NCT03416036

Evaluation of the Efficacy of the Live Attenuated Tetravalent Dengue Vaccine Against DENV-2 and DENV-3 Challenge

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the ability of a single dose of a live attenuated recombinant tetravalent dengue vaccine (TetraVax-DV-TV003, referred to as TV003) to protect against infection with a controlled human infection strain of either DENV-2 (rDEN2Δ30-7169) or DENV-3 (rDEN3Δ30) in adults 18 to 50 years of age with no history of previous flavivirus infection.

Detailed description

This study will evaluate the ability of a single dose of a live attenuated recombinant tetravalent dengue vaccine (TetraVax-DV-TV003, referred to as TV003) to protect against infection with a controlled human infection strain of either DENV-2 (rDEN2Δ30-7169) or DENV-3 (rDEN3Δ30) in adults 18 to 50 years of age with no history of previous flavivirus infection. Participants will be randomly assigned to receive either TV003 or placebo at study entry (Day 0) and either rDEN2Δ30-7169 or rDEN3Δ30 on Day 28. Study visits will occur on Days 0, 4, 6, 8, 10, 12, 14, 16, 21, 28, 32, 34, 36, 38, 40, 42, 44, 49, 56, 84, 118, and 208. Visits may include a physical examination and blood collection.

Conditions

• Dengue

Interventions

Type	Name	Description
BIOLOGICAL	TetraVax-DV-TV003 (TV003)	TV003 contains 10\^3.3 plaque-forming units (PFU)/mL of rDEN1Δ30, 10\^3.3 PFU/mL of rDEN2/4Δ30(ME), 10\^3.3 PFU/mL of rDEN3Δ30/31-7164, and 10\^3.3 PFU/mL of rDEN4Δ30. Administered by subcutaneous injection in the deltoid region of the upper arm
BIOLOGICAL	rDEN2Δ30-7169 (DENV-2)	Administered at a dose of 10\^3 PFU by subcutaneous injection in the deltoid region of the upper arm
BIOLOGICAL	rDEN3Δ30 (DENV-3)	Administered at a dose of 10\^3 PFU 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: 2017-11-28
• Primary completion: 2019-01-17
• Completion: 2019-06-04
• First posted: 2018-01-30
• Last updated: 2020-01-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study