A Dose Finding Study for the Assessment of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 Peptide Antigens in Uninfected Healthy Subjects, COVID-19 Convalescent Subjects, and COVID-19 Vaccinated Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Assessment of Delayed-type Hypersensitivity Reactions
研究概览
简要总结
This dose finding, multi-cohort study is designed to evaluate the safety and efficacy of intradermally-injectedTNX-2100, synthesized SARS-CoV-2 peptide antigens and assess the presence and magnitude of DTH reactions.
详细描述
Three IPs (TNX-2110, TNX- 2120, TNX-2130) will be administered by intradermal injection (0.1 mL) in two concentration strengths (Stage 1: "1:10 dilution" and Stage 2: "undiluted"). Subjects will also receive one intradermal injection (0.1 mL) of a positive control (CANDIN®), and one intradermal injection (0.1 mL) of a negative control "diluent".
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Male or female subjects aged 18 - 65 years of age, inclusive, in good general health as determined by medical evaluation Subject receives a negativeSARS-CoV-2 PCR test result at their screening or baseline visit
排除标准
- •Subjects will be excluded if they have clinically significant underlying conditions associated with high risk for severe COVID-19 infections as identified by the Centers for Disease Control and Prevention (CDC) (Appendix 2). These conditions include, but are not limited to: chronic obstructive pulmonary disease, diabetes mellitus (Type 1 and 2), obesity, hypertension, heart disease, and cerebrovascular disease.
研究组 & 干预措施
Cohort 1
Healthy uninfected/unexposed subjects to SARS-CoV-2
干预措施: TNX-2110 (Biological)
Cohort 1
Healthy uninfected/unexposed subjects to SARS-CoV-2
干预措施: TNX-2120 (Biological)
Cohort 1
Healthy uninfected/unexposed subjects to SARS-CoV-2
干预措施: TNX-2130 (Biological)
Cohort 1
Healthy uninfected/unexposed subjects to SARS-CoV-2
干预措施: CANDIN (Biological)
Cohort 1
Healthy uninfected/unexposed subjects to SARS-CoV-2
干预措施: Diluent (Biological)
Cohort 2
Subjects who have recovered from SARS-CoV-2 infection
干预措施: TNX-2110 (Biological)
Cohort 2
Subjects who have recovered from SARS-CoV-2 infection
干预措施: TNX-2120 (Biological)
Cohort 2
Subjects who have recovered from SARS-CoV-2 infection
干预措施: TNX-2130 (Biological)
Cohort 2
Subjects who have recovered from SARS-CoV-2 infection
干预措施: CANDIN (Biological)
Cohort 2
Subjects who have recovered from SARS-CoV-2 infection
干预措施: Diluent (Biological)
Cohort 3
Subjects who have received a complete SARS-CoV-2 vaccine course
干预措施: TNX-2110 (Biological)
Cohort 3
Subjects who have received a complete SARS-CoV-2 vaccine course
干预措施: TNX-2120 (Biological)
Cohort 3
Subjects who have received a complete SARS-CoV-2 vaccine course
干预措施: TNX-2130 (Biological)
Cohort 3
Subjects who have received a complete SARS-CoV-2 vaccine course
干预措施: CANDIN (Biological)
Cohort 3
Subjects who have received a complete SARS-CoV-2 vaccine course
干预措施: Diluent (Biological)
结局指标
主要结局
Assessment of Delayed-type Hypersensitivity Reactions
时间窗: Up to 96 hours post skin test administration
The primary efficacy endpoint of this study is the maximal area of induration ≥5 mm at injection sites on the volar aspect of the forearms of 3 time points post skin test administration. The outcome measure is the maximum of the area of induration of 48 hours, 72 hours, and 96 hours.
次要结局
未报告次要终点