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

NCT ID: NCT05216510

Last Updated: 2024-11-06

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-07

Study Completion Date

2022-09-17

Brief Summary

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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.

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Detailed Description

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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".

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

Healthy uninfected/unexposed subjects to SARS-CoV-2

Group Type EXPERIMENTAL

TNX-2110

Intervention Type BIOLOGICAL

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

TNX-2120

Intervention Type BIOLOGICAL

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

TNX-2130

Intervention Type BIOLOGICAL

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

CANDIN

Intervention Type BIOLOGICAL

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

Diluent

Intervention Type BIOLOGICAL

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

Cohort 2

Subjects who have recovered from SARS-CoV-2 infection

Group Type ACTIVE_COMPARATOR

TNX-2110

Intervention Type BIOLOGICAL

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

TNX-2120

Intervention Type BIOLOGICAL

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

TNX-2130

Intervention Type BIOLOGICAL

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

CANDIN

Intervention Type BIOLOGICAL

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

Diluent

Intervention Type BIOLOGICAL

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

Cohort 3

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

Group Type SHAM_COMPARATOR

TNX-2110

Intervention Type BIOLOGICAL

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

TNX-2120

Intervention Type BIOLOGICAL

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

TNX-2130

Intervention Type BIOLOGICAL

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

CANDIN

Intervention Type BIOLOGICAL

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

Diluent

Intervention Type BIOLOGICAL

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

Interventions

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TNX-2110

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

Intervention Type BIOLOGICAL

TNX-2120

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

Intervention Type BIOLOGICAL

TNX-2130

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

Intervention Type BIOLOGICAL

CANDIN

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

Intervention Type BIOLOGICAL

Diluent

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Premier Research Group plc

UNKNOWN

Sponsor Role collaborator

Tonix Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Herb Harris, MD

Role: STUDY_DIRECTOR

Tonix Pharmaceuticals

Locations

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Clinical Site

Berlin, New Jersey, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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TNX-CA-C201

Identifier Type: -

Identifier Source: org_study_id

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