NCT02670187

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Feb 2016

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

1.2 years

First QC Date

January 27, 2016

Last Update Submit

January 8, 2019

Conditions

Healthy

Keywords

MERS CoVMERS-CoVMiddle East Respiratory SyndromeMERSDNA Vaccine

Outcome Measures

Primary Outcomes (4)

  • Mean change from baseline in safety laboratory measures

    Day0 through Week 60

  • Incidence of solicited adverse events after vaccination

    Day0 through Week 60

  • Incidence of unsolicited adverse events after vaccination

    Day0 through Week 60

  • Incidence of serious adverse events

    Day0 through Week 60

Secondary Outcomes (3)

  • Binding antibody response to S protein

    Day0 through Week 60 following the first dose

  • Neutralizing antibody response to S protein

    Day0 through Week 60 following the first dose

  • T cell response

    Day 0 through Week 60 following the first dose

Study Arms (3)

GLS-5300

EXPERIMENTAL

GLS-5300 at 0.67 mg DNA/dose

Biological: GLS-5300

GLS-5300 at 2 mg DNA/dose

EXPERIMENTAL

GLS-5300 at 2 mg DNA/dose

Biological: GLS-5300

GLS-5300 at 6 mg DNA/dose

EXPERIMENTAL

GLS-5300 at 6 mg DNA/dose

Biological: GLS-5300

Interventions

GLS-5300BIOLOGICAL
GLS-5300GLS-5300 at 2 mg DNA/doseGLS-5300 at 6 mg DNA/dose

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-50 years; military, civilian, male and female.
  • Able to provide consent to participate and having signed an Informed Consent Form.
  • Able and willing to comply with all study procedures.
  • Women of child-bearing potential agree to remain sexually abstinent, use medically effective contraception (oral contraception, barrier methods, spermicide, etc.) or have a partner who is sterile from enrollment to 3 months following the last injection, or have a partner who is unable to induce pregnancy.
  • Sexually active men who are considered sexually fertile must agree to use either a barrier method of contraception during the study, and agree to continue the use for at least 3 months following the last injection, or have a partner who is permanently sterile or unable to become pregnant;
  • Normal screening ECG or screening ECG with no clinically significant findings;
  • Screening labs must be within normal limits or have only Grade 0-1 findings;
  • No history of clinically significant immunosuppressive or autoimmune disease.
  • Not currently or within the previous 4 weeks taking immunosuppressive agents (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or corticosteroids at a dose less than 20 mg/day).
  • Willing to allow storage and future use of samples for MERS CoV related research

You may not qualify if:

  • Administration of an investigational compound either currently or within 30 days of first dose;
  • Previous receipt of an investigational product for the treatment or prevention of MERS CoV except if participant is verified to have received placebo;
  • Previous infection with MERS CoV as assessed by self report and solicited exposure history;
  • Administration of any vaccine within 4 weeks of first dose;
  • A BMI greater than or equal to 35;
  • Administration of any monoclonal or polyclonal antibody product within 4 weeks of the first dose;
  • Administration of any blood product within 3 months of first dose;
  • Pregnancy or breast feeding or have plans to become pregnant during the course of the study;
  • History of positive serologic test for HIV, hepatitis B surface antigen (HBsAg); or any potentially communicable infectious disease as determined by the Principal Investigator or Medical Monitor;
  • Positive serologic test for hepatitis C (exception: successful treatment with confirmation of sustained virologic response);
  • Baseline evidence of kidney disease as measured by creatinine greater than 1.5 (CKD Stage II or greater);
  • Baseline screening lab(s) with Grade 2 or higher abnormality;
  • Chronic liver disease or cirrhosis;
  • Immunosuppressive illness including hematologic malignancy, history of solid organ or bone marrow transplantation;
  • Current or anticipated concomitant immunosuppressive therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or corticosteroids at a dose less than 20 mg/day);
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walter Reed Institute of Research

Silver Spring, Maryland, 20910, United States

Location

Related Publications (1)

  • 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.

    PMID: 31351922DERIVED

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Kayvon Modjarrad, MD, PhD

    Walter Reed Army Institute of Research (WRAIR)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2016

First Posted

February 1, 2016

Study Start

February 1, 2016

Primary Completion

May 1, 2017

Study Completion

September 1, 2017

Last Updated

January 9, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will share

Locations

US(1)