NCT05085639Unknown1 期
Phase I Study of the Safety, Tolerability and Immunogenicity of GLS-5310 DNA Vaccine Against SARS-CoV-2
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Geometric mean titer (GMT) of antigen specific antibody titers
研究概览
简要总结
Phase I study of the safety, tolerability and immunogenicity of GLS-5310 DNA vaccine against SARS-CoV-2 (COVID-19)
详细描述
This Phase I, randomized, placebo-controlled, dose-ranging, single-blind study will assess the safety, tolerability, and immunogenicity of GLS-5310 DNA vaccine administered intradermally (ID) with or without concomitant intranasal (IN) administration of GLS-5310. Vaccine delivered ID will either be performed by Mantoux injection and followed by suction applied to the skin surface using the Gene-Derm device or Mantous injection alone without applied suction. Vaccine delivered IN will be administered using the MAD300 atomizer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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 to 65 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 during the study
- •Negative test result for the presence of SARS-CoV-2 IgM and IgG antibodies, which indicate recent or prior infection
排除标准
- •Persons involved in the care of patients with COVID-19 and health care workers considered, in the opinion of the investigator, to be at increased risk of infection from SARS-CoV-2
- •Persons with symptoms in the past 2 weeks consistent with possible acute SARS-CoV-2 infection to include fever, loss of smell or taste
- •Persons diagnosis of type 2 diabetes mellitus
- •Persons with a diagnosis of chronic kidney disease
- •Persons with a diagnosis of chronic obstructive pulmonary disease (COPD)
- •Persons with a diagnosis of heart conditions to include heart failure, coronary artery disease, prior heart attack, cardiomyopathy
- •Obesity (BMI of 30 kg/m2 or greater)
- •Sickle cell disease
- •Current or former smoker
- •Current or planned pregnancy during the study
- •Currently breastfeeding
- •Current or past participation in a coronavirus (MERS-CoV, SARS-CoV-2) vaccine study, or receipt of a SARS-CoV-2 vaccine that has been approved by the FDA, including vaccines that have received Emergency Use Authorization (EUA)
- •Administration of an investigational agent within 90 days of the 1st dose
- •Administration of a vaccine within 2 weeks prior to the 1st dose
- •Administration of immune globulin within 6 months of enrollment
- •Administration of an anti-TNFα inhibitor such as infliximab, adalimumab, etanercept, or anti-CD20 monoclonal antibody rituximab within 6 months from enrollment
- •Current daily treatment of systemic corticosteroids of 20 mg of prednisone or greater; or the equivalent dose of other systemic corticosteroids
- •Treatment within the four weeks prior to enrollment with any drug intended for the prophylaxis or treatment of COVID-19
- •Any prior treatment with an anti-SARS-CoV-2 monoclonal antibody or immune serum
- •Prior treatment with an anti-IL-6 inhibitor, anti-IL-1 inhibitor, anti-TNF monoclonal antibody, or anti-JAK inhibitor (see Appendix B exclusionary period for specific drugs)
- •History of malignancy
- •History of transplantation (any organ or bone marrow)
- •Current or planned chemotherapy treatment for hematologic or solid tumor during study period
- •History of other congenital or acquired immunodeficiency, excluding those with HIV infection who are taking highly active antiretroviral therapy and who have documentation of undetectable serum viral load
- •History of PCR-confirmed infection with SARS-CoV-2
- •Not willing to allow storage and future use of samples for SARS-CoV-2 related research and who have a CD4 count > 200 cells/µL on two measures at least 3 months apart
- •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
- •Exclusion criteria (ID + IN only):
- •History of chronic rhinosinusitis
- •History of nasal septal defect or deviated nasal septum
- •History of cleft palate
- •History of nasal polyps
- •History of other disorders that, in the opinion of the investigator, may adversely affect administration of intranasal vaccine
研究组 & 干预措施
GLS-5310 1.2 mg (Group 1)
Experimental
GLS-5310 1.2 mg (ID + Gene-Derm) at Day 0 and Week 8
干预措施: GLS-5130 (Biological)
GLS-5310 2.4 mg (Group 2)
Experimental
GLS-5310 1.2 mg (ID + Gene-Derm) + 1.2 mg (IN) at Day 0 and Week 8
干预措施: GLS-5130 (Biological)
GLS-5310 1.2 mg (Group 3)
Experimental
GLS-5310 1.2 mg ID at Day 0 and Week 8
干预措施: GLS-5130 (Biological)
Placebo (Group 4)
Placebo Comparator
Placebo (ID + Gene-Derm) at Day 0 and Week 8
干预措施: Placebo (Biological)
结局指标
主要结局
Geometric mean titer (GMT) of antigen specific antibody titers
时间窗: Through 56 weeks post vaccination
Endpoint titer of binding antibody in serum
Incidence of adverse events
时间窗: Through 56 weeks post vaccination
solicited/unsolicited local and systemic AEs
次要结局
- Evaluation of positive response rate of T cell responses induced by GLS-5310(Through 56 weeks post vaccination)
- Geometric mean titer (GMT) of neutralizing antibody titers(Through 56 weeks post vaccination)
研究者
研究点 (2)
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