Detection of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 in Individuals Exposed to SARS-CoV-2Phase 1COVID-19 DTHNCT05216510
Assessment of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 Peptide Antigens
A Phase 1 study testing TNX-2110, TNX-2120 and TNX-2130 in people with Detection of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 in Individuals Exposed to SARS-CoV-2, run by Tonix Pharmaceuticals, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Detection of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 in Individuals Exposed to SARS-CoV-2
- What is being tested?
- TNX-2110, TNX-2120 and TNX-2130
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2022to 17 Sep 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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".
- Being tested
- TNX-2110, TNX-2120, TNX-2130, CANDIN, Diluent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNX-2110Biological
TNX-2110 represents epitopes of multiple proteins from SARS-CoV-2 and is administered intradermally.
TNX-2120Biological
TNX-2120 represents the spike protein and is administered intradermally.
TNX-2130Biological
TNX-2130 represents non-spike proteins and is administered intradermally.
CANDINBiological
Candida albicans antigens to be administered intradermally as a positive control.
DiluentBiological
Diluent consists of phosphate buffer, polysorbate 20 and mannitol and will be administered intradermally as a negative control.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Healthy uninfected/unexposed subjects to SARS-CoV-2 Receives: Biological: TNX-2110; Biological: TNX-2120; Biological: TNX-2130; Biological: CANDIN; Biological: Diluent |
| Cohort 2 | Active comparator | Subjects who have recovered from SARS-CoV-2 infection Receives: Biological: TNX-2110; Biological: TNX-2120; Biological: TNX-2130; Biological: CANDIN; Biological: Diluent |
| Cohort 3 | Sham comparator | Subjects who have received a complete SARS-CoV-2 vaccine course Receives: Biological: TNX-2110; Biological: TNX-2120; Biological: TNX-2130; Biological: CANDIN; Biological: Diluent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 96 hours post skin test administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start7 Jan 2022
- Primary completion17 Sep 2022
- Study completion17 Sep 2022
Why it stopped: Lack of efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Detection of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 in Individuals Exposed to SARS-CoV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tonix Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Responsible party
- Sponsor
- Investigators
- Herb Harris, MD, Study director, Tonix Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216510
- Sponsor's protocol ID
- TNX-CA-C201
- Acronym
- COVID-19 DTH
- Status last verified
- Nov 2024
- First submitted
- 28 Jan 2022
- Last updated
- 6 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05216510
- Acronym / sponsor ID
- COVID-19 DTH / TNX-CA-C201
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Tonix Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- 17 Sep 2022 (actual)
- Study completion
- 17 Sep 2022 (actual)
- First posted
- 31 Jan 2022 (actual)
- Results
- Posted 6 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: TNX-2110, Biological: TNX-2120, Biological: TNX-2130, Biological: CANDIN, Biological: DiluentHealthy uninfected/unexposed subjects to SARS-CoV-2 |
| Cohort 2 | Active comparator | Biological: TNX-2110, Biological: TNX-2120, Biological: TNX-2130, Biological: CANDIN, Biological: DiluentSubjects who have recovered from SARS-CoV-2 infection |
| Cohort 3 | Sham comparator | Biological: TNX-2110, Biological: TNX-2120, Biological: TNX-2130, Biological: CANDIN, Biological: DiluentSubjects who have received a complete SARS-CoV-2 vaccine course |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TNX-2110TNX-2110 represents epitopes of multiple proteins from SARS-CoV-2 and is administered intradermally. | Biological | Cohort 1, Cohort 2, Cohort 3 |
| TNX-2120TNX-2120 represents the spike protein and is administered intradermally. | Biological | Cohort 1, Cohort 2, Cohort 3 |
| TNX-2130TNX-2130 represents non-spike proteins and is administered intradermally. | Biological | Cohort 1, Cohort 2, Cohort 3 |
| CANDINCandida albicans antigens to be administered intradermally as a positive control. | Biological | Cohort 1, Cohort 2, Cohort 3 |
| DiluentDiluent consists of phosphate buffer, polysorbate 20 and mannitol and will be administered intradermally as a negative control. | Biological | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Assessment of Delayed-type Hypersensitivity Reactions
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herb Harris, MD study director
Tonix Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TNX-2110, TNX-2120 and TNX-2130 in people with Detection of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 in Individuals Exposed to SARS-CoV-2, run by Tonix Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Delayed-type Hypersensitivity Reactions (time frame: Up to 96 hours post skin test administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.