A Phase 1 Trial of the Walter Reed Army Institute of Research (WRAIR) Dengue Virus Serotype-1 Purified Inactivated Vaccine (DENV-1 PIV) in Flavivirus Antibody Naïve Adults

NCT01502735 Phase 1 COMPLETED

This is a phase 1 study to evaluate the safety of a vaccine (DENV-1 PIV) for the prevention of dengue fever.

Details

Lead sponsor	U.S. Army Medical Research and Development Command
Phase	Phase 1
Status	COMPLETED
Enrolment	20
Start date	2011-12
Completion	2013-09

Conditions

• Dengue Fever

Interventions

• DENV-1 PIV, 2.5 µg
• DENV-1 PIV, 5 µg

Primary outcomes

• Number of subjects with solicited adverse events (AEs) from study day 0 to 90 — Up to 90 days
• Number of subjects with unsolicited AEs from study day 0 to 90 — Up to 90 days
• Number of subjects who experience serious adverse events (SAEs) during the study period — Up to 360 Days

Countries

United States