Trial Outcomes & Findings for Specificity Trial of the Recombinant Tuberculosis Allergen in BCG Vaccinated Healthy Volunteers (NCT NCT05203068)

Results Overview

Absolute number and percentage of the volunteers with negative and positive test results with RTA based on the results of the assessment of the infiltrate 72 hours after the test application

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

150 participants

Primary outcome timeframe

hour 72

Results posted on

2023-08-25

Participant Flow

Participant milestones

Participant milestones
Measure	Recombinant Tuberculosis Allergen (CFP10-ESAT6) RTA (CFP10-ESAT6) 0.2 µg/0.1 mL RTA given intradermally on the middle of the forearm Recombinant tuberculosis allergen (RTA): Single intradermal application of 0.2 µg/0.1 mL RTA (CFP10-ESAT6) in the middle of the forearm
RTA Result Assessment, 72 Hours STARTED	150
RTA Result Assessment, 72 Hours COMPLETED	150
RTA Result Assessment, 72 Hours NOT COMPLETED	0
RTA Safety Assessment, 28 Days STARTED	150
RTA Safety Assessment, 28 Days COMPLETED	150
RTA Safety Assessment, 28 Days NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Recombinant Tuberculosis Allergen (CFP10-ESAT6) n=150 Participants RTA (CFP10-ESAT6) 0.2 µg/0.1 mL RTA given intradermally on the middle of the forearm Recombinant tuberculosis allergen (RTA): Single intradermal application of 0.2 µg/0.1 mL RTA (CFP10-ESAT6) in the middle of the forearm
Age, Continuous	21.5 years n=150 Participants
Sex: Female, Male Female	122 Participants n=150 Participants
Sex: Female, Male Male	28 Participants n=150 Participants
Region of Enrollment Russia	150 participants n=150 Participants
Body weight	60 kilograms n=150 Participants
BCG-vaccination history	150 Participants n=150 Participants
Having allergic diseases in the past	148 Participants n=150 Participants
Having chronic diseases	8 Participants n=150 Participants
COVID-19 vaccinated	145 Participants n=150 Participants

PRIMARY outcome

Timeframe: hour 72

Absolute number and percentage of the volunteers with negative and positive test results with RTA based on the results of the assessment of the infiltrate 72 hours after the test application

Outcome measures

Outcome measures
Measure	Recombinant Tuberculosis Allergen (CFP10-ESAT6) n=150 Participants RTA (CFP10-ESAT6) 0.2 µg/0.1 mL RTA given intradermally on the middle of the forearm Recombinant tuberculosis allergen (RTA): Single intradermal application of 0.2 µg/0.1 mL RTA (CFP10-ESAT6) in the middle of the forearm
Number of the Volunteers With the True Negative RTA Result Count RTA negative	145 Participants
Number of the Volunteers With the True Negative RTA Result Count RTA positive	5 Participants

SECONDARY outcome

Timeframe: hour 72

To assess the number of subjects who developed the injection site adverse reaction (redness, swelling etc) within 72 hours after RTA test application

Outcome measures

Outcome measures
Measure	Recombinant Tuberculosis Allergen (CFP10-ESAT6) n=150 Participants RTA (CFP10-ESAT6) 0.2 µg/0.1 mL RTA given intradermally on the middle of the forearm Recombinant tuberculosis allergen (RTA): Single intradermal application of 0.2 µg/0.1 mL RTA (CFP10-ESAT6) in the middle of the forearm
Number of Subjects With Local Adverse Reactions Within 72 Hours Following the Intradermal Test Application	0 Participants

SECONDARY outcome

Timeframe: Day 28

To assess the number of subjects who developed the general adverse reaction (e.g. infections, fever, headache, weakness etc) based on the subjects complaints and physical examination, and local injection site reaction (redness, swelling etc) up to 28 days after intradermal RTA application.

Outcome measures

Outcome measures
Measure	Recombinant Tuberculosis Allergen (CFP10-ESAT6) n=150 Participants RTA (CFP10-ESAT6) 0.2 µg/0.1 mL RTA given intradermally on the middle of the forearm Recombinant tuberculosis allergen (RTA): Single intradermal application of 0.2 µg/0.1 mL RTA (CFP10-ESAT6) in the middle of the forearm
Number of Participants With General and Local Adverse Reactions Within 28 Days After Administration of RTA Number of participants developed general adverse reaction in 28 days after RTA application	1 Participants
Number of Participants With General and Local Adverse Reactions Within 28 Days After Administration of RTA Number of participants developed local adverse reactions in 28 days after RTA application	0 Participants
Number of Participants With General and Local Adverse Reactions Within 28 Days After Administration of RTA Number of participants without adverse reactions in 28 days after RTA application	149 Participants

Adverse Events

Recombinant Tuberculosis Allergen (CFP10-ESAT6)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Recombinant Tuberculosis Allergen (CFP10-ESAT6) n=150 participants at risk RTA (CFP10-ESAT6) 0.2 µg/0.1 mL RTA given intradermally on the middle of the forearm Recombinant tuberculosis allergen (RTA): Single intradermal application of 0.2 µg/0.1 mL RTA (CFP10-ESAT6) in the middle of the forearm
Infections and infestations Respiratory tract infection	0.67% 1/150 • Number of events 1 • 28 days

Additional Information

Dr. Kazakov Aleksey Vladimirovich, principal investigator

Federal State Budgetary Institution "National Medical Research Center of Phthisiopulmonology and Infectious Diseases" of the Ministry of Health of the Russian Federation

Phone: +79254666638

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place