Detection of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 in Individuals Exposed to SARS-CoV-2
Conditions
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.
Interventions
BIOLOGICALDiluent
Diluent consists of phosphate buffer, polysorbate 20 and mannitol and will be administered intradermally as a negative control.
BIOLOGICALTNX-2110
TNX-2110 represents epitopes of multiple proteins from SARS-CoV-2 and is administered intradermally.
BIOLOGICALTNX-2120
TNX-2120 represents the spike protein and is administered intradermally.
BIOLOGICALTNX-2130
TNX-2130 represents non-spike proteins and is administered intradermally.
BIOLOGICALCANDIN
Candida albicans antigens to be administered intradermally as a positive control.
Sponsors
Premier Research
Tonix Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 Healthy uninfected/unexposed subjects to SARS-CoV-2 | 1 |
| Cohort 2 Subjects who have recovered from SARS-CoV-2 infection | 1 |
| Cohort 3 Subjects who have received a complete SARS-CoV-2 vaccine course | 7 |
| Total | 9 |
Baseline characteristics
| Characteristic | Cohort 1 | Cohort 2 | Cohort 3 | Total |
|---|---|---|---|---|
| Age, Continuous | 24 years | 21 years | 31.3 years STANDARD_DEVIATION 17.45 | 29.3 years STANDARD_DEVIATION 15.62 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 1 Participants | 6 Participants | 7 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 4 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 | 0 / 7 |
| other Total, other adverse events | 1 / 1 | 1 / 1 | 7 / 7 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 | 0 / 7 |
Outcome results
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.
Time frame: Up to 96 hours post skin test administration
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cohort 1 | Assessment of Delayed-type Hypersensitivity Reactions | NA mm |
| Cohort 2 | Assessment of Delayed-type Hypersensitivity Reactions | NA mm |
| Cohort 3 | Assessment of Delayed-type Hypersensitivity Reactions | NA mm |