NCT02879266

Evaluating the Safety and Immunogenicity of a Tetravalent Dengue Vaccine (TetraVax-DV) TV005 in Flavivirus-Naive Adults 50 to 70 Years of Age

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 50 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety and immunogenicity of a tetravalent dengue vaccine TetraVax-DV TV005 in adults 50 to 70 years of age with no history of previous flavivirus infection.

Detailed description

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.

Conditions

• Dengue

Interventions

Type	Name	Description
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
BIOLOGICAL	Placebo	Administered by subcutaneous injection in the deltoid region of the upper arm

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-09-07
• First posted: 2016-08-25
• Last updated: 2018-04-02

Locations

1 site across 1 country: United States