Clinical Study of BCG Vaccine for Intradermal Injection
Randomized, Blinded, Placebo-Controlled Phase I Clinical Trial to Evaluate the Safety and Tolerability of BCG Vaccine for Intradermal Injection in 6-65 Year Olds
1 other identifier
interventional
160
1 country
1
Brief Summary
The study used a randomized, dose-escalation, blinded, placebo-controlled trial design. In this trial, 160 subjects were enrolled. The test vaccines are divided into four dose groups: dose group 1 (0.025mg / 0.1ml / person), dose group 2 (0.05mg / 0.1ml / person), dose group 3 (0.075mg / 0.1ml / person), dose group 4 (0.1mg / 0.1ml / person), each Each dose group was enrolled according to 18-45、 46-65 、6-10、11-17years old . The 4 doses are in descending order in the order of 18-45, 46-65, 11-17, and 6-10 years old. Each age group in the same dose group was enrolled in 8 experimental BCG subjects and 2 placebo subjects. Among subjects aged 6-65 years, the dose group 2 study will be carried out after the safety assessment 14 days after the dose group 1 vaccination, and the dose group 3 study will be carried out after completing the safety assessment 14 days after the dose group 2 vaccination. Dose group 3 studies were carried out after safety assessment 14 days after vaccination. Within the same dose group, after completing the safety assessment 14 days after vaccination for the previous age group, vaccination for the next age group is carried out.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2020
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2020
CompletedFirst Posted
Study publicly available on registry
September 24, 2020
CompletedStudy Start
First participant enrolled
October 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2022
CompletedMay 9, 2023
May 1, 2023
2 years
June 19, 2020
May 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of adverse events after vaccination
Evaluate safety indicators before vaccination, 30 minutes, 7 days, and 14 days after vaccination. Collect all AEs 30 minutes after vaccination, 0-14 days of collected adverse events, 0-30 days of non-collected adverse events, within 6 months SAE, to evaluate the safety and tolerability of BCG vaccine for intradermal injection used in the test in people aged 6 to 65 years old with negative BCG-PPD and EC skin test
Up to 6 months after the sixth time injection
Secondary Outcomes (2)
Positive conversion rate of BCG-PPD skin test 12 weeks and 6 months after vaccination
Up to 6 months after the sixth time injection
Positive conversion rate of EC skin test 12 weeks and 6 months after vaccination
Up to 6 months after the sixth time injection
Study Arms (4)
Healthy people aged 18-45
EXPERIMENTALHealthy people aged 18-45 has 40 subjects,and it is considered as BCG purified protein derivative(BCG-PPD) skin test and Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10（EC） detection result all negative.
Healthy people aged 46-65
EXPERIMENTALHealthy people aged 46-65 has 40 subjects,and it is considered as BCG purified protein derivative(BCG-PPD) skin test and Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10（EC） detection result all negative.
Healthy people aged 11-17.
EXPERIMENTALHealthy people aged 11-17 40 subjects,and it is considered as BCG purified protein derivative(BCG-PPD) skin test and Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10（EC） detection result all negative.
Healthy people aged 6-10
EXPERIMENTALHealthy people aged 6-10 has 40 subjects,and it is considered as BCG purified protein derivative(BCG-PPD) skin test and Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10（EC） detection result all negative.
Interventions
Intradermal injection of 0.025mg/0.1ml/person dose BCG.
Intradermal injection of 0.05mg/0.1ml/person dose BCG.
Intradermal injection of 0.075mg/0.1ml/person dose BCG.
Intradermal injection of 0.075mg/0.1ml/person dose BCG.
Intradermal injection of 0.1ml/person dose Placebo.
Eligibility Criteria
You may qualify if:
- Aged 6-65 years old, able to provide legal identification;
- The guardian and/or I agree to participate in this trial, and have the ability to understand the research procedures and sign an informed consent form, and are willing and able to comply with the requirements of the research protocol;
- The female agrees to have no birth plan within 180 days after participating in the research and voluntarily take effective contraceptive measures;
- There is no contraindication to BCG vaccination (①Known allergy to any component of this vaccine; ②Patients suffering from acute disease, severe chronic disease, acute episode of chronic disease and fever; ③Immune deficiency, immunocompromised or receiving immunosuppression Treatment; ④patients with encephalopathy, uncontrolled epilepsy and other progressive neurological diseases; ⑤pregnant women; ⑥patients with eczema or other skin diseases), no history of tuberculosis;
- There are no contraindications to the use of BCG-PPD and EC (patients suffering from acute infectious diseases (such as measles, pertussis, influenza, pneumonia, etc.), acute conjunctivitis, acute otitis media, patients with extensive skin diseases and allergic constitution);
- According to the medical history, physical examination and laboratory index test results, the investigator judges to be healthy (for example: no history of tumor, abnormal laboratory index but no clinical significance);
- The average diameter of BCG-PPD 48-hour skin test induration is less than 5mm without double circles, blisters, necrosis and lymphangitis. The average diameter of EC 48-hour skin test induration and redness is less than 5mm without blisters, necrosis, and lymphangitis. reaction.
You may not qualify if:
- Any previous history of severe side effects of vaccines or drugs, such as urticaria, dyspnea, angioedema;
- The interval between inoculation of live attenuated vaccine is less than 28 days, and the interval of other vaccines is less than 14 days;
- Those who have a history of convulsions, epilepsy, mental illness and/or family history of mental illness;
- Human immunodeficiency virus (HIV) antibody test results are positive;
- Have received blood or blood-related products within 3 months before screening;
- A history of drug abuse upon inquiry;
- Women who are breastfeeding;
- Those who have participated in other clinical trials in the past 3 months and used study drugs;
- years old systolic blood pressure ≥120mmHg and/or diastolic blood pressure ≥80 mmHg; 18-65 years old diastolic blood pressure ≥90mmHg and/or systolic blood pressure ≥140mmHg;
- Those with axillary body temperature ≥37.3℃;
- Disabled upper limbs;
- The researcher believes that the subject has any conditions that may affect the evaluation of the research purpose.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sichuan Center for Disease Control and Prevention
Chengdu, Sichuan, 610041, China
Related Publications (2)
Tuberculosis Prevention Trial. Trial of BCG vaccines in south India for tuberculosis prevention. 1979. Indian J Med Res. 2013 Mar;137(3):571. No abstract available.
PMID: 23776969BACKGROUNDExpanded programme on immunization. Immunization schedules in the WHO European Region, 1995. Wkly Epidemiol Rec. 1995 Aug 4;70(31):221. No abstract available. English, French.
PMID: 7662525BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ting Huang, Master
Sichuan Provincial Center for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2020
First Posted
September 24, 2020
Study Start
October 21, 2020
Primary Completion
October 30, 2022
Study Completion
October 30, 2022
Last Updated
May 9, 2023
Record last verified: 2023-05