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

Purpose

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.

Condition

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

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

More Details

NCT ID
NCT05216510
Status
Unknown status
Sponsor
Tonix Pharmaceuticals, Inc.