Not provided
Not provided
Not provided
Not provided
Lack of efficacy
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Premier Research | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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".
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Healthy uninfected/unexposed subjects to SARS-CoV-2 |
|
| Cohort 2 | Active Comparator | Subjects who have recovered from SARS-CoV-2 infection |
|
| Cohort 3 | Sham Comparator | Subjects who have received a complete SARS-CoV-2 vaccine course |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TNX-2110 | Biological | TNX-2110 represents epitopes of multiple proteins from SARS-CoV-2 and is administered intradermally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Delayed-type Hypersensitivity Reactions | 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. | Up to 96 hours post skin test administration |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Herb Harris, MD | Tonix Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site | Berlin | New Jersey | 08009 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Based on medical history, patients were assigned into 1 of the 3 groups: Cohort 1 included healthy uninfected/unexposed subject; Cohort 2 included subjects who recovered from SARS-CoV-2 infection at least 2 months prior to enrollment into the study independent of vaccination status; Cohort 3 included subjects who received a complete SARS-CoV-2 vaccine course at least 4 weeks prior to enrollment into the study with no known history of natural infection.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Healthy uninfected/unexposed subjects to SARS-CoV-2 |
| FG001 | Cohort 2 | Subjects who have recovered from SARS-CoV-2 infection |
| FG002 | Cohort 3 | Subjects who have received a complete SARS-CoV-2 vaccine course |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Healthy uninfected/unexposed subjects to SARS-CoV-2 |
| BG001 | Cohort 2 | Subjects who have recovered from SARS-CoV-2 infection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Assessment of Delayed-type Hypersensitivity Reactions | 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. | mITT Population includes all randomized subjects who completed Stages 1 and 2 of administration and had induration responses for at least one post skin test administration visit at hour 48, 72, or 96. | Posted | Mean | Standard Deviation | mm | Up to 96 hours post skin test administration |
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | uninfected/unexposed healthy individuals | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Herb Harris, MD, PhD | Tonix Pharmaceuticals | (862) 904-0355 | herb.harris@tonixpharma.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 7, 2021 | Jan 23, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 27, 2022 | Jan 23, 2024 | SAP_001.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| TNX-2120 | Biological | TNX-2120 represents the spike protein and is administered intradermally. |
|
| TNX-2130 | Biological | TNX-2130 represents non-spike proteins and is administered intradermally. |
|
| CANDIN | Biological | Candida albicans antigens to be administered intradermally as a positive control. |
|
| Diluent | Biological | Diluent consists of phosphate buffer, polysorbate 20 and mannitol and will be administered intradermally as a negative control. |
|
| BG002 | Cohort 3 | Subjects who have received a complete SARS-CoV-2 vaccine course |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Subjects who have recovered from SARS-CoV-2 infection |
| OG002 | Cohort 3 | Subjects who have received a complete SARS-CoV-2 vaccine course |
|
|
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | Cohort 2 | individuals confirmed to have recovered from SARS-CoV-2 infection independent of vaccination status | 0 | 1 | 0 | 1 | 1 | 1 |
| EG002 | Cohort 3 | individuals who had received a complete SARS-CoV-2 vaccine course with no known history of natural infection | 0 | 7 | 0 | 7 | 7 | 7 |
| Swelling | General disorders | MedDRA 24.0 | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 24.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
|
An industry standard NDA is in place with all study investigators.