Evaluating the Safety and Protective Efficacy of a Single Dose of the Live Attenuated Tetravalent Dengue Vaccine TV005 to Protect Against Infection With rDEN3Δ30

PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

August 31, 2016

Primary Completion Date

November 30, 2017

Study Completion Date

November 30, 2017

Conditions
Dengue
Interventions
BIOLOGICAL

TetraVax-DV-TV005

TetraVax-DV-TV005 contains 10\^3.3 plaque forming units (PFU)/mL of rDEN1Δ30, 10\^4.3 PFU/mL of rDEN2/4Δ30(ME), 10\^3.3 PFU/mL of rDEN3Δ30/31-7164, and 10\^3.3 PFU/mL of rDEN4Δ30. The vaccine is administered in 0.5 mL containing 10\^3.0 PFU of each component with the exception of rDEN2/4Δ30 that is given at a dose of 10\^4 PFU. TetraVax-DV-TV005 is administered by subcutaneous injection in the deltoid region of the upper arm.

BIOLOGICAL

rDEN3Δ30

Administered at a dose of 10\^4 PFU by subcutaneous injection in the deltoid region of the upper arm.

BIOLOGICAL

Placebo

Administered at a volume of 0.5 mL by subcutaneous injection in the deltoid region of the upper arm.

Trial Locations (2)

21205

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

05405

University of Vermont Testing Center, Burlington

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT02873260 - Evaluating the Safety and Protective Efficacy of a Single Dose of the Live Attenuated Tetravalent Dengue Vaccine TV005 to Protect Against Infection With rDEN3Δ30 | Biotech Hunter | Biotech Hunter