A Phase 1 Evaluation of the Safety and Immunogenicity of the Recombinant Live Attenuated Tetravalent Dengue Virus Vaccine Admixtures TV003 and TV005 in Healthy Flavivirus-Naïve Adult Subjects

NCT01436422 Phase 1 COMPLETED

Dengue viruses can cause dengue fever and other serious health conditions, primarily affecting people living in tropical regions of the world. This study will evaluate the safety and immune responses to two formulations of a tetravalent dengue virus vaccine in healthy adults.

Details

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	COMPLETED
Enrolment	112
Start date	2011-08
Completion	2014-03

Conditions

• Dengue

Interventions

• TetraVax-DV Vaccine - Admixture TV003
• TetraVax-DV Vaccine - Admixture TV005
• Placebo

Primary outcomes

• Safety of two TetraVax-DV admixtures, as assessed by the frequency of vaccine-related adverse events (AEs), graded by severity — Measured through Day 360
• Immunogenicity of two TetraVax-DV admixtures, as assessed by neutralizing antibody titers to DEN1, DEN2, DEN3, and DEN4 — Measured through Day 180 after each vaccination
  Monovalent, bivalent, trivalent, and tetravalent seropositivity and seroconversion rates will be determined at 28, 56, and 90 days after each vaccination.
• Seropositivity in those vaccinees who remained seronegative to one or more DENV serotypes following the first vaccination and who recieved a second dose of vaccine given at Day 180 — Measured through Day 360

Countries

United States