NCT02809443已完成1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Number of Participants With Serious Adverse Events From Day 0 Through Week 60
研究概览
简要总结
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.
详细描述
GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
GLS-5700 at 1 mg
Experimental
DNA/dose
干预措施: GLS-5700 (Biological)
GLS-5700 at 2 mg
Experimental
DNA/dose
干预措施: GLS-5700 (Biological)
结局指标
主要结局
Number of Participants With Serious Adverse Events From Day 0 Through Week 60
时间窗: Day 0 through Week 60
次要结局
- Binding Antibody Response to Zika Envelope(Week 14 (2 weeks after the 3rd dose))
- T Cell Response(Maximum response over follow up period up to 60 weeks.)
研究者
研究点 (3)
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