drugset / Trial / NCT03721718
Evaluate the Safety, Tolerability and Immunogenicity Study of GLS-5300 in Healthy Volunteers
Phase 1/2
Completed
60 enrolled
GeneOne Life Science, Inc.
Inovio Pharmaceuticals · collabInternational Vaccine Institute · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
The Middle East Respiratory Syndrome Coronavirus (MERS CoV), is a cause of severe and highly fatal lower respiratory tract infection, first identified in 2012. As of August 2018, there have been 2229 cases reported with a case fatality rate \>35%. In 2015 an individual returning to South Korea served as the index case for an outbreak of 186 individuals, of who, \>20% died. GLS-5300 is a DNA plasmid vaccine that expresses the MERS CoV spike (S) glycoprotein. This Phase I/IIa study will evaluate the safety, tolerability and immunogenicity of GLS-5300 administered intradermally (ID) followed by electroporation at 0.3 and 0.6 mg/dose assessing 2 and 3-dose regimens.
Timeline
- Start
- 2018-08-28
- Primary completion
- 2019-05-30
- Completion
- 2020-04-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GLS-5300 | Vaccine | 0.3 mg | Intrathecal |
| Subject | GLS-5300 | Vaccine | 0.6 mg | Intrathecal |
Indications
No indication recorded.