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Phase I Clinical Protocol for Pre-evaluation of the Safety of BCG-PPD in Tuberculosis Patients

Primary Purpose

Tuberculosis

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
BCG-PPD
Sponsored by
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Tuberculosis focused on measuring diagnosis of tuberculosis, epidemiological investigation of tuberculosis

Eligibility Criteria

undefined - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Inclusion criteria for tuberculosis patients:

    1. Subjects aged 15 ~ 65 years (including 15 and 65 years old) who are clinically diagnosed or diagnosed with tuberculosis.
    2. Subjects under the age of 15 (excluding those under the age of 15) who are clinically diagnosed or diagnosed with tuberculosis.
    3. I (and/or my guardian) agree to participate in the study and sign the informed consent.
    4. I (and/or guardian) can comply with the requirements of the clinical trial protocol to participate in the follow-up.
  • Inclusion criteria for patients with extrapulmonary tuberculosis:

    1. The patient was diagnosed with extrapulmonary tuberculosis by epidemiology, clinical manifestations, imaging examination, etiology examination, pathology examination and other auxiliary examinations, and the tuberculosis focus involved other parts of the lung.Combined with the characteristics of this clinical study and field implementation, the inclusion of patients with extrapulmonary tuberculosis should meet the "chemotherapy intensification period not completed".
    2. I (and/or my guardian) agree to participate in the study and sign the informed consent.
    3. I (and/or guardian) can comply with the requirements of the clinical trial protocol to participate in the follow-up.

Exclusion Criteria:

  1. Suffering from acute infectious diseases (such as measles, pertussis, influenza, pneumonia, etc.), acute ophthalmic membranitis, acute otitis media, extensive skin diseases and allergic constitution(A history of allergy to two or more drugs or foods, or a known allergy and scar constitution to this drug component).
  2. People 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.
  3. Convulsion, epilepsy, history of mental illness and/or family history of mental illness.
  4. Patients with known or suspected (or high-risk) immune function impairment or abnormality,For example, patients receiving immunosuppressive or immunobooster therapy, patients receiving glucocorticoids, immunoglobulin preparations or blood products or plasma extracts outside the gastrointestinal tract within 3 months, human immunodeficiency virus infection or related diseases.
  5. The test results of human immunodeficiency virus (HIV) antibody are positive.
  6. 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.
  7. In the acute stage of disease or acute onset of chronic disease (3 days before skin test).
  8. People are participating in or has participated in any other clinical investigator within 3 months prior to this clinical study.
  9. Pregnant or lactating women, or planning to become pregnant during the study period.
  10. A clear history of hypertension.
  11. Suspected or confirmed drug abuse or alcohol abuse.
  12. persons with upper limb disabilities.
  13. Infants (under one year of age) whose birth weight is less than 2.5kg, or premature or refractory infants.
  14. Infants (under 1 year of age) suffering from neonatal respiratory distress syndrome, pathological jaundice, congenital malformations, developmental disorders and congenital diseases.
  15. The investigator believes that there are any conditions such as poor compliance that may affect the evaluation of the trial.

Sites / Locations

  • The Third People's Hospital Of ShenzhenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental group

control group

Arm Description

30 tuberculosis patient were randomly assigned to the experimental group and the control group. The experimental group was injected with BCG-PPD drug once, while the control group was injected with BCG-PPD drug once

30 tuberculosis patient were randomly assigned to the experimental group and the control group. The experimental group was injected with BCG-PPD drug once, while the control group was injected with BCG-PPD drug once

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
August 28, 2020
Last Updated
May 6, 2023
Sponsor
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Collaborators
Shenzhen Third People's Hospital, Beijing Kangterike Statistical Technology Co., Ltd., Wuhan Pulmonary Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04538911
Brief Title
Phase I Clinical Protocol for Pre-evaluation of the Safety of BCG-PPD in Tuberculosis Patients
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 Tuberculosis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 2, 2021 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Collaborators
Shenzhen Third People's Hospital, Beijing Kangterike Statistical Technology Co., Ltd., Wuhan Pulmonary Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A total of 60 TB patients 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 undergoing physical examination, vital signs, blood routine, urine routine, blood biochemistry, electrocardiogram, chest X-ray, tuberculosis culture, tuberculosis smear, HIV antibody test and blood pregnancy(only women of childbearing age) during the screening period.Vital signs were checked before skin test, the injection site is photographed at 0min after skin test, and 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 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.They have to undergoing physical examination, vital signs, blood routine, urine routine, blood biochemistry, electrocardiogram, chest X-ray, tuberculosis culture, tuberculosis smear, HIV antibody test and blood pregnancy(only women of childbearing age) during the screening period. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
diagnosis of tuberculosis, epidemiological investigation of tuberculosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Randomized, blinded, single-arm intradermal injection, comparison of similar products on the market
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The statistician and the blind operators who do not participate in the trial will perform drug blinding,stick the printed drug label on the designated position of each drug according to the blind bottom. After completing the blind programming, the blind bottom will be sealed and handed over to the sponsor. The blind editors shall not participate in other related work of this clinical trial, and shall not disclose to any personnel participating in the trial.Subjects were randomly injected intracutaneously with BCG-PPD test drugs or BCG-PPD control drugs.All subjects, some investigators and other staff participating in the study were kept blind.The investigators designated in the study to extract drugs are non-blind personnel, and are not allowed to disclose the subject's grouping and skin test information to others, nor are they allowed to participate in any other procedures in the trial.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
30 tuberculosis patient were randomly assigned to the experimental group and the control group. The experimental group was injected with BCG-PPD drug once, while the control group was injected with BCG-PPD drug once
Arm Title
control group
Arm Type
Other
Arm Description
30 tuberculosis patient were randomly assigned to the experimental group and the control group. The experimental group was injected with BCG-PPD drug once, while the control group was injected with BCG-PPD drug once
Intervention Type
Drug
Intervention Name(s)
BCG-PPD
Intervention Description
BCG-PPD was used for skin test in 30 TB patients, and BCG-PPD was marketed in other 30 TB patients (as control)
Primary Outcome Measure Information:
Title
Evaluate the incidence of all adverse event and results of laboratory tests
Description
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
Time Frame
7 days after injection
Title
Evaluate the effectiveness of the product by measuring the size of the skin response
Description
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
Time Frame
Between 48 and 72 hours after injection

10. Eligibility

Sex
All
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion criteria for tuberculosis patients: Subjects aged 15 ~ 65 years (including 15 and 65 years old) who are clinically diagnosed or diagnosed with tuberculosis. Subjects under the age of 15 (excluding those under the age of 15) who are clinically diagnosed or diagnosed with tuberculosis. 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. Inclusion criteria for patients with extrapulmonary tuberculosis: The patient was diagnosed with extrapulmonary tuberculosis by epidemiology, clinical manifestations, imaging examination, etiology examination, pathology examination and other auxiliary examinations, and the tuberculosis focus involved other parts of the lung.Combined with the characteristics of this clinical study and field implementation, the inclusion of patients with extrapulmonary tuberculosis should meet the "chemotherapy intensification period not completed". 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. Exclusion Criteria: Suffering from acute infectious diseases (such as measles, pertussis, influenza, pneumonia, etc.), acute ophthalmic membranitis, acute otitis media, extensive skin diseases and allergic constitution(A history of allergy to two or more drugs or foods, or a known allergy and scar constitution to this drug component). People 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. Convulsion, epilepsy, history of mental illness and/or family history of mental illness. Patients with known or suspected (or high-risk) immune function impairment or abnormality,For example, patients receiving immunosuppressive or immunobooster therapy, patients receiving glucocorticoids, immunoglobulin preparations or blood products or plasma extracts outside the gastrointestinal tract within 3 months, 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. In the acute stage of disease or acute onset of chronic disease (3 days before skin test). People are 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. A clear history of hypertension. Suspected or confirmed drug abuse or alcohol abuse. persons with upper limb disabilities. Infants (under one year of age) whose birth weight is less than 2.5kg, or premature or refractory infants. Infants (under 1 year of age) suffering from neonatal respiratory distress syndrome, pathological jaundice, congenital malformations, developmental disorders and congenital diseases. The investigator believes that there are any conditions such as poor compliance that may affect the evaluation of the trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuihua Lu, Bachelor
Phone
+86-18930811818
Email
lushuihua@shphc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Lifeng Tao, Bachelor
Phone
+86-18110910397
Email
taolifeng@zhifeishengwu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuihua Lu, Bachelor
Organizational Affiliation
Shenzhen Third People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hai Huang, Bachelor
Organizational Affiliation
Wuhan Pulmonary Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guan Liu, Master
Organizational Affiliation
Wuhan Pulmonary Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Third People's Hospital Of Shenzhen
City
Shenzhen
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuihua Lu, Bachelor
Phone
+86-18930811818
Email
lushuihua@shphc.org.cn

12. IPD Sharing Statement

Learn more about this trial

Phase I Clinical Protocol for Pre-evaluation of the Safety of BCG-PPD in Tuberculosis Patients

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