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

NCT02670187 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2019-01-09

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

BIOLOGICAL

GLS-5300

Sponsors & Collaborators

  • Inovio Pharmaceuticals

    collaborator INDUSTRY

  • Walter Reed Army Institute of Research (WRAIR)

    collaborator FED

  • GeneOne Life Science, Inc.

    lead INDUSTRY

Principal Investigators

  • Kayvon Modjarrad, MD, PhD · Walter Reed Army Institute of Research (WRAIR)

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-05-31
Completion
2017-09-30

Countries

  • United States

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 NCT02670187 on ClinicalTrials.gov