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

Phase 1TerminatedNCT05216510

Tonix Pharmaceuticals, Inc.9 enrolled

Overview

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".

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Clinical Site

Berlin, New Jersey, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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