Evaluation of the Safety and Efficacy of a Single Dose of a Dengue Vaccine (TV005) in Healthy Adults

PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

December 31, 2014

Primary Completion Date

November 30, 2016

Conditions
Dengue
Interventions
BIOLOGICAL

TV005

TV005 is a live attenuated recombinant tetravalent dengue virus vaccine. It will be administered as a 0.5 mL dose containing 10\^3 plaque forming units (PFUs) of each component (10\^3.3 PFUs/mL of rDEN1∆30, 10\^4.3 PFU/mL of rDEN2/4∆30(ME), 10\^3.3 PFU/mL of rDEN3∆30/31-7164 and 10\^3.3 PFU/mL of rDEN4∆30). It will be delivered by subcutaneous injection in the deltoid region of the upper arm.

BIOLOGICAL

Placebo

The placebo vaccine will be administered as a 0.5 mL dose delivered by subcutaneous injection in the deltoid region of the upper arm.

BIOLOGICAL

rDEN2∆30-7169

rDEN2∆30-7169 is a live recombinant attenuated DENV-2 candidate vaccine virus. It will be administered as a 0.5 mL dose containing 10\^3 PFUs of rDEN2∆30-7169. It will be delivered 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 Vaccine Testing Center, Burlington

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT02317900 - Evaluation of the Safety and Efficacy of a Single Dose of a Dengue Vaccine (TV005) in Healthy Adults | Biotech Hunter | Biotech Hunter