Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

Phase I, Open-label, Dose Ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of GLS-5300, Administered IM Followed by Electroporation in Healthy Volunteers

Trial Profile

Phase I, Open-label, Dose Ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of GLS-5300, Administered IM Followed by Electroporation in Healthy Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 01 Sep 2019

At a glance

  • Drugs GLS 5300 (Primary)
  • Indications Middle East respiratory syndrome coronavirus
  • Focus Adverse reactions; First in man
  • Sponsors GeneOne Life Science
  • Most Recent Events

    • 25 Jul 2019 According to an Inovio Pharmaceuticals media release, positive results from this trial were published in The Lancet Infectious Diseases.
    • 12 Mar 2019 According to Inovio Pharmaceuticals media release, Inovio expects to have clinical data from several Phase 1 vaccine programs published multiple publications in 2019: Ebola vaccine; MERS vaccine; HIV; and ZIka vaccine study in Puerto Rico.
    • 31 Jul 2018 Status changed from active, no longer recruiting to completed.

Trial Overview

Purpose

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.

Primary Endpoints

Mean change from baseline in safety laboratory measures

safety_issue: Yes
time_frame: Day0 through Week 60

Incidence of solicited adverse events after vaccination

safety_issue: Yes
time_frame: Day0 through Week 60

Incidence of unsolicited adverse events after vaccination

safety_issue: Yes
time_frame: Day0 through Week 60

Incidence of serious adverse events

safety_issue: Yes
time_frame: Day0 through Week 60

Other Endpoints

Binding antibody response to S protein

safety_issue: No
time_frame: Day0 through Week 60 following the first dose

Neutralizing antibody response to S protein

safety_issue: No
time_frame: Day0 through Week 60 following the first dose

T cell response

safety_issue: No
time_frame: Day 0 through Week 60 following the first dose [1]

Diseases Treated

Indication Qualifiers Patient Segments
Middle East respiratory syndrome coronavirus prevention -

Subjects

  • Subject Type patients
  • Number

    Planned: 75

    Actual: 75

  • Sex male & female
  • Age Group 18-50 years; adult

Patient Inclusion Criteria

1. Age 18-50 years; military, civilian, male and female. 2. Able to provide consent to participate and having signed an Informed Consent Form. 3. Able and willing to comply with all study procedures. 4. 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. 5. 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; 6. Normal screening ECG or screening ECG with no clinically significant findings; 7. Screening labs must be within normal limits or have only Grade 0-1 findings; 8. No history of clinically significant immunosuppressive or autoimmune disease. 9. 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). 10. Willing to allow storage and future use of samples for MERS CoV related research

Patient Exclusion Criteria

1. Administration of an investigational compound either currently or within 30 days of first dose; 2. Previous receipt of an investigational product for the treatment or prevention of MERS CoV except if participant is verified to have received placebo; 3. Previous infection with MERS CoV as assessed by self report and solicited exposure history; 4. Administration of any vaccine within 4 weeks of first dose; 5. A BMI greater than or equal to 35; 6. Administration of any monoclonal or polyclonal antibody product within 4 weeks of the first dose; 7. Administration of any blood product within 3 months of first dose; 8. Pregnancy or breast feeding or have plans to become pregnant during the course of the study; 9. 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; 10. Positive serologic test for hepatitis C (exception: successful treatment with confirmation of sustained virologic response); 11. Baseline evidence of kidney disease as measured by creatinine greater than 1.5 (CKD Stage II or greater); 12. Baseline screening lab(s) with Grade 2 or higher abnormality; 13. Chronic liver disease or cirrhosis; 14. Immunosuppressive illness including hematologic malignancy, history of solid organ or bone marrow transplantation; 15. 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); 16. Current or anticipated treatment with TNF-α inhibitors such as infliximab, adalimumab, etanercept; 17. Prior major surgery or any radiation therapy within 4 weeks of group assignment; 18. Any pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome; 19. Presence of a cardiac pacemaker or automatic implantable cardioverter defibrillator (AICD); 20. Metal implants within 20 cm of the planned site(s) of injection; 21. Presence of keloid scar formation or hypertrophic scar as a clinically significant medical condition at the planned site(s) of injection. 22. Prisoner or participants who are compulsorily detained (involuntary incarceration) for treatment of either a physical or psychiatric illness; 23. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements or assessment of immunologic endpoints; or 24. Tattoos covering the injection site area h 25. Any illness or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint.

Trial Details

Identifiers

Identifier Owner
NCT02670187 ClinicalTrials.gov: US National Institutes of Health
WRAIR2274 -

Organisations

  • Sponsors GeneOne Life Science
  • Affiliations GeneOne Life Science; Inovio Pharmaceuticals

Trial Dates

  • Initiation Dates

    Planned : 01 Dec 2015

    Actual : 01 Feb 2016

  • Primary Completion Dates

    Planned : 01 May 2017

    Actual : 01 May 2017

  • End Dates

    Planned : 01 Sep 2017

    Actual : 01 Sep 2017

Other Details

  • Design open; parallel; prospective
  • Phase of Trial Phase I
  • Location USA
  • Focus Adverse reactions; First in man

Interventions

Drugs Route Formulation
GLS 5300Primary Drug Intramuscular Injection

GLS-5300

GLS-5300 at 0.67 mg DNA/dose
Biological: GLS-5300

GLS-5300 at 2 mg DNA/dose

GLS-5300 at 2 mg DNA/dose
Biological: GLS-5300

GLS-5300 at 6 mg DNA/dose

GLS-5300 at 6 mg DNA/dose
Biological: GLS-5300

Results

Adverse events

Interim results from the phase I trial demonstrated that the vaccine was well tolerated and no significant safety concerns were noted to date [2] .

Immunogenicity

Interim results from phase I trial in healthy adult volunteers receiving INO 4800 demonstrated that 94% of participants achieved immunological response. One participant in the 1.0 mg dose cohort and two participants in the 2.0 mg dose cohort were excluded in the immune analyses as they tested positive for COVID-19 immune responses at study entry, indicating prior infection.

Updated data from a phase I trial demonstrated that antibody responses by ELISA in 94% of subjects at week 14 (two weeks post-third dose). Also, broad-based t cell responses were observed in 88% of participants. No statistically significant dose-dependent differences in antibody response rates (91%, 95%, and 95% at doses of 0.67, 2, and 6 mg, respectively) were reported. Durable antibody responses to the vaccine were also maintained through 60 weeks following dosing. Earlier results demonstrated that after a three dose vaccine regimen with GLS 5300 intramuscular, high levels of binding antibodies were measured in 92% (57 of 62) of evaluated subjects. Earlier reported interim results showed that single or two doses of the vaccine generated a robust antibody response in 84% or 44% of evaluated participants, respectively. Significant antigen-specific cytotoxic T-lymphocyte (CTL) responses were observed and 98% of subjects generated an antibody and/or T cell response against the MERS vaccine. Results were presented from the 75 healthy volunteers [3] [4] [2] .

Publications

  1. Inovio Pharmaceuticals. Inovio Reports New Positive Clinical Data on Vaccine Advances in the Fight Against Emerging Infectious Diseases. Media-Rel 2017;.

    Media Release
  2. Inovio Pharmaceuticals. Inovios MERS Vaccine Generates High Levels of Antibodies and Induces Broad-based T Cell Responses in Phase 1 Study. Media-Rel 2018;.

    Media Release
  3. Inovio Pharmaceuticals. Inovio Awarded up to $56 Million from CEPI to Advance DNA Vaccines Against Lassa Fever and MERS. Media-Rel 2018;.

    Media Release
  4. Modjarrad K, Roberts CC, Mills KT, Castellano AR, Paolino K, Muthumani K, et al. 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;19(9):1013-1022.

    PubMed | CrossRef Fulltext

Authors

Author Total Publications First Author Last Author
Bagarazzi M 1 - -
Boyer J 1 - -
Castellano AR 1 - -
Choi H 1 - -
Darden JM 1 - -
Duperret EK 1 - -
Inovio Pharmaceuticals 3 3 3
Jeong M 1 - -
Kane D 1 - -
Kim KY 1 - -
Kobinger G 1 - -
Kudchodkar SB 1 - -
Lamarre C 1 - -
Lee H 1 - -
Maslow JN 1 - 1
May JM 1 - -
Michael NL 1 - -
Mills KT 1 - -
Modjarrad K 1 1 -
Muthumani K 1 - -
Oh MD 1 - -
Paolino K 1 - -
Parikh AP 1 - -
Park YK 1 - -
Patel A 1 - -
Racine T 1 - -
Remigio C 1 - -
Reuschel EL 1 - -
Robb ML 1 - -
Roberts CC 1 - -
Scott PT 1 - -
Thomas SJ 1 - -
Weiner DB 1 - -
White S 1 - -
Wise MC 1 - -
Zaidi FI 1 - -

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Amy Castellano
1-301-319-9850
amy.r.castellano.ctr@mail.mil
show details
-
Kayvon Modjarrad, MD, PhD
1-301-500-3623
Usarmy.detrick.medcom-wrair.mbx.clinical-trials@mail.mil
show details
Walter Reed Army Institute of Research (WRAIR)
-

Centres

Centre Name Location Trial Centre Country
-
-
-
GeneOne Life Science, Inc.
-
-
Inovio Pharmaceuticals
-
-
Walter Reed Army Institute of Research (WRAIR)
-
-
Walter Reed Institute of Research Silver Spring, Maryland USA

Trial History

Event Date Event Type Comment
01 Sep 2019 Results Results published in The Lancet Infectious Diseases Updated 04 Jul 2020
25 Jul 2019 Results According to an Inovio Pharmaceuticals media release, positive results from this trial were published in The Lancet Infectious Diseases. Updated 29 Jul 2019
12 Mar 2019 Other trial event According to Inovio Pharmaceuticals media release, Inovio expects to have clinical data from several Phase 1 vaccine programs published multiple publications in 2019: Ebola vaccine; MERS vaccine; HIV; and ZIka vaccine study in Puerto Rico. Updated 19 Mar 2019
11 Jan 2019 Other trial event Last checked against ClinicalTrials.gov record. Updated 11 Jan 2019
31 Jul 2018 Status change - completed Status changed from active, no longer recruiting to completed. Updated 11 Aug 2018
27 Jun 2018 Results According to an Inovio Pharmaceuticals media release, data from this trial was presented at the WHO-IVI Joint Symposium for MERS-CoV Vaccine Development. Updated 04 Jul 2018
27 Jun 2018 Results Results presented in the Inovio Pharmaceuticals media release. Updated 04 Jul 2018
11 Apr 2018 Results Results published in the Inovio Pharmaceuticals media release. Updated 16 Apr 2018
04 Jan 2018 Other trial event According to ClinicalTrials.gov, the recruitment status of this study is unknown because the information has not been verified recently (last verified Jul 2016). Updated 04 Jan 2018
23 Feb 2017 Results According to an Inovio Pharmaceuticals media release, positive Clinical Data was presented at the Coalition for Epidemic Preparedness Innovation (CEPI) 1st Scientific Meeting. Updated 08 Mar 2017
23 Feb 2017 Interim results Interim results published in the Inovio Pharmaceuticals Media Release. Updated 03 Mar 2017
06 Dec 2016 Other trial event According to an Inovio Pharmaceuticals media release, interim data from this study is expected in early 2017 and publish the full data set in peer reviewed journals. Updated 13 Dec 2016
08 Aug 2016 Other trial event According to an Inovio Pharmaceuticals media release, the company expects to report interim immune response and safety data from this trial in the fourth quarter of 2016. Updated 31 Aug 2016
26 Jul 2016 Status change - active, no longer recruiting Status changed from recruiting to active, no longer recruiting. Updated 29 Jul 2016
17 Feb 2016 Other trial event New source identified and integrated (ClinicalTrials.gov NCT02670187). Updated 17 Feb 2016
28 Jan 2016 Status change - recruiting According to an Inovio Pharmaceuticals media release, status changed from planning to recruiting. Updated 29 Jan 2016
19 Nov 2015 Other trial event According to GeneOne Life Science media release, the U.S. FDA has announced the approval of this trial as a first-in-human study. Updated 23 Nov 2015
21 Oct 2015 New trial record New trial record Updated 21 Oct 2015
19 Oct 2015 Other trial event According to a company media release, GeneOne Life Science plans to initiate this study before the end of 2015. Updated 21 Oct 2015

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. Inovio Pharmaceuticals. Inovio Reports New Positive Clinical Data on Vaccine Advances in the Fight Against Emerging Infectious Diseases. Media-Rel 2017;.

    Media Release
  3. Inovio Pharmaceuticals. Inovio's Positive First-in-Human MERS Vaccine Results Published in The Lancet Infectious Diseases. Media-Rel 2019;.

    Media Release
  4. Inovio Pharmaceuticals. Inovios MERS Vaccine Generates High Levels of Antibodies and Induces Broad-based T Cell Responses in Phase 1 Study. Media-Rel 2018;.

    Media Release
  5. Inovio Pharmaceuticals. Inovio MERS Vaccine Development to be Expanded with Funding from International Vaccine Institute. Media-Rel 2016;.

    Media Release
  6. GeneOne Life Science. GeneOne Life Science and Inovio Pharmaceuticals MERS Vaccine Approved for First-in-Human Study. Media-Rel 2015;.

    Media Release
  7. Inovio Pharmaceuticals. Inovio Pharmaceuticals and GeneOne Life Science Initiate Patient Recruitment for MERS Vaccine Trial. Media-Rel 2016;.

    Media Release
  8. Inovio Pharmaceuticals. Inovio Pharmaceuticals Reports 2018 Fourth Quarter and Year-End Financial Results. Media-Rel 2019;.

    Media Release
  9. Inovio Pharmaceuticals. Inovio Awarded up to $56 Million from CEPI to Advance DNA Vaccines Against Lassa Fever and MERS. Media-Rel 2018;.

    Media Release
  10. Modjarrad K, Roberts CC, Mills KT, Castellano AR, Paolino K, Muthumani K, et al. 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;19(9):1013-1022.

    PubMed | CrossRef Fulltext
  11. GeneOne Life Science. Inovio and Partner Advance MERS Vaccine. Media-Rel 2015;.

    Media Release
  12. Inovio Pharmaceuticals. Inovio Pharmaceuticals Reports 2016 Second Quarter Financial Results. Media-Rel 2016;.

    Media Release
Back to top