NCT05216510

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Tonix Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

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".

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-01-07
• Primary completion: 2022-09-17
• Completion: 2022-09-17
• First posted: 2022-01-31
• Last updated: 2024-11-06
• Results posted: 2024-11-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study