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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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.