NCT05216510

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2022

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2022

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 31, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2022

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

November 6, 2024

Completed
Last Updated

November 6, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

January 28, 2022

Results QC Date

January 23, 2024

Last Update Submit

November 1, 2024

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • Assessment of Delayed-type Hypersensitivity Reactions

    The primary efficacy endpoint of this study is the maximal area of induration ≥5 mm at injection sites on the volar aspect of the forearms of 3 time points post skin test administration. The outcome measure is the maximum of the area of induration of 48 hours, 72 hours, and 96 hours.

    Up to 96 hours post skin test administration

Study Arms (3)

Cohort 1

EXPERIMENTAL

Healthy uninfected/unexposed subjects to SARS-CoV-2

Biological: TNX-2110Biological: TNX-2120Biological: TNX-2130Biological: CANDINBiological: Diluent

Cohort 2

ACTIVE COMPARATOR

Subjects who have recovered from SARS-CoV-2 infection

Biological: TNX-2110Biological: TNX-2120Biological: TNX-2130Biological: CANDINBiological: Diluent

Cohort 3

SHAM COMPARATOR

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

Biological: TNX-2110Biological: TNX-2120Biological: TNX-2130Biological: CANDINBiological: Diluent

Interventions

TNX-2110BIOLOGICAL

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

Cohort 1Cohort 2Cohort 3
TNX-2120BIOLOGICAL

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

Cohort 1Cohort 2Cohort 3
TNX-2130BIOLOGICAL

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

Cohort 1Cohort 2Cohort 3
CANDINBIOLOGICAL

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

Cohort 1Cohort 2Cohort 3
DiluentBIOLOGICAL

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

Cohort 1Cohort 2Cohort 3

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Site

Berlin, New Jersey, 08009, United States

Location

Results Point of Contact

Title
Herb Harris, MD, PhD
Organization
Tonix Pharmaceuticals
herb.harris@tonixpharma.com
(862) 904-0355

Study Officials

  • Herb Harris, MD

    Tonix Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2022

First Posted

January 31, 2022

Study Start

January 7, 2022

Primary Completion

September 17, 2022

Study Completion

September 17, 2022

Last Updated

November 6, 2024

Results First Posted

November 6, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)