TuberculosisPhase 1NCT04593771
Phase I Clinical Protocol of BCG-PPD in Healthy People
A Phase 1 study testing BCG-PPD in people with Tuberculosis, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
Trial summary
A total of 80 healthy people aged 65 years and below who are randomly assigned to the experimental group and the control group. The experimental group is injected with BCG-PPD test drug once, and the control group is injected with BCG-PPD control drug once.Subjects will undergo physical examination, vital signs, blood… Read more about this study
- Who is it for?
- Ages Up to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- BCG-PPD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 21 Oct 2020to 24 May 2021
- 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 Up to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age 0-65 (including 65 years old), male and female.
- I (and/or my guardian) agree to participate in the study and sign the informed consent.
- I (and/or guardian) can comply with the requirements of the clinical trial protocol to participate in the follow-up.
- No history of tuberculosis, family history of tuberculosis, and history of close contact with tuberculosis (refers to direct contact with registered tuberculosis patients from 3 months before their diagnosis to 14 days after the start of anti-tuberculosis treatment).
- No pulmonary or external tuberculosis, and no respiratory symptoms or other systemic symptoms of tuberculosis.
- Medical history of careless, liver, kidney, digestive tract, nervous system, mental and metabolic abnormalities after signing the informed consent.
- Vital signs (body temperature (axillary temperature) < 37.3℃, blood pressure (people aged 18 and over: systolic blood pressure < 140mmHg, diastolic blood pressure < 90mmHg);People aged 6 to 17: systolic blood pressure < 120mmHg, diastolic blood pressure < 80mmHg;No abnormal blood pressure, pulse rate 50 ~ 100 times /min, electrocardiogram, physical examination or abnormality has no clinical significance.
- Laboratory tests, including blood routine, urine routine and blood biochemical tests, showed no abnormalities or abnormalities had no clinical significance.
Who cannot join
- Patients with acute infectious diseases (such as measles, pertussis, influenza, pneumonia, etc.), acute ophthalmic membranitis, acute otitis media, generalized skin diseases and allergic constitution (people with allergy history to two or more drugs or foods, or known allergy and scar constitution to this drug component)
- Subjects have any serious disease, such as: tumor, progressive atherosclerosis or diabetes with complications, chronic obstructive pulmonary disease requiring oxygen therapy, acute or progressive liver or kidney disease, congestive heart failure, etc.
- A history of convulsion, epilepsy, mental illness and/or a family history of mental illness.
- is known or suspected (or has a high risk might) damage or abnormal immune function, such as immune inhibitors or immune enhancer treatment, in 3 months to accept glucocorticoid, outside of the gastrointestinal tract immunoglobulin preparations or blood products or plasma extract, human immunodeficiency virus infection or related diseases.
- The test results of human immunodeficiency virus (HIV) antibody are positive
- Before enrollment, the interval between inoculation of live attenuated vaccine is less than 28 days, and the interval between inoculation of other vaccines is less than 14 days
Show all 14Show fewer
- In the acute stage of disease or acute onset of chronic disease (3 days before skin test)
- Is participating in or has participated in any other clinical investigator within 3 months prior to this clinical study
- pregnant or lactating women, or planning to become pregnant during the study period.
- On-site inquiry for drug abuse and alcohol abuse.
- Persons with upper extremity disabilities
- Birth weight less than 2.5kg, or premature and difficult birth (for infants under one year of age)
- Newborn with respiratory distress syndrome, pathological jaundice, congenital malformations, developmental disorders and congenital diseases (for infants under 1 year of age)
- The investigator believes that there are any conditions such as poor compliance that may affect the evaluation of the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Sichuan Center for Disease Control and Prevention
Chengdu, Sichuan, 610041
About this study
Official title: Randomized, Blinded, Single-arm Intradermal Injection, Control of Similar Products on the Market, the Safety Pre-evaluation Phase I Clinical Trial of BCG-PPD in Healthy People
A total of 80 healthy people aged 65 years and below who are randomly assigned to the experimental group and the control group. The experimental group is injected with BCG-PPD test drug once, and the control group is injected with BCG-PPD control drug once.Subjects will undergo physical examination, vital signs, blood routine, urine routine, blood biochemistry, electrocardiogram, HIV antibody test and blood pregnancy test for women of childbearing age during the screening period.Vital signs were checked before skin test, the injection site was photographed at 0min after skin test, and vital signs were checked at 30min after skin test.Vital signs examination, injection site photography and injection site reaction measurement were performed 48h and 72h after skin test.Physical examination, vital signs, routine blood test, routine urine test, biochemical test, electrocardiogram and blood pregnancy test of women of childbearing age were performed again 7 days after skin test to evaluate the safety of BCG-PPD.
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, physical examination, vital signs, blood routine, urine routine, blood biochemistry, electrocardiogram, HIV antibody test and blood pregnancy test (only women of childbearing age).Inverstigator absorb and inject 0.1ml drug into the upper and middle 1/3 of the left forearm by Mondo's method. The reaction of the injection site was checked and photographed at 0min, 48h and 72h after the skin test. Meanwhile, the transverse and longitudinal diameers of skin induration and redness were measured at 48h and 72h after the skin test.Vital signs are checked at 30min after skin test.Vital signs examination, injection site photography and reaction measurement are performed 48h and 72h after skin test.Physical examination, vital signs, routine blood test, routine urine test, biochemical test, electrocardiogram and blood pregnancy test are performed again 7 days after skin test.All AE occurred within 7 days after skin test were recorded by a diary card. AE related to the test drug should be followed up to the end of the event.Skin test of subjects aged 18-45 years shall be conducted first. After safety assessment, skin test of subjects aged 46-65 years old, 6-17 years old and under 6 years old shall be conducted successively.
- Conditions
- Tuberculosis
- Being tested
- 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.
BCG-PPDDrug
BCG-PPD was used for skin test in 40 healthy people, and BCG-PPD was marketed in other 40 healthy people (as control)
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 80 healthy people were randomly assigned to the experimental group and the control group. The experimental group was injected with BCG-PPD once. Receives: Drug: BCG-PPD |
| control group | Other | 80 healthy people were randomly assigned to the experimental group and the control group. The control group was injected with BCG-PPD was marketed once. Receives: Drug: BCG-PPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the incidence of all adverse event and results of laboratory tests
Record and evaluate the incidence of all adverse event within 7 days after injection；Record and evaluate abnormal incidence of blood routine, urine routine, blood biochemical and electrocardiogram indicators 7 days after injection
Measured: 7 days after injection
Evaluate the effectiveness of the product by measuring the size of the skin response
The transverse and longitudinal diameters (millimetre) of skin induration and redness, as well as local double circles, blisters, necrosis, and lymphangitis, were recorded at 48h and 72h after injection
Measured: 48 to 72 hours after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start21 Oct 2020
- Primary completion24 May 2021
- Study completion24 May 2021
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sichuan Center for Disease Control and Prevention, Neijiang Center for Disease Control and Prevention, Beijing Kangterike Statistical Technology Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Ting Huang, Master, Principal investigator, Sichuan Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593771
- Sponsor's protocol ID
- LKM-2020-PPD01
- Status last verified
- Feb 2022
- First submitted
- 27 Sep 2020
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Blinded, Single-arm Intradermal Injection, Control of Similar Products on the Market, the Safety Pre-evaluation Phase I Clinical Trial of BCG-PPD in Healthy People
- ClinicalTrials.gov ID
- NCT04593771
- Acronym / sponsor ID
- LKM-2020-PPD01
- Conditions
- Tuberculosis
- Keywords
- diagnosis of tuberculosis, epidemiological investigation of tuberculosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Sichuan Center for Disease Control and Prevention, Neijiang Center for Disease Control and Prevention, Beijing Kangterike Statistical Technology Co., Ltd.
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 24 May 2021 (actual)
- Study completion
- 24 May 2021 (actual)
- First posted
- 20 Oct 2020 (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.
A total of 80 healthy people aged 65 years and below who are randomly assigned to the experimental group and the control group. The experimental group is injected with BCG-PPD test drug once, and the control group is injected with BCG-PPD control drug once.Subjects will undergo physical examination, vital signs, blood routine, urine routine, blood biochemistry, electrocardiogram, HIV antibody test and blood pregnancy test for women of childbearing age during the screening period.Vital signs were checked before skin test, the injection site was photographed at 0min after skin test, and vital signs were checked at 30min after skin test.Vital signs examination, injection site photography and injection site reaction measurement were performed 48h and 72h after skin test.Physical examination, vital signs, routine blood test, routine urine test, biochemical test, electrocardiogram and blood pregnancy test of women of childbearing age were performed again 7 days after skin test to evaluate the safety of BCG-PPD.
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, physical examination, vital signs, blood routine, urine routine, blood biochemistry, electrocardiogram, HIV antibody test and blood pregnancy test (only women of childbearing age).Inverstigator absorb and inject 0.1ml drug into the upper and middle 1/3 of the left forearm by Mondo's method. The reaction of the injection site was checked and photographed at 0min, 48h and 72h after the skin test. Meanwhile, the transverse and longitudinal diameers of skin induration and redness were measured at 48h and 72h after the skin test.Vital signs are checked at 30min after skin test.Vital signs examination, injection site photography and reaction measurement are performed 48h and 72h after skin test.Physical examination, vital signs, routine blood test, routine urine test, biochemical test, electrocardiogram and blood pregnancy test are performed again 7 days after skin test.All AE occurred within 7 days after skin test were recorded by a diary card. AE related to the test drug should be followed up to the end of the event.Skin test of subjects aged 18-45 years shall be conducted first. After safety assessment, skin test of subjects aged 46-65 years old, 6-17 years old and under 6 years old shall be conducted successively.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: BCG-PPD80 healthy people were randomly assigned to the experimental group and the control group. The experimental group was injected with BCG-PPD once. |
| control group | Other | Drug: BCG-PPD80 healthy people were randomly assigned to the experimental group and the control group. The control group was injected with BCG-PPD was marketed once. |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Age 0-65 (including 65 years old), male and female.
- I (and/or my guardian) agree to participate in the study and sign the informed consent.
- I (and/or guardian) can comply with the requirements of the clinical trial protocol to participate in the follow-up.
- No history of tuberculosis, family history of tuberculosis, and history of close contact with tuberculosis (refers to direct contact with registered tuberculosis patients from 3 months before their diagnosis to 14 days after the start of anti-tuberculosis treatment).
- No pulmonary or external tuberculosis, and no respiratory symptoms or other systemic symptoms of tuberculosis.
Key exclusion criteria (14 listed)
- Patients with acute infectious diseases (such as measles, pertussis, influenza, pneumonia, etc.), acute ophthalmic membranitis, acute otitis media, generalized skin diseases and allergic constitution (people with allergy history to two or more drugs or foods, or known allergy and scar constitution to this drug component)
- Subjects have any serious disease, such as: tumor, progressive atherosclerosis or diabetes with complications, chronic obstructive pulmonary disease requiring oxygen therapy, acute or progressive liver or kidney disease, congestive heart failure, etc.
- A history of convulsion, epilepsy, mental illness and/or a family history of mental illness.
- is known or suspected (or has a high risk might) damage or abnormal immune function, such as immune inhibitors or immune enhancer treatment, in 3 months to accept glucocorticoid, outside of the gastrointestinal tract immunoglobulin preparations or blood products or plasma extract, human immunodeficiency virus infection or related diseases.
- The test results of human immunodeficiency virus (HIV) antibody are positive
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 |
|---|---|---|
| BCG-PPDBCG-PPD was used for skin test in 40 healthy people, and BCG-PPD was marketed in other 40 healthy people (as control) | Drug | Experimental group, control group |
Primary outcome
Evaluate the incidence of all adverse event and results of laboratory tests
Time frame: 7 days after injection
Record and evaluate the incidence of all adverse event within 7 days after injection；Record and evaluate abnormal incidence of blood routine, urine routine, blood biochemical and electrocardiogram indicators 7 days after injection
Evaluate the effectiveness of the product by measuring the size of the skin response
Time frame: 48 to 72 hours after injection
The transverse and longitudinal diameters (millimetre) of skin induration and redness, as well as local double circles, blisters, necrosis, and lymphangitis, were recorded at 48h and 72h after injection
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 22 Feb 2022.
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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.
Ting Huang, Master principal investigator
Sichuan Center for Disease Control and Prevention
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 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 8 inclusion and 14 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 22 Feb 2022. 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?
Evaluate the incidence of all adverse event and results of laboratory tests (time frame: 7 days after injection). 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 22 Feb 2022.