Phase I Clinical Protocol of BCG-PPD in Healthy People

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.

Study Overview

• Status: Completed
• Conditions: Tuberculosis
• Intervention / Treatment: Drug: 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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chendu, Sichuan, China, 610041
      • Sichuan Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 0-65 (including 65 years old), male and female.
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.
4. 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).
5. No pulmonary or external tuberculosis, and no respiratory symptoms or other systemic symptoms of tuberculosis.
6. Medical history of careless, liver, kidney, digestive tract, nervous system, mental and metabolic abnormalities after signing the informed consent.
7. 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.
8. Laboratory tests, including blood routine, urine routine and blood biochemical tests, showed no abnormalities or abnormalities had no clinical significance.

Exclusion Criteria:

1. 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)
2. 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.
3. A history of convulsion, epilepsy, mental illness and/or a family history of mental illness.
4. 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.
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. Is 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. On-site inquiry for drug abuse and alcohol abuse.
11. Persons with upper extremity disabilities
12. Birth weight less than 2.5kg, or premature and difficult birth (for infants under one year of age)
13. Newborn with respiratory distress syndrome, pathological jaundice, congenital malformations, developmental disorders and congenital diseases (for infants under 1 year of age)
14. The investigator believes that there are any conditions such as poor compliance that may affect the evaluation of the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 80 healthy people were randomly assigned to the experimental group and the control group. The experimental group was injected with BCG-PPD once.	Drug: BCG-PPD; BCG-PPD was used for skin test in 40 healthy people, and BCG-PPD was marketed in other 40 healthy people (as control)
Other: control group; 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.	Drug: BCG-PPD; BCG-PPD was used for skin test in 40 healthy people, and BCG-PPD was marketed in other 40 healthy people (as control)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	48 to 72 hours after injection

Collaborators and Investigators

• Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
• Collaborators: Sichuan Center for Disease Control and Prevention; Neijiang Center for Disease Control and Prevention; Beijing Kangterike Statistical Technology Co., Ltd.
• Investigators: Principal Investigator: Ting Huang, Master, Sichuan Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2020
• Primary Completion (Actual): May 24, 2021
• Study Completion (Actual): May 24, 2021

Study Registration Dates

• First Submitted: September 27, 2020
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (Actual): October 20, 2020

Study Record Updates

• Last Update Posted (Actual): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 21, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: diagnosis of tuberculosis; epidemiological investigation of tuberculosis
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: LKM-2020-PPD01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No