A Phase Ib Study of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried (AEC/BCO2)

Summary

Participation Requirements

Description

Single-center, single-dose, placebo-controlled, open-label trials were used to evaluate the safety and immunogenicity of low-dose adjuvants and low-dose vaccines in the upper arm deltoid muscle intramuscularly in the double negative population. Thirty (PPD-QFT-) healthy adult subjects aged 18-45 wer...

Single-center, single-dose, placebo-controlled, open-label trials were used to evaluate the safety and immunogenicity of low-dose adjuvants and low-dose vaccines in the upper arm deltoid muscle intramuscularly in the double negative population. Thirty (PPD-QFT-) healthy adult subjects aged 18-45 were selected and divided into placebo group, low-dose adjuvant group, and low-dose vaccine group. During the test, each subject must not change groups and inoculate drugs. Every two weeks (0-2-4-6-8-10 weeks), alternately inject a dose of placebo or left and right upper arm deltoid muscles. Low-dose adjuvant or low-dose vaccine, a total of 6 doses. Collected adverse events within 14 days after each dose of vaccination, non-recruited adverse events within 30 days after the first dose of vaccination, subjects will receive 6 months follow-up after the last dose of vaccination, and study throughout Serious adverse events were recorded during the period. Immunogenicity will be assessed before the first dose, 24 hours after the third dose, before the fourth dose, 24 hours after the sixth dose, 1 month, and 6 months.

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