Evaluating the Safety and Immune Response to Two Admixtures of a Tetravalent Dengue Virus Vaccine

PHASE1CompletedINTERVENTIONAL
Enrollment

112

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

March 31, 2014

Study Completion Date

March 31, 2014

Conditions
Dengue
Interventions
BIOLOGICAL

TetraVax-DV Vaccine - Admixture TV003

One subcutaneous injection at Day 0 and Day 180 of a live attenuated recombinant TetraVax-DV vaccine, Admixture TV003 (10\^3 PFU of rDEN1Δ30, 10\^3 PFU of rDEN2/4Δ30(ME), 10\^3 PFU of rDEN3Δ30/31-7164, and 10\^3 PFU of rDEN4Δ30)

BIOLOGICAL

TetraVax-DV Vaccine - Admixture TV005

One subcutaneous injection at Day 0 and Day 180 of a live attenuated recombinant TetraVax-DV vaccine, Admixture TV005 (10\^3 PFU of rDEN1Δ30, 10\^4 PFU of rDEN2/4Δ30(ME), 10\^3 PFU of rDEN3Δ30/31-7164, and 10\^3 PFU of rDEN4Δ30)

BIOLOGICAL

Placebo

One subcutaneous injection at Day 0 and Day 180 of placebo

Trial Locations (3)

21205

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

05401

Fletcher Allen Health Care (FAHC), General Clinical Research Center (GCRC), Burlington

05405

University of Vermont Vaccine Testing Center, Burlington

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT01436422 - Evaluating the Safety and Immune Response to Two Admixtures of a Tetravalent Dengue Virus Vaccine | Biotech Hunter | Biotech Hunter