NCT03416036 - Evaluation of the Efficacy of the Live Attenuated Tetravalent Dengue Vaccine Against DENV-2 and DENV-3 Challenge | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

November 28, 2017

Primary Completion Date

January 17, 2019

Study Completion Date

June 4, 2019

Conditions

Dengue

Interventions

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

Trial Locations (2)

21205

Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore

05405

Vaccine Testing Center, University of Vermont, Burlington

All Listed Sponsors

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH