Multicenter, Randomized, Combined Phase I Dose-escalation and Phase IIa Double-blind, Placebo-controlled Study of the Safety, Tolerability, and Immunogenicity of GLS-5310 DNA Vaccine, Administered Intradermally Against SARS-CoV-2 in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- Number of Serious Adverse Events
研究概览
简要总结
This clinical trial will evaluate the safety, tolerability and immunogenicity of GLS-5310 DNA vaccine against SARS-CoV-2(COVID-19) in healthy volunteers.
详细描述
This Phase I / IIa study will assess the safety, tolerability, and immunogenicity of GLS-5310 DNA vaccine.
The Phase I portion of this study is an open-label, dose escalation study to assess two dose levels of GLS-5310 DNA vaccine (0.6 and 1.2 mg) as part of two vaccination regimens (0-8 weeks and 0-12 weeks).
The Phase IIa portion of this study is designed as a randomized, double-blind, placebo-controlled study with only a single active study drug arm. Subjects will be randomized to receive either placebo or GLS-5310 vaccine in a 1:2 ratio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 19 to 85 years of age (Phase I will be restricted to an upper age limit of 50 years of age)
- •Able to provide informed consent
- •Able and willing to comply with study procedures
- •For women of childbearing potential, able and willing to use an approved form of pregnancy prevention through to 4 weeks post boost vaccination
排除标准
- •Current or planned pregnancy through to 4 weeks post-boost vaccination for women of childbearing potential
- •Currently breastfeeding
- •Current or past participation in a coronavirus (MERS-CoV, SARS-CoV-2) vaccine study
- •Administration of an investigational agent within 6 months of the 1st dose
- •Administration of a vaccine within 4 weeks prior to the 1st dose
- •Administration of immune globulin within 16 weeks of enrollment
- •Administration of an anti-TNFα inhibitor such as infliximab, adalimumab, etanercept, or anti-CD20 monoclonal antibody rituximab within 24 weeks prior to enrollment
- •Current daily treatment of systemic corticosteroids of 20 mg of prednisone or greater, dexamethasone of 3 mg or greater; or the equivalent dose of other systemic corticosteroids
- •Administration of any Immunosuppressive Drug or Immunomodulator within 3 months of the first dose
- •History of bone marrow transplantation
- •Current or planned chemotherapy treatment for hematologic or solid tumor during study period or treatment during the 5 years prior to enrollment
- •Respiratory disease (ex. Asthma, Chronic obstructive lung disease)
- •Cardiovascular disease (ex. myocardial ischemia, congestive heart failure, cardiomyopathy, clinically significant arrhythmia)
- •Hypertension (Systolic pressure >150mmHg or Diastolic pressure >95mmHg)
- •Confirmed Diabetes
- •Severe allergic reaction or anaphylactic reaction after vaccination in the past
- •Immunosuppresion including immunodeficiency disease or family history
- •Positive of serum test at screening (Hepatitis B, Hepatitis A, HIV, Hepatitis C)
- •Baseline screening lab(s) with Non Clinical Significant abnormality
- •Serious adverse reaction to a drug containing Investigational Product (GLS-5310) or other ingredients of the same categories or to a vaccine or antibiotic, nonsteroidal anti-inflammatory disease control, etc. or an allergic history
- •History of hypersensitivity to vaccination such as Guillain-Barre syndrome
- •History of PCR-confirmed infection with SARS-CoV-2 at screening
- •Subjects who have been contact with COVID-19 infections in the past prior to administration, have been classified as COVID-19 confirmed patients, medical patients or patients with symptoms or have been identified with SARS and MERS infection history in the past
- •37.5 degrees, cough, difficulty breathing, chills, muscle aches, headache, sore throat, loss of smell, or loss of taste within 72 hours prior to administration
- •Healthcare workers participating in the medical examination of patients infected with COVID-19
- •Not willing to allow storage and future use of samples for SARS-CoV-2 related research
- •Prisoner or subjects who are compulsorily detained for treatment of a psychiatric illness
- •Any illness or condition that, in the opinion of the investigator, may affect the safety of the subject or the evaluation of a study endpoint
研究组 & 干预措施
GLS-5310 0.6mg [Group 1a]
0.6mg of GLS-5310 will be intradermally administered on Day 0 and Week 8.
干预措施: GLS-5310 (Biological)
GLS-5310 1.2mg [Group 1b]
1.2mg of GLS-5310 will be intradermally administered on Day 0 and Week 8.
干预措施: GLS-5310 (Biological)
GLS-5310 1.2mg [Group 1c]
1.2mg of GLS-5310 will be intradermally administered on Day 0 and Week 12.
干预措施: GLS-5310 (Biological)
Placebo [Group 2a]
Placebo will be intradermally administered on Day 0 and Week 8 (or Week 12).
干预措施: Placebo (Biological)
GLS-5310 1.2mg [Group 2b]
1.2mg of GLS-5310 will be intradermally administered on Day 0 and Week 8 (or Week 12).
干预措施: GLS-5310 (Biological)
结局指标
主要结局
Number of Serious Adverse Events
时间窗: Through 48 weeks post vaccination
次要结局
- Number of Participants With Positive T Cell Responses Induced by GLS-5310(Post vaccination Visit 4 (4 weeks after week 8 or week 12 vaccination))
- Number of Participants With Positive Neutralizing Antibody Responses Induced by GLS-5310(Post vaccination Visit 4 (4 weeks after week 8 or week 12 vaccination))