Phase I, Open Label Dose Ranging Safety Study of GLS-5300 in Healthy Volunteers

Phase 1 Completed 75 enrolled GeneOne Life Science, Inc. Inovio Pharmaceuticals · collab Walter Reed Army Institute of Research (WRAIR) · collab

Non-randomizedParallel-groupOpen-labelPrevention

Summary

The Middle East Respiratory Syndrome Coronavirus (MERS CoV), a virus related to Severe Acute respiratory syndrome coronavirus (SARS CoV), was first recognized as a cause of severe pulmonary infection in 2012. Infection with MERS CoV has been diagnosed in more than 1600 individuals with a mortality rate between 35% and 40%. GLS-5300 is a DNA plasmid vaccine that expresses the MERS CoV spike (S) glycoprotein. This study will evaluate the safety of GLS-5300 at one of three dose levels following a three-injection vaccination regimen followed by electroporation. The study will also assess immune responses over a 1 year period with respect to the generation of antibody and cellular responses.

Timeline

Start: 2016-02
Primary completion: 2017-05
Completion: 2017-09

Publications

Modjarrad K, Roberts CC, Mills KT, Castellano AR, Paolino K, Muthumani K, Reuschel EL, Robb ML, Racine T, Oh MD, Lamarre C, Zaidi FI, Boyer J, Kudchodkar SB, Jeong M, Darden JM, Park YK, Scott PT, Remigio C, Parikh AP, Wise MC, Patel A, Duperret EK, Kim KY, Choi H, White S, Bagarazzi M, May JM, Kane D, Lee H, Kobinger G, Michael NL, Weiner DB, Thomas SJ, Maslow JN. Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial. Lancet Infect Dis. 2019 Sep;19(9):1013-1022. doi: 10.1016/S1473-3099(19)30266-X. Epub 2019 Jul 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GLS-5300	Vaccine	0.67 mg	Intramuscular
Subject	GLS-5300	Vaccine	2 mg	Intramuscular
Subject	GLS-5300	Vaccine	6 mg	Intramuscular

Indications

No indication recorded.