NCT04538911

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tuberculosis

Interventions

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

Timeline

• Start date: 2021-07-02
• Primary completion: 2023-05-18
• Completion: 2025-12-01
• First posted: 2020-09-04
• Last updated: 2024-12-11

Locations

1 site across 1 country: China