Assessment of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 Peptide Antigens
- Conditions
- Detection of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 in Individuals Exposed to SARS-CoV-2
- Interventions
- Registration Number
- NCT05216510
- Lead Sponsor
- Tonix Pharmaceuticals, Inc.
- Brief Summary
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.
- Detailed Description
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".
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort 1 Diluent Healthy uninfected/unexposed subjects to SARS-CoV-2 Cohort 3 TNX-2130 Subjects who have received a complete SARS-CoV-2 vaccine course Cohort 2 TNX-2130 Subjects who have recovered from SARS-CoV-2 infection Cohort 2 TNX-2120 Subjects who have recovered from SARS-CoV-2 infection Cohort 3 TNX-2110 Subjects who have received a complete SARS-CoV-2 vaccine course Cohort 3 CANDIN Subjects who have received a complete SARS-CoV-2 vaccine course Cohort 1 TNX-2130 Healthy uninfected/unexposed subjects to SARS-CoV-2 Cohort 1 CANDIN Healthy uninfected/unexposed subjects to SARS-CoV-2 Cohort 2 TNX-2110 Subjects who have recovered from SARS-CoV-2 infection Cohort 3 Diluent Subjects who have received a complete SARS-CoV-2 vaccine course Cohort 2 CANDIN Subjects who have recovered from SARS-CoV-2 infection Cohort 2 Diluent Subjects who have recovered from SARS-CoV-2 infection Cohort 3 TNX-2120 Subjects who have received a complete SARS-CoV-2 vaccine course Cohort 1 TNX-2110 Healthy uninfected/unexposed subjects to SARS-CoV-2 Cohort 1 TNX-2120 Healthy uninfected/unexposed subjects to SARS-CoV-2
- Primary Outcome Measures
Name Time Method Assessment of Delayed-type Hypersensitivity Reactions 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Site
🇺🇸Berlin, New Jersey, United States