Clinical Trial: Safety and Immunogenicity of the Dengue Virus Vaccine TV005 (TetraVax-DV TV005) in Healthy Adults, Adolescents, and Children in Dhaka, Bangladesh

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief Summary: The purpose of this study is to 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.

Detailed Summary:

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.


Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Current Primary Outcome:

  • 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 ]


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 5, 2016
Date Started: March 2016
Date Completion: February 2020
Last Updated: March 24, 2017
Last Verified: March 2017