drugset

drugset / Trial / NCT02421367

Study of Varying Injection Schedules of TDENV-PIV Vaccine With AS03B Adjuvant and Placebo in Healthy US Adults

NCT02421367 ↗

Phase 1/2 Completed 140 enrolled U.S. Army Medical Research and Development Command GlaxoSmithKline · collab Walter Reed Army Institute of Research (WRAIR) · collab

RandomizedParallel-groupSingle-blindPrevention

Summary

This study is being conducted to evaluate the safety and immunogenicity and antibody persistence of the candidate dengue vaccine.

Timeline

Start: 2015-08
Primary completion: 2016-12
Completion: 2018-03

Outcome

Met primary endpoint

paper Both primary immunogenicity objectives were demonstrated. PMID 32342848 ↗

Publications

Lin L, Lyke KE, Koren M, Jarman RG, Eckels KH, Lepine E, McArthur MA, Currier JR, Friberg H, Moris P, Keiser PB, De La Barrera R, Vaughn DW, Paris RM, Thomas SJ, Schmidt AC. Safety and Immunogenicity of an AS03B-Adjuvanted Inactivated Tetravalent Dengue Virus Vaccine Administered on Varying Schedules to Healthy U.S. Adults: A Phase 1/2 Randomized Study. Am J Trop Med Hyg. 2020 Jul;103(1):132-141. doi: 10.4269/ajtmh.19-0738. Epub 2020 Apr 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TDENV-PIV	Vaccine	1 ug	Intramuscular
Subject	TDENV-PIV	Vaccine	0.5 ml	Intramuscular

Indications