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Recombinant fusion ESAT6-CFP10 immunogen as a skin test reagent for tuberculosis diagnosis in children and adolescents:An open-label,randomized,multicenter phase Ⅲ trial

Lu Xia Xu-hui Liu Miao Xu Ting Zhang Guo-zhi Wang Bao-dong Yuan Feng Li Guo-xi Chen Xi-rong Wu Yan Guo Ting Song A-dong Shen Tao Li Shui-hua Lu

LabMed Discovery2025，Vol.2Issue(2)：P.1-6,6.

LabMed Discovery2025，Vol.2Issue(2)：P.1-6,6.DOI:10.1016/j.lmd.2025.100072

Recombinant fusion ESAT6-CFP10 immunogen as a skin test reagent for tuberculosis diagnosis in children and adolescents:An open-label,randomized,multicenter phase Ⅲ trial

Lu Xia ¹Xu-hui Liu ¹Miao Xu ²Ting Zhang ³Guo-zhi Wang ²Bao-dong Yuan ⁴Feng Li ⁵Guo-xi Chen ⁴Xi-rong Wu ⁶Yan Guo ⁶Ting Song ⁷A-dong Shen ⁸Tao Li ⁹Shui-hua Lu¹⁰

作者信息

1. Department of Tuberculosis,Shanghai Public Health Clinical Center,Fudan University,Shanghai 200083,China Tuberculosis Research Center,Shanghai Public Health Clinical Center,Fudan University,Shanghai 200083,China
2. National Health Commission Key Laboratory of Research on Quality and Standardization of Biotech Products,National Institutes for Food and Drug Control,Beijing102629,China
3. Department of Gastroenterology,Children’s Hospital of Shanghai,Shanghai 200040,China
4. Department of Tuberculosis,Wuhan Pulmonary Hospital,Wuhan 430030,Hubei,China
5. Department of Tuberculosis,Shanghai Public Health Clinical Center,Fudan University,Shanghai 200083,China
6. Respiratory Department,Beijing Children’s Hospital,Capital Medical University,China National Clinical Research Center of Respiratory Diseases,National Center for Children’s Health,Beijing 100101,China
7. Tuberculosis Research Center,Shanghai Public Health Clinical Center,Fudan University,Shanghai 200083,China
8. National Clinical Research Center for Respiratory Diseases,National Key Discipline of Pediatrics,Capital Medical University,Key Laboratory of Major Diseases in Children,Ministry of Education,National Center for Children’s Health,Beijing Children’s Hospital,Beijing 100045,China
9. Tuberculosis Research Center,Shanghai Public Health Clinical Center,Fudan University,Shanghai 200083,China Department of Infectious Diseases,Huashan Hospital,Fudan University,Shanghai 200040,China
10. Tuberculosis Research Center,Shanghai Public Health Clinical Center,Fudan University,Shanghai 200083,China National Clinical Research Center for Infectious Diseases,Shenzhen Third People’s Hospital,Shenzhen 102206,Guangdong,China
折叠

摘要

关键词

Tuberculosis(TB)/Tuberculosis infection(TBI)/Creation tuberculin skin test(C-TST)/Secreted antigenic target 6-kDa protein-culture/filtrate protein 10(ESAT6-CFP10)/Skin test/Serious adverse events(AEs)

分类

医药卫生

引用本文复制引用

Lu Xia,Xu-hui Liu,Miao Xu,Ting Zhang,Guo-zhi Wang,Bao-dong Yuan,Feng Li,Guo-xi Chen,Xi-rong Wu,Yan Guo,Ting Song,A-dong Shen,Tao Li,Shui-hua Lu..Recombinant fusion ESAT6-CFP10 immunogen as a skin test reagent for tuberculosis diagnosis in children and adolescents:An open-label,randomized,multicenter phase Ⅲ trial[J].LabMed Discovery,2025,2(2):P.1-6,6.

基金项目

supported by Anhui Longcom Biologic Pharmacy Co.Ltd.,China （）

This study received grant support from the Clinical Research Project of Shanghai Public Health Clinical Center of China(No.KY-GW-2024-01) （No.KY-GW-2024-01）

research start-up funds for introduced talents of Shanghai Public Health Clinical Center of China(No.RCJJ2025-08). （No.RCJJ2025-08）

LabMed Discovery

ISSN：3050-4740

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