Phase 1
N=40
GLS-5700 in Dengue Virus-Naïve Adults
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02809443 ↗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
| Outcome | Result | p-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
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.