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Phase 1 N=40 Prevention

GLS-5700 in Dengue Virus-Naïve Adults

Healthy

Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Number of Participants With Serious Adverse Events From Day 0 Through Week 60 — 0; 0 participants

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
GLS-5700 (Biological)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
GeneOne Life Science, Inc.
Primary completion
Nov 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Serious Adverse Events From Day 0 Through Week 60
0; 0
SECONDARY
Binding Antibody Response to Zika Envelope
20; 19
SECONDARY
T Cell Response
35; 154

Summary

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.

Eligibility Criteria

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 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).

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 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
  • No
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02809443). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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