A Phase 1 interventional study of TNX-2110 and TNX-2120 in Detection of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 in Individuals Exposed to SARS-CoV-2, sponsored by Tonix Pharmaceuticals, Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-06.
Sponsored by Tonix Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment
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".
1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.
This study's enrollment of 9 is below the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →Tonix Pharmaceuticals, Inc. is the lead sponsor of 34 studies on the registry; 1 is open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 12 (71%) have results posted.
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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.
Healthy uninfected/unexposed subjects to SARS-CoV-2
Biological: TNX-2110 · Biological: TNX-2120 · Biological: TNX-2130 · Biological: CANDIN · Biological: Diluent
Subjects who have recovered from SARS-CoV-2 infection
Biological: TNX-2110 · Biological: TNX-2120 · Biological: TNX-2130 · Biological: CANDIN · Biological: Diluent
Subjects who have received a complete SARS-CoV-2 vaccine course
Biological: TNX-2110 · Biological: TNX-2120 · Biological: TNX-2130 · Biological: CANDIN · Biological: Diluent
TNX-2110 represents epitopes of multiple proteins from SARS-CoV-2 and is administered intradermally.
TNX-2120 represents the spike protein and is administered intradermally.
TNX-2130 represents non-spike proteins and is administered intradermally.
Candida albicans antigens to be administered intradermally as a positive control.
Diluent consists of phosphate buffer, polysorbate 20 and mannitol and will be administered intradermally as a negative control.
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
| Milestone | Cohort 1 | Cohort 2 | Cohort 3 |
|---|---|---|---|
| Started | 1 | 1 | 7 |
| Completed | 0 | 1 | 7 |
| Not completed | 1 | 0 | 0 |
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.
| mm | Cohort 1 | Cohort 2 | Cohort 3 |
|---|---|---|---|
| Assessment of Delayed-type Hypersensitivity Reactions | NA ± NA | NA ± NA | NA ± NA |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1 | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Cohort 2 | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Cohort 3 | 0/7 (0%) | 0/7 (0%) | 7/7 (100%) |
| Event | Cohort 1 | Cohort 2 | Cohort 3 |
|---|---|---|---|
| ErythemaSkin and subcutaneous tissue disorders | 0/1 | 1/1 | 7/7 |
| SwellingGeneral disorders | 1/1 | 1/1 | 3/7 |
| PruritusSkin and subcutaneous tissue disorders | 0/1 | 0/1 | 4/7 |
| PresyncopeNervous system disorders | 0/1 | 0/1 | 1/7 |
| Age, Continuous(years) | Cohort 1 | Cohort 2 | Cohort 3 | Total |
|---|---|---|---|---|
| Mean | 24 | 21 | 31.3 ± 17.45 | 29.3 ± 15.62 |
| Sex: Female, Male(Participants) | Cohort 1 | Cohort 2 | Cohort 3 | Total |
|---|---|---|---|---|
| Female | 1 | 1 | 3 | 5 |
| Male | 0 | 0 | 4 | 4 |
| Race (NIH/OMB)(Participants) | Cohort 1 | Cohort 2 | Cohort 3 | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 | 2 |
| White | 0 | 1 | 6 | 7 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
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Tonix Pharmaceuticals, Inc.