TuberculosisPhase 1BCG-PPDNCT06975774
Phase II Clinical Clical of the Pure Protein Derivatives of BCG
A Phase 1 study testing Purified Protein Derivative of BCG（BCG-PPD） in people with Tuberculosis, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
Trial summary
This phase II clinical trial used randomized, double-blind, double-arm intradermal injection, and the same marketed products, selected 30 pulmonary tuberculosis patients aged 18-65 years who met the inclusion criteria and did not meet the exclusion criteria, and conducted the double-arm skin test using BCG-PPD and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Purified Protein Derivative of BCG（BCG-PPD）
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 26 Jul 2023to 15 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject shall be judged as a confirmed tuberculosis patient by a clinician according to Section 5.3.1-5.3.6 of the Health Industry Standards of the People's Republic of China (WS288-2017) (Annex I).(The sampling time can be accepted for the laboratory examination is the examination results of the hospital within 30 days before the skin test);
- Age 18~65, male or female;
- I agree to participate in this trial and sign the informed consent form;
- I am able to follow the follow-up requirements of the clinical trial protocol for follow-up
Who cannot join
- People suffering from acute infectious diseases (such as measles, whooping cough, influenza, pneumonia, etc.), acute ocular conjunctivitis, acute otitis media, extensive skin diseases and allergic constitution;
- Having serious diseases not considered suitable for enrollment by the investigator, such as: advanced tumor, acute onset of chronic obstructive pulmonary disease, acute or progressive liver disease or kidney disease, congestive heart failure, etc.;
- Those treated with immunosuppressants or immune enhancer, or those receiving glucocorticoids, immunoglobulin preparations other than the gastrointestinal tract, or blood products or plasma extracts within 1 month;
- Those who are participating in other new drug clinical trials or have participated in any other new drug clinical trials within 3 months before the clinical trial;
- Women during pregnancy or lactation;
- Patients with mental illness onset period;
- PPD or similar products within 3 months;
- The investigator considered poor compliance, past history, physical examination or laboratory findings.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Double-mal Injection, Control Study of Phase II Clinical Dose Calibration of BCG Pure Protein Derivative (BCG-PPD)
This phase II clinical trial used randomized, double-blind, double-arm intradermal injection, and the same marketed products, selected 30 pulmonary tuberculosis patients aged 18-65 years who met the inclusion criteria and did not meet the exclusion criteria, and conducted the double-arm skin test using BCG-PPD and marketed BCG-PPD controls.
During the screening period, the subjects underwent evidence collection of confirmed tuberculosis, physical examination, vital signs, blood routine, urine routine, blood biochemistry, electrocardiogram, chest CT, HIV antibody test, and blood pregnancy examination of women of childbearing age; Vital signs examination before the skin test, The injection site was photographed 0min after the skin test, Vital signs were performed 30min after the skin test; Vital signs were examined, pictures of the injection site was taken, and the injection site reaction was measured; Observe the skin test response, Record the redness, hardening longitudinal diameter and transverse diameter and other related reactions; All adverse events within 72h after the skin test were recorded and safety evaluated.
Read the detailed description
Prior to the commencement of the study, the Investigator/his authorized officer will contact the subject and/or guardian to enroll the candidate subjects and invite them to participate in the study.Subjects who are eligible for screening receive the drug number in the order they arrive at the random number allocation room.During the screening period, tuberculosis diagnosis evidence collection, physical examination, vital signs, blood routine, urine routine test, blood biochemistry, electrocardiogram, chest CT, HIV antibody test and blood pregnancy examination of women of childbearing age were conducted; after screening, study number (drug number) was assigned, and double arm BCG-PPD skin test with 0.1ml injection. Vital signs should be taken before skin test, injection site photographed 0min and 30min after skin test; vital signs examined, injection site photographed and measured 48-72h after skin test; observe skin test reaction, record red, hard vertical diameter and transverse diameter and other related reactions of skin test; record all adverse events within 72h after skin test and perform safety evaluation.
- Conditions
- Tuberculosis
- Being tested
- Purified Protein Derivative of BCG（BCG-PPD）
- Keywords
- diagnosis of tuberculosis, epidemiological investigation of tuberculosis
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purified Protein Derivative of BCG（BCG-PPD）Drug
Thirty subjects were randomized, double-blinded to perform a homogeneous double-arm BCG-PPD skin test.
| Study group | Role | What they receive |
|---|---|---|
| BCG-PPD under test Is applied to the left arm, while the marketed BCG-PPD Is applied to the right | Experimental | Thirty subjects were randomized, double-blinded to perform a homogeneous double-arm BCG-PPD skin test Receives: Drug: Purified Protein Derivative of BCG（BCG-PPD） |
| BCG-PPD under test Is applied to the right arm, while the marketed BCG-PPD Is applied to the left | Experimental | Thirty subjects were randomized, double-blinded to perform a homogeneous double-arm BCG-PPD skin test Receives: Drug: Purified Protein Derivative of BCG（BCG-PPD） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injection-site reaction endpoint
Evaluate the occurrence of positive reactions，like the transverse and longitudinal diameter of skin redness, induration, and strong positive reactions in 24 hours necrosis, and lymphangitis between 24 hours and 72 hours after the skin test
Measured: Within 24 hours and 48 hours to 72 hours after the skin test
Safety endpoint
The incidence of all adverse events (AES) within 72 hours after drug injection in the subjects;
Measured: Within 72 hours after the skin test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start26 Jul 2023
- Primary completion31 Dec 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shenzhen Third People's Hospital
- Responsible party
- Sponsor
- Investigators
- Lu Shuihua, Bachelor, Principal investigator, Shenzhen Third People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975774
- Sponsor's protocol ID
- LKM-2021-PPD01
- Acronym
- BCG-PPD
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Double-mal Injection, Control Study of Phase II Clinical Dose Calibration of BCG Pure Protein Derivative (BCG-PPD)
- ClinicalTrials.gov ID
- NCT06975774
- Acronym / sponsor ID
- BCG-PPD / LKM-2021-PPD01
- Conditions
- Tuberculosis
- Keywords
- diagnosis of tuberculosis, epidemiological investigation of tuberculosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shenzhen Third People's Hospital
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II clinical trial used randomized, double-blind, double-arm intradermal injection, and the same marketed products, selected 30 pulmonary tuberculosis patients aged 18-65 years who met the inclusion criteria and did not meet the exclusion criteria, and conducted the double-arm skin test using BCG-PPD and marketed BCG-PPD controls.
During the screening period, the subjects underwent evidence collection of confirmed tuberculosis, physical examination, vital signs, blood routine, urine routine, blood biochemistry, electrocardiogram, chest CT, HIV antibody test, and blood pregnancy examination of women of childbearing age; Vital signs examination before the skin test, The injection site was photographed 0min after the skin test, Vital signs were performed 30min after the skin test; Vital signs were examined, pictures of the injection site was taken, and the injection site reaction was measured; Observe the skin test response, Record the redness, hardening longitudinal diameter and transverse diameter and other related reactions; All adverse events within 72h after the skin test were recorded and safety evaluated.
Detailed description
Prior to the commencement of the study, the Investigator/his authorized officer will contact the subject and/or guardian to enroll the candidate subjects and invite them to participate in the study.Subjects who are eligible for screening receive the drug number in the order they arrive at the random number allocation room.During the screening period, tuberculosis diagnosis evidence collection, physical examination, vital signs, blood routine, urine routine test, blood biochemistry, electrocardiogram, chest CT, HIV antibody test and blood pregnancy examination of women of childbearing age were conducted; after screening, study number (drug number) was assigned, and double arm BCG-PPD skin test with 0.1ml injection. Vital signs should be taken before skin test, injection site photographed 0min and 30min after skin test; vital signs examined, injection site photographed and measured 48-72h after skin test; observe skin test reaction, record red, hard vertical diameter and transverse diameter and other related reactions of skin test; record all adverse events within 72h after skin test and perform safety evaluation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCG-PPD under test Is applied to the left arm, while the marketed BCG-PPD Is applied to the right | Experimental | Drug: Purified Protein Derivative of BCG（BCG-PPD）Thirty subjects were randomized, double-blinded to perform a homogeneous double-arm BCG-PPD skin test |
| BCG-PPD under test Is applied to the right arm, while the marketed BCG-PPD Is applied to the left | Experimental | Drug: Purified Protein Derivative of BCG（BCG-PPD）Thirty subjects were randomized, double-blinded to perform a homogeneous double-arm BCG-PPD skin test |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The subject shall be judged as a confirmed tuberculosis patient by a clinician according to Section 5.3.1-5.3.6 of the Health Industry Standards of the People's Republic of China (WS288-2017) (Annex I).(The sampling time can be accepted for the laboratory examination is the examination results of the hospital within 30 days before the skin test);
- Age 18~65, male or female;
- I agree to participate in this trial and sign the informed consent form;
- I am able to follow the follow-up requirements of the clinical trial protocol for follow-up
Key exclusion criteria (8 listed)
- People suffering from acute infectious diseases (such as measles, whooping cough, influenza, pneumonia, etc.), acute ocular conjunctivitis, acute otitis media, extensive skin diseases and allergic constitution;
- Having serious diseases not considered suitable for enrollment by the investigator, such as: advanced tumor, acute onset of chronic obstructive pulmonary disease, acute or progressive liver disease or kidney disease, congestive heart failure, etc.;
- Those treated with immunosuppressants or immune enhancer, or those receiving glucocorticoids, immunoglobulin preparations other than the gastrointestinal tract, or blood products or plasma extracts within 1 month;
- Those who are participating in other new drug clinical trials or have participated in any other new drug clinical trials within 3 months before the clinical trial;
- Women during pregnancy or lactation;
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 |
|---|---|---|
| Purified Protein Derivative of BCG（BCG-PPD）Thirty subjects were randomized, double-blinded to perform a homogeneous double-arm BCG-PPD skin test. | Drug | BCG-PPD under test Is applied to the left arm, while the marketed BCG-PPD Is applied to the right, BCG-PPD under test Is applied to the right arm, while the marketed BCG-PPD Is applied to the left |
Primary outcome
Injection-site reaction endpoint
Time frame: Within 24 hours and 48 hours to 72 hours after the skin test
Evaluate the occurrence of positive reactions，like the transverse and longitudinal diameter of skin redness, induration, and strong positive reactions in 24 hours necrosis, and lymphangitis between 24 hours and 72 hours after the skin test
Safety endpoint
Time frame: Within 72 hours after the skin test
The incidence of all adverse events (AES) within 72 hours after drug injection in the subjects;
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No
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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.
Lu Shuihua, Bachelor principal investigator
Shenzhen Third People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Purified Protein Derivative of BCG（BCG-PPD） in people with Tuberculosis, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
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 4 inclusion and 8 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 16 May 2025. 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 China. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Injection-site reaction endpoint (time frame: Within 24 hours and 48 hours to 72 hours after the skin test). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2025.