Assessment of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 Peptide Antigens

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Detection of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 in Individuals Exposed to SARS-CoV-2

Intervention / Treatment
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* Biological: TNX-2110
* Biological: TNX-2120
* Biological: TNX-2130
* Biological: CANDIN
* Biological: Diluent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Healthy uninfected/unexposed subjects to SARS-CoV-2 | Biological: TNX-2110<br>* TNX-2110 represents epitopes of multiple proteins from SARS-CoV-2 and is administered intradermally.<br>Biological: TNX-2120<br>* TNX-2120 represents the spike protein and is administered intradermally.<br>Biological: TNX-2130<br>* TNX-2130 represents non-spike proteins and is administered intradermally.<br>Biological: CANDIN<br>* Candida albicans antigens to be administered intradermally as a positive control.<br>Biological: Diluent<br>* Diluent consists of phosphate buffer, polysorbate 20 and mannitol and will be administered intradermally as a negative control.<br>|
| Active Comparator: Cohort 2<br>Subjects who have recovered from SARS-CoV-2 infection | Biological: TNX-2110<br>* TNX-2110 represents epitopes of multiple proteins from SARS-CoV-2 and is administered intradermally.<br>Biological: TNX-2120<br>* TNX-2120 represents the spike protein and is administered intradermally.<br>Biological: TNX-2130<br>* TNX-2130 represents non-spike proteins and is administered intradermally.<br>Biological: CANDIN<br>* Candida albicans antigens to be administered intradermally as a positive control.<br>Biological: Diluent<br>* Diluent consists of phosphate buffer, polysorbate 20 and mannitol and will be administered intradermally as a negative control.<br>|
| Sham Comparator: Cohort 3<br>Subjects who have received a complete SARS-CoV-2 vaccine course | Biological: TNX-2110<br>* TNX-2110 represents epitopes of multiple proteins from SARS-CoV-2 and is administered intradermally.<br>Biological: TNX-2120<br>* TNX-2120 represents the spike protein and is administered intradermally.<br>Biological: TNX-2130<br>* TNX-2130 represents non-spike proteins and is administered intradermally.<br>Biological: CANDIN<br>* Candida albicans antigens to be administered intradermally as a positive control.<br>Biological: Diluent<br>* Diluent consists of phosphate buffer, polysorbate 20 and mannitol and will be administered intradermally as a negative control.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 Peptide Antigens | Maximal area of induration ≥5 mm at injection sites on the volar forearms | Up to 96 hours post skin test administration |