Clinical Study of BCG Vaccine for Intradermal Injection

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.

Timeline

Start

2020-10-21

Primary completion

2022-10-30

Completion

2022-10-30

Publications

• Background 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.
• Background Expanded 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.

Drugs

Indications