Phase I, Open-label, Dose Ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of GLS-5300, Administered IM Followed by Electroporation in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Mean change from baseline in safety laboratory measures
研究概览
简要总结
The Middle East Respiratory Syndrome Coronavirus (MERS CoV), a virus related to Severe Acute respiratory syndrome coronavirus (SARS CoV), was first recognized as a cause of severe pulmonary infection in 2012. Infection with MERS CoV has been diagnosed in more than 1600 individuals with a mortality rate between 35% and 40%. GLS-5300 is a DNA plasmid vaccine that expresses the MERS CoV spike (S) glycoprotein. This study will evaluate the safety of GLS-5300 at one of three dose levels following a three-injection vaccination regimen followed by electroporation. The study will also assess immune responses over a 1 year period with respect to the generation of antibody and cellular responses.
详细描述
GLS-5300 is a DNA plasmid vaccine that expresses the MERS CoV spike (S) glycoprotein. Following administration of the vaccine, a specialized medical device, CELLECTRA®, will deliver brief electrical pulses in a process known as electroporation (EP), to help move DNA into cells more efficiently.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-50 years; military, civilian, male and female.
- •Able to provide consent to participate and having signed an Informed Consent Form.
- •Able and willing to comply with all study procedures.
- •Women of child-bearing potential agree to remain sexually abstinent, 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 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 unable to become pregnant;
- •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;
- •No history of clinically significant immunosuppressive or autoimmune disease.
- •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).
- •Willing to allow storage and future use of samples for MERS CoV related research
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 MERS CoV except if participant is verified to have received placebo;
- •Previous infection with MERS CoV as assessed by self report and solicited exposure history;
- •Administration of any vaccine within 4 weeks of first dose;
- •A BMI greater than or equal to 35;
- •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;
- •History of 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 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
- •Tattoos covering the injection site area h
- •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-5300 at 6 mg DNA/dose
GLS-5300 at 6 mg DNA/dose
干预措施: GLS-5300 (Biological)
GLS-5300 at 2 mg DNA/dose
GLS-5300 at 2 mg DNA/dose
干预措施: GLS-5300 (Biological)
GLS-5300
GLS-5300 at 0.67 mg DNA/dose
干预措施: GLS-5300 (Biological)
结局指标
主要结局
Mean change from baseline in safety laboratory measures
时间窗: Day0 through Week 60
Incidence of unsolicited adverse events after vaccination
时间窗: Day0 through Week 60
Incidence of serious adverse events
时间窗: Day0 through Week 60
Incidence of solicited adverse events after vaccination
时间窗: Day0 through Week 60
次要结局
- T cell response(Day 0 through Week 60 following the first dose)
- Neutralizing antibody response to S protein(Day0 through Week 60 following the first dose)
- Binding antibody response to S protein(Day0 through Week 60 following the first dose)