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

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.

NCT Number	NCT04538911
Lead Sponsor	Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. Collaborators: Shenzhen Third People's Hospital, Beijing Kangterike Statistical Technology Co., Ltd., Wuhan Pulmonary Hospital
Conditions	Tuberculosis
Enrollment	60 participants
Start Date	2021-07-02
Primary Completion	2023-05-18 (estimated)
Study Completion	2025-12 (estimated)
Updated on ClinicalTrials.gov	2024-12-11