. Study visits will include blood collection, physical examinations, and clinical assessments. Participants will record and monitor their temperature and symptoms until Day 14. Study staff will contact participants daily until Day 14; after Day 14, study staff will contact participants weekly (and after Day 180, monthly) throughout the study for follow-up health monitoring.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||192 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Immunogenicity of the Recombinant Live Attenuated Tetravalent Dengue Virus Vaccine Admixture TV005 (TetraVax-DV TV005) in Healthy Adults, Adolescents, and Children in Dhaka, Bangladesh|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||August 10, 2017|
|Actual Study Completion Date :||February 5, 2020|
Experimental: TV005 vaccine
Participants will receive one dose of TV005 vaccine at study entry (Day 0).
Biological: TV005 vaccine
Delivered by subcutaneous injection; contains 10^3 PFU of rDEN1Δ30, 10^4 PFU of rDEN2/4Δ30(ME), 10^3 PFU of rDEN3Δ30/31, and 10^3 PFU of rDEN4Δ30.
Other Name: TetraVax-DV T005
Placebo Comparator: Placebo
Participants will receive one dose of placebo at study entry (Day 0).
Delivered by subcutaneous injection
- Proportion of study participants with solicited or unsolicited adverse events [ Time Frame: Measured through Day 28 ]
- Proportion of study participants who are seropositive or seroconvert following vaccination [ Time Frame: Measured through Day 180 ]
- Proportion of study participants with vaccine virus recovered following vaccination [ Time Frame: Measured through Day 14 ]
- Proportion of study participants with recoverable vaccine virus or wild-type virus after vaccination [ Time Frame: Measured through Day 180 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678455
|International Centre for Diarrhoeal Disease Research, Bangladesh|
|Mirpur, Dhaka, Bangladesh|
|Principal Investigator:||Rashidul Haque, MD||Centre for Vaccine Sciences, International Centre for Diarrhoeal Disease Research, Bangladesh|
|Study Chair:||Beth D. Kirkpatrick, MD||Vaccine Testing Center, University of Vermont College of Medicine|