Trial Outcomes & Findings for Assessment of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 Peptide Antigens (NCT NCT05216510)

Last Updated: 2024-11-06

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

9 participants

Primary outcome timeframe

Up to 96 hours post skin test administration

Results posted on

2024-11-06

Participant Flow

Based on medical history, patients were assigned into 1 of the 3 groups: Cohort 1 included healthy uninfected/unexposed subject; Cohort 2 included subjects who recovered from SARS-CoV-2 infection at least 2 months prior to enrollment into the study independent of vaccination status; Cohort 3 included subjects who received a complete SARS-CoV-2 vaccine course at least 4 weeks prior to enrollment into the study with no known history of natural infection.

Participant milestones

Participant milestones
Measure	Cohort 1 Healthy uninfected/unexposed subjects to SARS-CoV-2	Cohort 2 Subjects who have recovered from SARS-CoV-2 infection	Cohort 3 Subjects who have received a complete SARS-CoV-2 vaccine course
Overall Study STARTED	1	1	7
Overall Study COMPLETED	0	1	7
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 n=1 Participants Healthy uninfected/unexposed subjects to SARS-CoV-2	Cohort 2 n=1 Participants Subjects who have recovered from SARS-CoV-2 infection	Cohort 3 n=7 Participants Subjects who have received a complete SARS-CoV-2 vaccine course	Total n=9 Participants Total of all reporting groups
Age, Continuous	24 years n=5 Participants	21 years n=7 Participants	31.3 years STANDARD_DEVIATION 17.45 • n=5 Participants	29.3 years STANDARD_DEVIATION 15.62 • n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 96 hours post skin test administration

Population: mITT Population includes all randomized subjects who completed Stages 1 and 2 of administration and had induration responses for at least one post skin test administration visit at hour 48, 72, or 96.

Outcome measures

Outcome measures
Measure	Cohort 1 n=1 Participants Healthy uninfected/unexposed subjects to SARS-CoV-2	Cohort 2 n=1 Participants Subjects who have recovered from SARS-CoV-2 infection	Cohort 3 n=6 Participants Subjects who have received a complete SARS-CoV-2 vaccine course
Assessment of Delayed-type Hypersensitivity Reactions	NA mm Standard Deviation NA Induration (Delayed-type Hypersensitivity Reactions to SARS-CoV-2 Peptide Antigens reaction) was not observed and could not be measured.	NA mm Standard Deviation NA Induration (Delayed-type Hypersensitivity Reactions to SARS-CoV-2 Peptide Antigens reaction) was not observed and could not be measured.	NA mm Standard Deviation NA Induration (Delayed-type Hypersensitivity Reactions to SARS-CoV-2 Peptide Antigens reaction) was not observed and could not be measured.

Adverse Events

Cohort 1

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort 2

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort 3

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cohort 1 n=1 participants at risk uninfected/unexposed healthy individuals	Cohort 2 n=1 participants at risk individuals confirmed to have recovered from SARS-CoV-2 infection independent of vaccination status	Cohort 3 n=7 participants at risk individuals who had received a complete SARS-CoV-2 vaccine course with no known history of natural infection
Skin and subcutaneous tissue disorders Erythema	0.00% 0/1 • 6 months	100.0% 1/1 • Number of events 1 • 6 months	100.0% 7/7 • Number of events 7 • 6 months
General disorders Swelling	100.0% 1/1 • Number of events 1 • 6 months	100.0% 1/1 • Number of events 1 • 6 months	42.9% 3/7 • Number of events 3 • 6 months
Nervous system disorders Presyncope	0.00% 0/1 • 6 months	0.00% 0/1 • 6 months	14.3% 1/7 • Number of events 1 • 6 months
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/1 • 6 months	0.00% 0/1 • 6 months	57.1% 4/7 • Number of events 4 • 6 months

Additional Information

Herb Harris, MD, PhD

Tonix Pharmaceuticals

Phone: (862) 904-0355

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee An industry standard NDA is in place with all study investigators.
Publication restrictions are in place

Restriction type: OTHER