Simoon Record Pharma Information Consulting Co., Ltd.

A total of 13500 Chinese women aged 18-45 years old were divided into three age groups: 18-26 years old, 27-35 years old, and 35-45 years old. The experimental group and the placebo group were randomly assigned in a ratio of 1:1. All subjects enrolled in the upper arm deltoid muscle were injected with 3 doses of test vaccine or placebo according to the 0, 2, and 6 months immunization program.

This study is a continuation study of the original V-01-I phase trial, using a single-center, single-arm, open design to evaluate the immunogenicity and safety of the third dose booster immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in healthy participants immunized with two doses schedule of V-01.
The primary objective is to evaluate the Immunogenicity of the third dose booster immunization of V-01 in healthy participants immunized with two doses schedule of V-01.
The secondary objective is to evaluate the safety of the third dose booster immunization of V-01 in healthy participants immunized with two doses schedule of V-01.

A total of 60 TB patients 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 undergoing physical examination, vital signs, blood routine, urine routine, blood biochemistry, electrocardiogram, chest X-ray, tuberculosis culture, tuberculosis smear, HIV antibody test and blood pregnancy（only women of childbearing age） during the screening period.Vital signs were checked before skin test, the injection site is photographed at 0min after skin test, and 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 to evaluate the safety of BCG-PPD.