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Assessment of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 Peptide Antigens (COVID-19 DTH)

Primary Purpose

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

Status

Active

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

TNX-2110

TNX-2120

TNX-2130

CANDIN

Diluent

About this trial

This is an interventional treatment trial for Detection of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 in Individuals Exposed to SARS-CoV-2

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Clinical Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

Healthy uninfected/unexposed subjects to SARS-CoV-2

Subjects who have recovered from SARS-CoV-2 infection

Subjects who have received a complete SARS-CoV-2 vaccine course

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05216510

First Posted

January 28, 2022

Last Updated

May 3, 2022

Sponsor

Tonix Pharmaceuticals, Inc.

Collaborators

Premier Research Group plc

1. Study Identification

Unique Protocol Identification Number

NCT05216510

Brief Title

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

Acronym

COVID-19 DTH

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 7, 2022 (Actual)

Primary Completion Date

June 2022 (Anticipated)

Study Completion Date

August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tonix Pharmaceuticals, Inc.

Collaborators

Premier Research Group plc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm Description

Healthy uninfected/unexposed subjects to SARS-CoV-2

Arm Title

Cohort 2

Arm Type

Active Comparator

Arm Description

Subjects who have recovered from SARS-CoV-2 infection

Arm Title

Cohort 3

Arm Type

Sham Comparator

Arm Description

Subjects who have received a complete SARS-CoV-2 vaccine course

Intervention Type

Biological

Intervention Name(s)

TNX-2110

Intervention Description

TNX-2110 represents epitopes of multiple proteins from SARS-CoV-2 and is administered intradermally.

Intervention Type

Biological

Intervention Name(s)

TNX-2120

Intervention Description

TNX-2120 represents the spike protein and is administered intradermally.

Intervention Type

Biological

Intervention Name(s)

TNX-2130

Intervention Description

TNX-2130 represents non-spike proteins and is administered intradermally.

Intervention Type

Biological

Intervention Name(s)

CANDIN

Intervention Description

Candida albicans antigens to be administered intradermally as a positive control.

Intervention Type

Biological

Intervention Name(s)

Diluent

Intervention Description

Diluent consists of phosphate buffer, polysorbate 20 and mannitol and will be administered intradermally as a negative control.

Primary Outcome Measure Information:

Title

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

Description

Maximal area of induration ≥5 mm at injection sites on the volar forearms

Time Frame

Up to 96 hours post skin test administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Herb Harris, MD

Organizational Affiliation

Tonix Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Clinical Site

City

Berlin

State/Province

New Jersey

ZIP/Postal Code

08009

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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