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

NCT05216510 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-11-06

Study results available
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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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Premier Research Group plc

    collaborator UNKNOWN

  • Tonix Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Herb Harris, MD · Tonix Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-07
Primary Completion
2022-09-17
Completion
2022-09-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05216510 on ClinicalTrials.gov