TuberculosisNCT05203068
Specificity Trial of the Recombinant Tuberculosis Allergen in BCG Vaccinated Healthy Volunteers
A study testing Recombinant tuberculosis allergen (RTA) in people with Tuberculosis, run by National Medical Research Center of Phthisiopulmonology and Infectious Diseases at 1 site in Russia.
Trial summary
The aim of this study is to test the recombinant tuberculosis skin test in the previously BCG vaccinated healthy adults with low risk of TB development, to determine the test specificity. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Recombinant tuberculosis allergen (RTA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteRussia
- Study dates
- 24 Nov 2021to 26 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent for the participation in the study.
- Age 18 to 30 years
- A history of BCG vaccination (confirmed by medical documentation and/or the presence of BCG scar)
- Healthy individual according to physical examination and medical records at screening.
- Willingness to cooperate and follow the recommendations of the Investigator in accordance with the Protocol.
Who cannot join
- A history of tuberculosis or close contact with a patient with active tuberculosis for 5 years prior to the enrollment in the study.
- Positive T-SPOT.TB test at the enrollment in the study
- Treatment with drugs affecting immune system within 3 months prior to the enrollment in the study
- Vaccination against any infections <1.5 months prior to the enrollment in the study
- Vaccination with BCG <6 months prior to the enrollment in the study.
- The Mantoux test with 2 TU and/or the test with the recombinant tuberculosis allergen was performed less than 6 months prior to the enrollment in the study.
Show all 18Show fewer
- Congenital or acquired immunodeficiency.
- Active disease of the immune system
- HIV infection.
- The current condition of the skin interferes with the conduct and reading of skin tests (trauma, skin diseases).
- A disease in which blood sampling poses a risk to the volunteer (hemophilia, other bleeding disorders) or obstructed venous access.
- The volunteer currently participates in another clinical study or has participated in another clinical study within 3 months prior to the enrollment in the study.
- Previous participation in clinical studies of ESAT-6 and/or CFP-10 antigens.
- Pregnancy, lactation, pregnancy planning.
- The reluctance of a female person to use effective barrier (including spermicidal gel), hormonal or intrauterine contraceptives during the study.
- History of alcohol, drug, benzodiazepine, or other substance abuse within the 12 months prior to the enrollment in the study.
- Use of alcoholic beverages within 24 hours prior to the visit.
- A condition or disease that, in the opinion of the Investigator, is inappropriate for participation in the study.
Trial locations and contacts
1 site in 1 country.
Russia1 site
National Medical Research Center of Phthisiopulmonology and Infectious Diseases
Moscow
About this study
Official title: Evaluation of the Specificity of Intradermal Test With Recombinant Tuberculosis Allergen in BCG Vaccinated Healthy Volunteers
The aim of this study is to test the recombinant tuberculosis skin test in the previously BCG vaccinated healthy adults with low risk of TB development, to determine the test specificity.
Read the detailed description
Recombinant tuberculosis allergen (RTA) is a recombinant fusion protein CFP10-ESAT6 produced by the prokaryotic cell line. The test is widely used in Russian Federation and CIS countries for the latent TB diagnosis in adults and children over 8 years old. The current clinical study is a prospective, multicenter, open-label study in the cohort of healthy adults, not classified as at risk of tuberculosis, with no clinical symptoms of the disease, with a negative T-SPOT.TB test results, to evaluate the specificity of the RTA test in 72 hours following administration of the product at a dose of 0.2 μg/0.1 mL.
- Conditions
- Tuberculosis
- Being tested
- Recombinant tuberculosis allergen (RTA)
- Keywords
- Tuberculosis, TB diagnosis, Tuberculosis skin test, CFP10, ESAT6
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant tuberculosis allergen (RTA)Diagnostic test
Also called Diaskintest
Single intradermal application of 0.2 µg/0.1 mL RTA (CFP10-ESAT6) in the middle of the forearm
| Study group | Role | What they receive |
|---|---|---|
| Recombinant tuberculosis allergen (CFP10-ESAT6) | Experimental | RTA (CFP10-ESAT6) 0.2 µg/0.1 mL RTA given intradermally on the middle of the forearm Receives: Diagnostic Test: Recombinant tuberculosis allergen (RTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of the Volunteers With the True Negative RTA Result
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
Measured: hour 72
Secondary outcomes (2)
Number of Subjects With Local Adverse Reactions Within 72 Hours Following the Intradermal Test Application
To assess the number of subjects who developed the injection site adverse reaction (redness, swelling etc) within 72 hours after RTA test application
Measured: hour 72
Number of Participants With General and Local Adverse Reactions Within 28 Days After Administration of RTA
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.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start24 Nov 2021
- Primary completion18 Jan 2022
- Study completion26 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Medical Research Center of Phthisiopulmonology and Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Aleksey V. Kazakov, MD, Principal investigator, National Medical Research Center of Phthisiopulmonology and Infectious DiseasesAnastasia G. Samoylova, MD, Study chair, National Medical Research Center of Phthisiopulmonologyand Infectious DiseasesValentina A. Aksyonova, Prof., Study chair, National Medical Research Center of Phtisiopulmonology and Infectious Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203068
- Sponsor's protocol ID
- 102/1
- Status last verified
- Oct 2022
- First submitted
- 9 Jan 2022
- Last updated
- 25 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vasilyeva IA, Aksenova VA, Kazakov AV, Kiseleva YY, Maryandyshev AO, Dolzhenko EN, Abramchenko AV, Klevno NI, Glebov KA, Panova AE, Petrova LY, Sheikis EG, Seregina IV, Nikishova EI, Doktorova NP, Samoilova AG. Evaluation of the specificity of an intradermal test with recombinant tuberculosis allergen in Bacillus Calmette-Guerin-vaccinated healthy volunteers. Front Med (Lausanne). 2023 Mar 1;10:1042461. doi: 10.3389/fmed.2023.1042461. eCollection 2023.
PubMed 36936243
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Specificity of Intradermal Test With Recombinant Tuberculosis Allergen in BCG Vaccinated Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05203068
- Acronym / sponsor ID
- 102/1
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, TB diagnosis, Tuberculosis skin test, CFP10, ESAT6
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- National Medical Research Center of Phthisiopulmonology and Infectious DiseasesOther government
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 18 Jan 2022 (actual)
- Study completion
- 26 Jan 2022 (actual)
- First posted
- 24 Jan 2022 (actual)
- Results
- Posted 25 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to test the recombinant tuberculosis skin test in the previously BCG vaccinated healthy adults with low risk of TB development, to determine the test specificity.
Detailed description
Recombinant tuberculosis allergen (RTA) is a recombinant fusion protein CFP10-ESAT6 produced by the prokaryotic cell line. The test is widely used in Russian Federation and CIS countries for the latent TB diagnosis in adults and children over 8 years old. The current clinical study is a prospective, multicenter, open-label study in the cohort of healthy adults, not classified as at risk of tuberculosis, with no clinical symptoms of the disease, with a negative T-SPOT.TB test results, to evaluate the specificity of the RTA test in 72 hours following administration of the product at a dose of 0.2 μg/0.1 mL.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recombinant tuberculosis allergen (CFP10-ESAT6) | Experimental | Diagnostic Test: Recombinant tuberculosis allergen (RTA)RTA (CFP10-ESAT6) 0.2 µg/0.1 mL RTA given intradermally on the middle of the forearm |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Signed informed consent for the participation in the study.
- Age 18 to 30 years
- A history of BCG vaccination (confirmed by medical documentation and/or the presence of BCG scar)
- Healthy individual according to physical examination and medical records at screening.
- Willingness to cooperate and follow the recommendations of the Investigator in accordance with the Protocol.
Key exclusion criteria (18 listed)
- A history of tuberculosis or close contact with a patient with active tuberculosis for 5 years prior to the enrollment in the study.
- Positive T-SPOT.TB test at the enrollment in the study
- Treatment with drugs affecting immune system within 3 months prior to the enrollment in the study
- Vaccination against any infections <1.5 months prior to the enrollment in the study
- Vaccination with BCG <6 months prior to the enrollment in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant tuberculosis allergen (RTA)Also: DiaskintestSingle intradermal application of 0.2 µg/0.1 mL RTA (CFP10-ESAT6) in the middle of the forearm | Diagnostic test | Recombinant tuberculosis allergen (CFP10-ESAT6) |
Primary outcome
Number of the Volunteers With the True Negative RTA Result
Time frame: 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
2 secondary outcomes
Number of Subjects With Local Adverse Reactions Within 72 Hours Following the Intradermal Test Application
Time frame: hour 72
Number of Participants With General and Local Adverse Reactions Within 28 Days After Administration of RTA
Time frame: Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36936243Vasilyeva IA, Aksenova VA, Kazakov AV, Kiseleva YY, Maryandyshev AO, Dolzhenko EN, Abramchenko AV, Klevno NI, Glebov KA, Panova AE, Petrova LY, Sheikis EG, Seregina IV, Nikishova EI, Doktorova NP, Samoilova AG. Evaluation of the specificity of an intradermal test with recombinant tuberculosis allergen in Bacillus Calmette-Guerin-vaccinated healthy volunteers. Front Med (Lausanne). 2023 Mar 1;10:1042461. doi: 10.3389/fmed.2023.1042461. eCollection 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleksey V. Kazakov, MD principal investigator
National Medical Research Center of Phthisiopulmonology and Infectious Diseases
Anastasia G. Samoylova, MD study chair
National Medical Research Center of Phthisiopulmonologyand Infectious Diseases
Valentina A. Aksyonova, Prof. study chair
National Medical Research Center of Phtisiopulmonology and Infectious Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recombinant tuberculosis allergen (RTA) in people with Tuberculosis, run by National Medical Research Center of Phthisiopulmonology and Infectious Diseases at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of the Volunteers With the True Negative RTA Result (time frame: hour 72). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05203068, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.