GLS-5700 in Dengue Virus-Naïve Adults

Completed · Phase 1

Conditions studied: Healthy

In brief

The clinical trial will assess the safety, tolerability, and immunogenicity of GLS-5700. GLS-5700 is a synthetic DNA plasmid vaccine against the Zika virus. ZIKA-001 is the first in man clinical trial of this vaccine which encodes for the premembrane-membrane and envelope regions of Zika virus.

Key facts

Study ID

NCT02809443

Run by

GeneOne Life Science, Inc.

People needed

40

Starts

2016-07-01

Expected to finish

2017-12-01

Last updated by the study team

2024-12-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 is medically unable to become pregnant;
• Normal screening ECG or screening ECG with no clinically significant findings;
• Screening laboratory must be within normal limits or have only Grade 0-1 findings;
• No history of clinically significant immunosuppressive or autoimmune disease.
• No history of dengue virus vaccination or illness; no history of yellow fever vaccination.
• Dengue seronegative at baseline by screening laboratory evaluation
• 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).

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 Zika virus except if participant 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 plans to become pregnant during the course of the study;
• 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;
• 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, except for Grade 2 creatinine;
• 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);
• 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 participants 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 participant or the evaluation of any study endpoint.

Where it is running

• Miami Research Associate — Miami, Florida, United States
• University of Pennslyvania — Philadelphia, Pennsylvania, United States
• CHU de Québec -Université Laval hopital CHUL Centre de Recherche en infectiologie — Québec, Canada

Full record on ClinicalTrials.gov

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