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Phase I, Placebo-Controlled, Double-Blind Study To Evaluate The Safety, Tolerability, AND Immunogenicity Of GLS-5700, Administered ID Followed By Electroporation In Dengue Virus-Seropositive Adults

Trial Profile

Phase I, Placebo-Controlled, Double-Blind Study To Evaluate The Safety, Tolerability, AND Immunogenicity Of GLS-5700, Administered ID Followed By Electroporation In Dengue Virus-Seropositive Adults

Completed
Phase of Trial: Phase I

Latest Information Update: 12 Dec 2018

At a glance

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

    • 04 Dec 2018 Status changed from active, no longer recruiting to completed.
    • 13 Jun 2017 Planned End Date changed from 1 May 2018 to 1 Jun 2018.
    • 13 Jun 2017 Planned primary completion date changed from 1 Jun 2017 to 1 Oct 2017.

Trial Overview

Purpose

This trial is evaluating the safety, tolerability, and immunogenicity of GLS-5700. GLS-5700 is a synthetic DNA plasmid vaccine against the Zika virus.

Primary Endpoints

Mean change from baseline in safety laboratory measures

safety_issue: Yes
time_frame: Day 0 through Week 24

Incidence of solicited adverse events after vaccination

safety_issue: Yes
time_frame: Day 0 through Week 24

Incidence of unsolicited adverse events after vaccination

safety_issue: Yes
time_frame: Day 0 through Week 24

Incidence of serious adverse events

safety_issue: Yes
time_frame: Day 0 through Week 24

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

Mean change from baseline for safety measures and adverse events

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

Diseases Treated

Indication Qualifiers Patient Segments
Zika virus infection prevention -

Subjects

  • Subject Type volunteers
  • Number

    Planned: 160

    Actual: 160

  • Sex male & female
  • Age Group 18-65 years; adult

Patient Inclusion Criteria

- Age 18-65 years; - Able to provide consent to participate and having signed an Informed Consent Form (ICF); - Able and willing to comply with all study procedures; - 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. - 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 medically unable to become pregnant; - Seropositive for dengue virus infection. - 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, except that creatinine may grade 2 at baseline; - No history of clinically significant immunosuppressive or autoimmune disease. - No history of dengue virus vaccination; no history of yellow fever vaccination - 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 prednisone at a dose less than 10 mg/day, or steroid equivalent).

Patient Exclusion Criteria

- 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 Zika virus infection except if subject is verified to have received placebo; - Administration of any vaccine within 4 weeks of first dose; - 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; - Negative 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; - 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 prednisone at a dose equal to or greater than 10 mg/day, or steroid equivalent); - Current or anticipated treatment with TNF-α inhibitors such as infliximab, adalimumab, etanercept; - Prior major surgery or any radiation therapy within 4 weeks of group assignment; - Any pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome; - Presence of a cardiac pacemaker or automatic implantable cardioverter defibrillator (AICD) - Metal implants within 20 cm of the planned site(s) of injection; - Presence of keloid scar formation or hypertrophic scar as a clinically significant medical condition at the planned site(s) of injection. - Prisoner or subjects who are compulsorily detained (involuntary incarceration) for treatment of either a physical or psychiatric illness; - 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 - Not willing to allow storage and future use of samples for Zika virus related research - Any illness or condition that in the opinion of the investigator may affect the safety of the subject or the evaluation of any study endpoint.

Trial Details

Identifiers

Identifier Owner
NCT02887482 ClinicalTrials.gov: US National Institutes of Health
Zika002 -

Organisations

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

Trial Dates

  • Initiation Dates

    Actual : 01 Aug 2016

  • Primary Completion Dates

    Planned : 01 Oct 2017

    Actual : 01 Oct 2017

  • End Dates

    Planned : 01 Jun 2018

    Actual : 01 Jun 2018

Other Details

  • Design double-blind; parallel; prospective; randomised
  • Phase of Trial Phase I
  • Location Puerto Rico
  • Focus Adverse reactions

Interventions

Drugs Route Formulation
GLS 5700Primary Drug Intradermal
-

GLS-5700

GLS 5700 at 2 mg DNA/dose. GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus
Biological: GLS-5700 (GLS 5700 at 2 mg DNA/dose)

Placebo

Placebo at 0 mg DNA/dose
Biological: Placebo

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Celine Remigio, DPT, RN
215-703-5843 cremigio@geneonels-us.com
show details
-
Ileana Boneta
787-767-9192
show details
University of Puerto Rico Puerto-Rico
Joel Maslow, MD
215-703-5843 jmaslow@geneonels-us.com
show details
-
Michelle Echeandia
787-722-1248
show details
Fundacion De Investigation Puerto-Rico
Monica Rodriguez
787-592-7018
show details
Clinical Research of Puerto Rico Puerto-Rico

Centres

Centre Name Location Trial Centre Country
-
-
-
Clinical Research of Puerto Rico Guyama Puerto-Rico
Fundacion De Investigation San Juan Puerto-Rico
GeneOne Life Science, Inc.
-
-
Inovio Pharmaceuticals
-
-
University of Puerto Rico San Juan Puerto-Rico

Trial History

Event Date Event Type Comment
12 Dec 2018 Other trial event Last checked against Clinicaltrials.gov record. Updated 12 Dec 2018
04 Dec 2018 Status change - completed Status changed from active, no longer recruiting to completed. Updated 12 Dec 2018
13 Jun 2017 Completion date Planned End Date changed from 1 May 2018 to 1 Jun 2018. Updated 19 Jun 2017
13 Jun 2017 Other trial event Planned primary completion date changed from 1 Jun 2017 to 1 Oct 2017. Updated 19 Jun 2017
13 Jun 2017 Status change - active, no longer recruiting Status changed from recruiting to active, no longer recruiting. Updated 19 Jun 2017
10 May 2017 Other trial event According to an Inovio Pharmaceuticals media release, enrollment in this trial is expected to complete by 2Q 2017. Updated 18 May 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 Other trial event According to an Inovio Pharmaceuticals media release, results from this study is expected next year. Updated 27 Dec 2016
26 Sep 2016 Other trial event New source identified and integrated (ClinicalTrials.gov NCT02887482). Updated 26 Sep 2016
19 Sep 2016 New trial record New trial record Updated 19 Sep 2016

References

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

    Available from: URL: http://clinicaltrials.gov
  2. 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
  3. Inovio Pharmaceuticals. Inovios Zika VaccineGenerates Robust Immune Responses in First Human Study. Media-Rel 2016;.

    Media Release
  4. Inovio Pharmaceuticals. Inovio Pharmaceuticals Reports 2017 First Quarter Financial Results. Media-Rel 2017;.

    Media Release
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