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Evaluate the Safety, Tolerability and Immunogenicity Study of GLS-5300 in Healthy Volunteers

NCT03721718 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-05-27

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

BIOLOGICAL

GLS-5300

\[Part A\] GLS-5300 0.3 mg at 0, 4, and 12 weeks (N=5) \[Part B\] GLS-5300 0.3 mg at 0, 4, and 12 weeks (N=5) GLS-5300 0.6 mg at 0, 4, and 12 weeks (N=25) GLS-5300 0.6 mg at 0 and 8 weeks (N=25)

DEVICE

Cellectra 2000 Electroporation

GLS-5300 administered ID followed by Cellectra 2000 Electroporation

Sponsors & Collaborators

  • Inovio Pharmaceuticals

    collaborator INDUSTRY

  • International Vaccine Institute

    collaborator OTHER

  • GeneOne Life Science, Inc.

    lead INDUSTRY

Principal Investigators

  • Joel Maslow, MD, PhD, MBA · GeneOne Life Science, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-28
Primary Completion
2019-05-30
Completion
2020-04-22

Countries

  • South Korea

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03721718 on ClinicalTrials.gov