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

NCT04538911 | Active Not Recruiting Phase 1

• 1 other identifier: LKM-2020-PPD02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis

Keywords

diagnosis of tuberculosis; epidemiological investigation of tuberculosis

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Between 48 and 72 hours after injection

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Drug: BCG-PPD

control group

OTHER

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

Drug: BCG-PPD

Interventions

BCG-PPD DRUG

BCG-PPD was used for skin test in 30 TB patients, and BCG-PPD was marketed in other 30 TB patients (as control)

Experimental group; control group

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.: lead
• Shenzhen Third People's Hospital: collaborator
• Beijing Kangterike Statistical Technology Co., Ltd.: collaborator
• Wuhan Pulmonary Hospital: collaborator

Study Sites (1)

The Third People's Hospital Of Shenzhen

Shenzhen, Guangdong, China

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Shuihua Lu, Bachelor

  Shenzhen Third People's Hospital

  PRINCIPAL INVESTIGATOR

• Hai Huang, Bachelor

  Wuhan Pulmonary Hospital

  PRINCIPAL INVESTIGATOR

• Guan Liu, Master

  Wuhan Pulmonary Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 4, 2020
• Study Start: July 2, 2021
• Primary Completion: May 18, 2023
• Study Completion: December 1, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

CN (1)