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

November 1, 2024 updated by: Tonix Pharmaceuticals, Inc.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Healthy uninfected/unexposed subjects to SARS-CoV-2
Biological: TNX-2110
TNX-2110 represents epitopes of multiple proteins from SARS-CoV-2 and is administered intradermally.
Biological: TNX-2120
TNX-2120 represents the spike protein and is administered intradermally.
Biological: TNX-2130
TNX-2130 represents non-spike proteins and is administered intradermally.
Biological: CANDIN
Candida albicans antigens to be administered intradermally as a positive control.
Biological: Diluent
Diluent consists of phosphate buffer, polysorbate 20 and mannitol and will be administered intradermally as a negative control.
Active Comparator: Cohort 2
Subjects who have recovered from SARS-CoV-2 infection
Biological: TNX-2110
TNX-2110 represents epitopes of multiple proteins from SARS-CoV-2 and is administered intradermally.
Biological: TNX-2120
TNX-2120 represents the spike protein and is administered intradermally.
Biological: TNX-2130
TNX-2130 represents non-spike proteins and is administered intradermally.
Biological: CANDIN
Candida albicans antigens to be administered intradermally as a positive control.
Biological: Diluent
Diluent consists of phosphate buffer, polysorbate 20 and mannitol and will be administered intradermally as a negative control.
Sham Comparator: Cohort 3
Subjects who have received a complete SARS-CoV-2 vaccine course
Biological: TNX-2110
TNX-2110 represents epitopes of multiple proteins from SARS-CoV-2 and is administered intradermally.
Biological: TNX-2120
TNX-2120 represents the spike protein and is administered intradermally.
Biological: TNX-2130
TNX-2130 represents non-spike proteins and is administered intradermally.
Biological: CANDIN
Candida albicans antigens to be administered intradermally as a positive control.
Biological: Diluent
Diluent consists of phosphate buffer, polysorbate 20 and mannitol and will be administered intradermally as a negative control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 96 hours post skin test administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tonix Pharmaceuticals, Inc.

Collaborators

Premier Research Group plc

Investigators

  • Study Director: Herb Harris, MD, Tonix Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2022

Primary Completion (Actual)

September 17, 2022

Study Completion (Actual)

September 17, 2022

Study Registration Dates

First Submitted

January 28, 2022

First Submitted That Met QC Criteria

January 28, 2022

First Posted (Actual)

January 31, 2022

Study Record Updates

Last Update Posted (Actual)

November 6, 2024

Last Update Submitted That Met QC Criteria

November 1, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNX-CA-C201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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