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Phase I, Open-label, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of GLS-5700 Administered ID Followed by EP in Dengue Virus-Naïve Adults

Trial Profile

Phase I, Open-label, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of GLS-5700 Administered ID Followed by EP in Dengue Virus-Naïve Adults

Completed
Phase of Trial: Phase I

Latest Information Update: 08 Aug 2018

At a glance

  • Drugs GLS 5700 (Primary)
  • Indications Zika virus infection
  • Focus Adverse reactions; First in man
  • Sponsors GeneOne Life Science
  • Most Recent Events

    • 31 Jul 2018 Status changed from active, no longer recruiting to completed.
    • 08 Oct 2017 Results presented at the IDWeek 2017
    • 04 Oct 2017 Interim analysis results at 14 weeks, published in the New England Journal of Medicine.

Trial Overview

Purpose

This dose-ranging study will investigate the effect of Zika vaccine in patients with Zika-virus-infection.

Primary Endpoints

Mean change from baseline in safety laboratory measures

safety_issue: Yes
time_frame: Day 0 through Week 60

Incidence of solicited adverse events after vaccination

safety_issue: Yes
time_frame: Day 0 through Week 60

Incidence of unsolicited adverse events after vaccination

safety_issue: Yes
time_frame: Day 0 through Week 60

Incidence of serious adverse events

safety_issue: Yes
time_frame: Day 0 through Week 60

Other Endpoints

Binding antibody titers to Zika envelope

safety_issue: No
time_frame: Day 0 through Week 60 following first dose

Neutralizing antibody response against Zika virus

safety_issue: No
time_frame: Day 0 through Week 60 following first dose

T cell response

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

Diseases Treated

Indication Qualifiers Patient Segments
Zika virus infection prevention, treatment -

Subjects

  • Subject Type volunteers
  • Number

    Planned: 40

    Actual: 40

  • Sex male & female
  • Age Group 18-65 years (Median 38 years); adult

Patient Inclusion Criteria

1. Age 18-65 years; 2. Able to provide consent to participate and having signed an Informed Consent Form (ICF); 3. Able and willing to comply with all study procedures; 4. Women of child-bearing potential agree to 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 medically 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 is medically unable to become pregnant; 6. Normal screening ECG or screening ECG with no clinically significant findings; 7. Screening laboratory must be within normal limits or have only Grade 0-1 findings; 8. No history of clinically significant immunosuppressive or autoimmune disease. 9. No history of dengue virus vaccination or illness; no history of yellow fever vaccination. 10. Dengue seronegative at baseline by screening laboratory evaluation 11. 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).

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 Zika virus except if participant is verified to have received placebo; 3. Administration of any vaccine within 4 weeks of first dose; 4. Administration of any monoclonal or polyclonal antibody product within 4 weeks of the first dose 5. Administration of any blood product within 3 months of first dose; 6. Pregnancy or breast feeding or plans to become pregnant during the course of the study; 7. Positive serologic result for dengue virus (any serotype) or history of receipt of either dengue virus or yellow fever virus vaccination at any time in the past; 8. 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; 9. Positive serologic test for hepatitis C (exception: successful treatment with confirmation of sustained virologic response); 10. Baseline evidence of kidney disease as measured by creatinine greater than 1.5 (CKD Stage II or greater); 11. Baseline screening lab(s) with Grade 2 or higher abnormality, except for Grade 2 creatinine; 12. Chronic liver disease or cirrhosis; 13. Immunosuppressive illness including hematologic malignancy, history of solid organ or bone marrow transplantation; 14. 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); 15. Current or anticipated treatment with TNF-α inhibitors such as infliximab, adalimumab, etanercept; 16. Prior major surgery or any radiation therapy within 4 weeks of group assignment; 17. Any pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome; 18. Presence of a cardiac pacemaker or automatic implantable cardioverter defibrillator (AICD) 19. Metal implants within 20 cm of the planned site(s) of injection; 20. Presence of keloid scar formation or hypertrophic scar as a clinically significant medical condition at the planned site(s) of injection. 21. Prisoner or participants who are compulsorily detained (involuntary incarceration) for treatment of either a physical or psychiatric illness; 22. 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 23. Not willing to allow storage and future use of samples for Zika virus related research 24. 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
NCT02809443 ClinicalTrials.gov: US National Institutes of Health
Zika001 -

Organisations

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

Trial Dates

  • Initiation Dates

    Planned : 01 Jun 2016

    Actual : 01 Jul 2016

  • Primary Completion Dates

    Planned : 01 Nov 2017

    Actual : 01 Nov 2017

  • End Dates

    Planned : 01 Dec 2017

    Actual : 01 Dec 2017

Other Details

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

Interventions

Drugs Route Formulation
GLS 5700Primary Drug Intradermal Injection

GLS-5700 at 1 mg

DNA/dose
Biological: GLS-5700 (GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus)

GLS-5700 at 2 mg

DNA/dose
Biological: GLS-5700 (GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus)

Results

Adverse events

Results from the phase I ZIKA-001 study showed that the GLS 5700 vaccine was well tolerated and no significant safety concerns were observed.

Immunogenicity

In the phase I ZIKA-001 trial, high levels of binding antibodies were measured in 100% of evaluated subjects, after three doses of GLS 5700 vaccine regimen, and in 95% after two doses of vaccine. Further, neutralizing antibodies were observed in more than 95% of the serum samples that were assayed on neuronal-cell targets. Earlier reported data showed a robust antibody response in 95% and 40% of the volunteers by two doses or a single dose of vaccine, respectively. The parallel-assignment trial enrolled 40 volunteers for the prevention of zika virus infection [2] [3] .

Publications

  1. Inovio Pharmaceuticals. Inovio Zika Vaccine Prevents Persistence of Virus and Damage in Male Reproductive Tract in Pre-Clinical Study. Media-Rel 2017;.

    Media Release
  2. Tebas P, Roberts CC, Muthumani K, Reuschel EL, Kudchodkar SB, Zaidi FI, et al. Safety and Immunogenicity of an Anti-Zika Virus DNA Vaccine - Preliminary Report. N-Engl-J-Med 2017;.

    PubMed | CrossRef Fulltext
  3. Inovio Pharmaceuticals. Inovio Reports New Positive Clinical Data on Vaccine Advances in the Fight Against Emerging Infectious Diseases. Media-Rel 2017;.

    Media Release
  4. Tebas P, Roberts CC, Muthumani K, Reuschel E, White S, Khan AS, et al. ZIKA-001: Safety and Immunogenicity of an Engineered DNA Vaccine Against ZIKA virus infection. IDW-2017 2017; abstr. 839.

    Available from: URL: https://idsa.confex.com/idsa/2017/webprogram/Paper66641.html
  5. Inovio Pharmaceuticals. Inovios Zika VaccineGenerates Robust Immune Responses in First Human Study. Media-Rel 2016;.

    Media Release

Authors

Author Total Publications First Author Last Author
Bagarazzi M 1 - -
Boyer J 2 - -
Choi H 2 - -
Inovio Pharmaceuticals 3 3 3
Khan AS 2 - -
Kobinger GP 2 - -
Krieger D 2 - -
Kudchodkar S 1 - -
Kudchodkar SB 1 - -
Maslow J 1 - 1
Maslow JN 1 - 1
Muthumani K 2 - -
Park YK 2 - -
Racine T 2 - -
Remigio C 2 - -
Reuschel E 1 - -
Reuschel EL 1 - -
Roberts CC 2 - -
Spruill SE 1 - -
Tebas P 2 2 -
Trottier S 2 - -
Weiner D 1 - -
Weiner DB 1 - -
White S 2 - -
Zaidi F 1 - -
Zaidi FI 1 - -

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Celine Remigio
215-703-5843 cremigio@geneonels-us.com
show details
-
Joel Maslow, MD
215-703-5843 jmaslow@geneonels-us.com
show details
GeneOne Life Science
-

Centres

Centre Name Location Trial Centre Country
-
-
-
CHU de Québec -Université Laval hopital CHUL Centre de Recherche en infectiologie Quebec Canada
GeneOne Life Science
-
-
GeneOne Life Science, Inc.
-
-
Inovio Pharmaceuticals
-
-
Miami Research Associate Miami, Florida USA
University of Pennslyvania Philadelphia, Pennsylvania USA

Trial History

Event Date Event Type Comment
08 Aug 2018 Other trial event Last checked against ClinicalTrials.gov record. Updated 08 Aug 2018
31 Jul 2018 Status change - completed Status changed from active, no longer recruiting to completed. Updated 08 Aug 2018
08 Oct 2017 Results Results presented at the IDWeek 2017 Updated 24 Oct 2017
04 Oct 2017 Interim results Interim analysis results at 14 weeks, published in the New England Journal of Medicine. Updated 11 Oct 2017
07 Jun 2017 Results Results published in the Inovio Pharmaceuticals media release. Updated 13 Jun 2017
07 Mar 2017 Other trial event Planned primary completion date changed from 1 Nov 2016 to 1 Nov 2017. Updated 14 Mar 2017
07 Mar 2017 Completion date Planned End Date changed from 1 Nov 2017 to 1 Dec 2017. Updated 14 Mar 2017
07 Mar 2017 Status change - active, no longer recruiting Status changed from completed to active, no longer recruiting. Updated 14 Mar 2017
24 Feb 2017 Status change - completed Status changed from active, no longer recruiting to completed. Updated 02 Mar 2017
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 Results Results published in the Inovio Pharmaceuticals Media Release. Updated 08 Mar 2017
21 Dec 2016 Other trial event According to an Inovio Pharmaceuticals media release, based on this and other study (Zika001), company plans to meet with regulators to map out the most efficient path forward to bring our Zika vaccine to patients and help mitigate this widespread Zika outbreak that has expanded into the continental United States. Updated 27 Dec 2016
21 Dec 2016 Results Results published in an Inovio Pharmaceuticals media release. Updated 27 Dec 2016
29 Aug 2016 Other trial event According to an Inovio Pharmaceuticals media release, all the subjects in this study have been dosed and results are expected before the end of the year 2016. Updated 19 Sep 2016
29 Aug 2016 Status change - active, no longer recruiting Status changed from recruiting to active, no longer recruiting. Updated 10 Sep 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 in the fourth quarter of 2016. Updated 31 Aug 2016
26 Jul 2016 Other trial event According to Inovio Pharmaceuticals media release, the US FDA, Health Canada's Health Products and Food Branch has approved to conduct this study. Updated 02 Aug 2016
26 Jul 2016 Other trial event According to Inovio Pharmaceuticals media release, company expects to complete subject dosing and report interim results later this year. Updated 02 Aug 2016
26 Jul 2016 Other trial event According to Inovio Pharmaceuticals media release, company announced the dosing of the first subject in this trial. Updated 02 Aug 2016
12 Jul 2016 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 18 Jul 2016
29 Jun 2016 Other trial event New source identified and integrated. (ClinicalTrials.gov: US National Institutes of Health; NCT02809443). Updated 29 Jun 2016
20 Jun 2016 Other trial event According to Inovio Pharmaceuticals media release, company plans to dose first subjects in the next weeks and expect to report phase I interim results later this year. Updated 02 Aug 2016
20 Jun 2016 Other trial event According to Inovio Pharmaceuticals media release, company has received approval to initiate this study. Updated 23 Jun 2016
20 Jun 2016 Status change - not yet recruiting Status changed from planning to not yet recruiting, as per Inovio Pharmaceuticals media release. Updated 23 Jun 2016
19 Feb 2016 New trial record New trial record Updated 19 Feb 2016
17 Feb 2016 Other trial event According to Inovio Pharmaceuticals media release, company is planning to initiate this trial before the end of 2016 Updated 19 Feb 2016

References

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

    Available from: URL: http://clinicaltrials.gov
  2. Inovio Pharmaceuticals. Inovios Positive Zika Vaccine Clinical Study Data Published in New England Journal of Medicine. Media-Rel 2017;.

    Media Release
  3. Inovio Pharmaceuticals. Inovio Zika Vaccine Prevents Persistence of Virus and Damage in Male Reproductive Tract in Pre-Clinical Study. Media-Rel 2017;.

    Media Release
  4. Inovio Pharmaceuticals. Inovio Pharmaceuticals Zika VaccineProduces Robust Immune Responses in Non-Human Primates. Media-Rel 2016;.

    Media Release
  5. Tebas P, Roberts CC, Muthumani K, Reuschel EL, Kudchodkar SB, Zaidi FI, et al. Safety and Immunogenicity of an Anti-Zika Virus DNA Vaccine - Preliminary Report. N-Engl-J-Med 2017;.

    PubMed | CrossRef Fulltext
  6. Inovio Pharmaceuticals. Inovio Reports New Positive Clinical Data on Vaccine Advances in the Fight Against Emerging Infectious Diseases. Media-Rel 2017;.

    Media Release
  7. Inovio Pharmaceuticals. Inovio Pharmaceuticals Doses First Subject in Zika Vaccine Clinical Trial. Media-Rel 2016;.

    Media Release
  8. Inovio Pharmaceuticals. Inovio Launches Zika Vaccine Trial in Midst of Puerto Rico Epidemic to Explore Early Signals of Vaccine Efficacy. Media-Rel 2016;.

    Media Release
  9. Tebas P, Roberts CC, Muthumani K, Reuschel E, White S, Khan AS, et al. ZIKA-001: Safety and Immunogenicity of an Engineered DNA Vaccine Against ZIKA virus infection. IDW-2017 2017; abstr. 839.

    Available from: URL: https://idsa.confex.com/idsa/2017/webprogram/Paper66641.html
  10. Inovio Pharmaceuticals. Inovios Zika VaccineGenerates Robust Immune Responses in First Human Study. Media-Rel 2016;.

    Media Release
  11. Inovio Pharmaceuticals. Inovio Pharmaceuticals and GeneOne Life Science Receive Approval for First-in-Man Zika Vaccine Clinical Trial. Media-Rel 2016;.

    Media Release
  12. Inovio Pharmaceuticals. Inovio Pharmaceutical's DNA Vaccine for Zika Virus Induces Robust Immune Responses in Preclinical Study. Media-Rel 2016;.

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

    Media Release
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