Evaluating the Safety and Effectiveness of a Dengue Virus Vaccine in Healthy Adults

PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

March 31, 2015

Study Completion Date

December 31, 2015

Conditions
Dengue
Interventions
BIOLOGICAL

TetraVax-DV-TV003

TetraVax-DV-TV003 is a live attenuated recombinant tetravalent dengue virus vaccine, which will be administered as a 0.5 mL dose containing 10\^3.0 plaque forming units (PFUs) each of DENV-1, DENV-2, DENV-3, and DENV-4. It will be delivered by subcutaneous injection in the deltoid region of the upper arm.

BIOLOGICAL

rDEN2∆30-7169

The challenge virus, rDEN2∆30-7169, is a live recombinant attenuated DENV-2 candidate vaccine virus and 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.

BIOLOGICAL

Placebo

The placebo vaccine is the vaccine diluent 1X L-15, which will be administered as a 0.5 mL dose delivered by subcutaneous injection in the deltoid region of the upper arm.

Trial Locations (2)

21205

Center for Immunization Research (CIR), Johns Hopkins Bloomberg 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

NCT02021968 - Evaluating the Safety and Effectiveness of a Dengue Virus Vaccine in Healthy Adults | Biotech Hunter | Biotech Hunter