Clinical Study of BCG Vaccine for Intradermal Injection
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      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.

      BCG-PPD and EC skin test were performed during the screening period, and the skin test
      results were followed up at 48 hours; blood routine, urine routine, blood biochemistry, HIV
      antibody test, electrocardiogram, chest X-ray examination, physical examination, vital signs
      (heart rate, blood pressure) And body temperature), female subjects of childbearing age
      undergo a blood pregnancy test. Those eligible for entry will receive a dose of the trial
      vaccine or placebo on the same day (day 0); Observe vital signs (heart rate, blood pressure
      and body temperature), reactions at the inoculation site, and reactions at the
      non-inoculation site at 30 minutes, 7 days, and 14 days after vaccination; Blood routine,
      urine routine, blood biochemistry, electrocardiogram examination on the 14th day after
      vaccination; BCG-PPD and EC skin tests were performed on the 84th and 180th days after
      inoculation.

      If the blood routine, urine routine, blood biochemistry, electrocardiogram examinations after
      vaccination are abnormal and have clinically meaningful results, a re-test is required. Under
      special circumstances, the number of re-tests can be appropriately increased until the
      follow-up outcome.
    

Intervention name(s): BCG vaccine 1（0.025mg/0.1ml/person）; BCG vaccine 2 （0.05mg/0.1ml/person）; BCG vaccine 3（0.075mg/0.1ml/person）; BCG vaccine 4 （0.075mg/0.1ml/person）; Placebo of BCG vaccine （0.1ml/person）
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 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.
Intervention MeSH terms: Vaccines; BCG Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Tuberculosis