姓  名

李靖欣

性  别

女

出生年月

1982.09

民  族

汉族

职  务

疫苗临床评价所副所长

职  称

主任医师

学  历

博士研究生

毕业院校

第三军医大学

专业特长

从事疫苗临床流行病学和疫苗免疫策略研究工作10余年。在新发突发传染病疫苗的免疫策略研究、应急疫苗临床评价关键技术攻关、重大传染病防控和免疫防疫科技储备等方面有丰富的经验。

任职（目前担任省级以上学术委员会委员以上职务的）

1. 2021.09-至今，任江苏省药学会第二届药物临床评价研究专业委员会委员

2. 2020.11-2025.11，任中国疫苗行业协会核酸疫苗分会委员

3. 2020.11-2025.11，任中华预防医学会疫苗临床研究专业委员会常务委员

4. 2019.07-2024.07，任中华预防医学会流行病学分会青年委员

科研成果（近五年）

科技奖项：

2022年，江苏省科学技术奖（应急疫苗临床评价关键技术体系构建及应用）二等奖，排名1

科研项目：

1. 2023.01-2025.12，国家自然科学基金优秀青年科学基金项目“疫苗免疫策略临床评价关键技术及应用”，排名1

2. 2022.07-2025.06，江苏省自然科学基金杰出青年科学基金项目“疫苗免疫策略及临床评价”，排名1

3. 2023.12-2026.11，国家重点研发计划“病原学与防疫技术体系研究”重点专项子课题“疫苗免疫保护效应及安全性特征研究”，排名1

4. 2022.01-2025.12，国家自然科学基金面上项目“腺病毒载体新冠疫苗与灭活新冠疫苗诱导的免疫应答特征及序贯免疫策略研究”，排名1

发明专利：

1. 2021年，一种抗新型冠状病毒的单克隆抗体或其衍生体（ZL202010467983.5），排名8

2. 2020年，一种全人源抗H7N9病毒的中和抗体（ZL201710231198.8），排名3

3. 2020年，分离的新型冠状病毒单克隆抗体或其抗原结合部分（ZL202010468939.6），排名4

发表论文：

近五年共发表论文85篇，其中包含SCI论文66篇。

获奖情况（近五年）

2022年江苏省科技奖二等奖，排名1；

2023年，江苏省行业领域（生物医药领域）十大科技进展“新冠疫苗黏膜免疫策略临床研究及应用”，排名2

学术论文、论著（近五年）

1.  Wang WX, Li JX. Even a Small Stride Can Have a Significant Impact: Enhancing the Effectiveness of Influenza Vaccines. Infectious Diseases & Immunity 4(2):p 56-57, April 2024.（通讯）

2.  Zhu Y, Tang R, Li X, Chen X, Wang X, Wang Y, Wang R, Zhu F, Li J. Vaccination with Adenovirus Type 5 Vector-Based COVID-19 Vaccine as the Primary Series in Adults: A Randomized, Double-Blind, Placebo-Controlled Phase 1/2 Clinical Trial. Vaccines (Basel). 2024 Mar 11;12(3):292.（通讯）

3.  Jia S, Yin Z, Pan H, Wang F, Liu X, Wang Q, Zhang L, Tang J, Yang H, Du J, Wang Z, Jin P, Peng Z, Tang R, Kang G, Wang X, Li S, Wang W, Li J, Shen H, Zhu F. Relative effectiveness of a heterologous booster dose with adenovirus type 5 vectored COVID-19 vaccine versus three doses of inactivated COVID-19 vaccine in adults during a nationwide outbreak of omicron predominance, in China: a retrospective, individually matched cohort-control study. Emerg Microbes Infect. 2024 Dec;13(1):2332660.（通讯）

4.  Balgos A, Hannawi S, Chen WL, Abuquta A, Safeldin L, Hassan A, Alamadi A, Tirador L, Jaen AM, Villalobos RE, Mo C, Yue ZJ, Ma Y, Wang QS, Wen RD, Yao Z, Yu JP, Yao WR, Zhang JH, Hong KX, Liu Y, Li JX. Immunogenicity and safety of boosting with a recombinant two-component SARS-CoV-2 vaccine: two randomized, parallel-controlled, phase 2 studies. Expert Rev Vaccines. 2024 Jan-Dec;23(1):419-431.（通讯）

5.  Fang Y, Li JX, Duangdany D, Li Y, Guo XL, Phamisith C, Yu B, Shen MY, Luo B, Wang YZ, Liu SJ, Zhao FF, Xu CC, Qiu XH, Yan R, Gui YZ, Pei RJ, Wang J, Shen H, Guan WX, Li HW, Mayxay M. Safety, immunogenicity, and efficacy of a modified COVID-19 mRNA vaccine, SW-BIC-213, in healthy people aged 18 years and above: a phase 3 double-blinded, randomized, parallel controlled clinical trial in Lao PDR (Laos). EClinicalMedicine. 2023 Dec 13;67:102372.（共同一作）

6.  Wynne C, Balgos A, Li J, Hamilton P, Tirador L, Jaen AM, Mo C, Yue Z, Ma Y, Wang Q, Wen R, Yao Z, Yu J, Yao W, Zhang J, Zheng H, Hong K, Zhu F, Liu Y. Safety and Immunogenicity of a Recombinant Two-Component SARS-CoV-2 Protein Vaccine: Randomized, Double-Blind, Placebo-Controlled Phase I and Phase II Studies. Infect Dis Ther. 2024 Jan;13(1):57-78.（共同一作）

7.  Li JX, Hou LH, Gou JB, Yin ZD, Wu SP, Wang FZ, Zhang Z, Peng ZH, Zhu T, Shen HB, Chen W, Zhu FC; Six-Province COVID-19 Vaccine Study Group. Safety, immunogenicity and protection of heterologous boost with an aerosolised Ad5-nCoV after two-dose inactivated COVID-19 vaccines in adults: a multicentre, open-label phase 3 trial. Lancet Infect Dis. 2023 Oct;23(10):1143-1152.（第一作者）

8.  Xia X, Tan ZM, Wan P, Zheng H, Tang R, Chen XQ, Guo XL, Zhu T, Feng JL, Zhong J, Li XL, Zhang ZY, Zhu FC, Li JX. Environmental Impact Assessment for the Use of an Orally Aerosolized Adenovirus Type-5 Vector-Based COVID-19 Vaccine in Randomized Clinical Trials. J Infect Dis. 2023 Sep 15;228(6):715-722.（通讯）

9.  Jin PF, Guo XL, Gou JB, Hou LH, Song ZZ, Zhu T, Pan HX, Zhu JH, Shi FJ, Du P, Huang HT, Liu JX, Zheng H, Wang X, Chen Y, Wan P, Wu SP, Wang XW, Xu XY, Yan FR, Li JX, Chen W, Zhu FC. Immunogenicity and safety of heterologous immunisation with Ad5-nCOV in healthy adults aged 60 years and older primed with an inactivated SARS-CoV-2 vaccine (CoronaVac): a phase 4, randomised, observer-blind, non-inferiority trial. Lancet Reg Health West Pac. 2023 Jun 20;38:100829.（通讯）

10. Wu JD, Li JX, Liu J, Wang HM, Zhou GH, Li J, Wu D, Chen X, Feng Y, Qi XY, Wang X, Gou JB, Ma TL, Yang XY, Xu LF, Wan P, Zhu T, Wang ZF, Zhu FC; CanSino COVID-19 Study Group. Safety, immunogenicity, and efficacy of the mRNA vaccine CS-2034 as a heterologous booster versus homologous booster with BBIBP-CorV in adults aged ≥18 years: a randomised, double-blind, phase 2b trial. Lancet Infect Dis. 2023 Sep;23(9):1020-1030.（共同一作）

11. Tang R, Zheng H, Wang BS, Gou JB, Guo XL, Chen XQ, Chen Y, Wu SP, Zhong J, Pan HX, Zhu JH, Xu XY, Shi FJ, Li ZP, Liu JX, Zhang XY, Cui LB, Song ZZ, Hou LH, Zhu FC, Li JX; CanSino COVID-19 Study Group. Safety and immunogenicity of aerosolised Ad5-nCoV, intramuscular Ad5-nCoV, or inactivated COVID-19 vaccine CoronaVac given as the second booster following three doses of CoronaVac: a multicentre, open-label, phase 4, randomised trial. Lancet Respir Med. 2023 Jul;11(7):613-623.（通讯）

12. Gui YZ, Li XN, Li JX, Shen MY, Zhang MW, Cao Y, Xu HR, Li H, Cheng J, Pan L, Yi YL, Liang LY, Yu CY, Liu GY, Yu C, Hu BJ, Zhu FC, Liang F, Shen H, Jia JY, Li HW, Zhou J, Fan J. Safety and immunogenicity of a modified COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults: an open-labeled, two-centered and multi-arm randomised, phase 1 trial. EBioMedicine. 2023 May;91:104586.（共同一作）

13. Wang SY, Liu WQ, Li YQ, Li JX, Zhu FC. A China-developed adenovirus vector-based COVID-19 vaccine: review of the development and application of Ad5-nCov. Expert Rev Vaccines. 2023 Jan-Dec;22(1):704-713.（通讯）

14. Feng JL, Wang WJ, Jin PF, Zheng H, Jin LR, Xia X, Zhang XY, Li ZP, Li JX, Zhu FC. Comparison of antibody persistency through one year between one-dose and two-dose regimens of Ad5-nCoV vaccine for COVID-19. Hum Vaccin Immunother. 2023 Aug 1;19(2):2230760.（通讯）

15. Wu YF, Wei MW, Wang RJ, Guo XL, Pan HX, Gao YC, Li XL, Wang X, Ma XM, Wan P, Zhou L, Zhu YW, Li JX, Zhu FC. Immunogenicity consistency and safety with different production scales of recombinant adenovirus type-5 vectored COVID-19 vaccine in healthy adults: a randomized, double-blinded, immunobridging trial. Expert Rev Vaccines. 2023 Jan-Dec;22(1):662-670.（通讯）

16. Zhang X, Xia J, Jin L, Wu Y, Zheng X, Cao X, Meng X, Li J, Zhu F. Effectiveness of homologous or heterologous immunization regimens against SARS-CoV-2 after two doses of inactivated COVID-19 vaccine: A systematic review and meta-analysis. Hum Vaccin Immunother. 2023 Aug 1;19(2):2221146.（通讯）

17. Jin L, Tang R, Wu S, Guo X, Huang H, Hou L, Chen X, Zhu T, Gou J, Zhong J, Pan H, Cui L, Chen Y, Xia X, Feng J, Wang X, Zhao Q, Xu X, Li Z, Zhang X, Chen W, Li J, Zhu F. Antibody persistence and safety after heterologous boosting with orally aerosolised Ad5-nCoV in individuals primed with two-dose CoronaVac previously: 12-month analyses of a randomized controlled trial. Emerg Microbes Infect. 2023 Dec;12(1):2155251.（通讯）

18. Hui AM, Li J, Zhu L, Tang R, Ye H, Lin M, Ge L, Wang X, Peng F, Wu Z, Guo X, Shi Y, Pan H, Zhu J, Song Z, Qiu J, Wang W, Zheng J, Ozhelvaci O, Shpyro S, Bushway M, Derhovanessian E, Kühnle MC, Luxemburger U, Muik A, Shishkova Y, Khondker Z, Hu S, Lagkadinou E, Şahin U, Türeci Ö, Zhu F. Immunogenicity and safety of BNT162b2 mRNA vaccine in Chinese adults: A phase 2 randomised clinical trial. Lancet Reg Health West Pac. 2022 Dec;29:100586.（共同一作）

19. Li JX, Wu SP, Guo XL, Tang R, Huang BY, Chen XQ, Chen Y, Hou LH, Liu JX, Zhong J, Pan HX, Shi FJ, Xu XY, Li ZP, Zhang XY, Cui LB, Tan WJ, Chen W, Zhu FC; CanSino COVID-19 Study Group. Safety and immunogenicity of heterologous boost immunisation with an orally administered aerosolised Ad5-nCoV after two-dose priming with an inactivated SARS-CoV-2 vaccine in Chinese adults: a randomised, open-label, single-centre trial. Lancet Respir Med. 2022 Aug;10(8):739-748.（第一作者）

20. Li J, Hui AM, Zhang X, Ge L, Qiu Y, Tang R, Ye H, Wang X, Lin M, Zhu Z, Zheng J, Qiu J, Lagkadinou E, Shpyro S, Ozhelvaci O, Türeci Ö, Khondker Z, Yin W, Shishkova Y, Jia S, Pan H, Peng F, Ma Z, Wu Z, Guo X, Shi Y, Muik A, Şahin U, Zhu L, Zhu F. Immune Persistence and Safety After SARS-CoV-2 BNT162b1 mRNA Vaccination in Chinese Adults: A Randomized, Placebo-Controlled, Double-Blind Phase 1 Trial. Adv Ther. 2022 Aug;39(8):3789-3798.（第一作者）

21. Li JX, Zhu FC. The S-Trimer (SCB-2019) COVID-19 vaccine and reinfection with SARS-CoV-2. Lancet Infect Dis. 2022 Jul;22(7):916-917. doi: 10.1016/S1473-3099(22)00162-1.（第一作者）

22. Jin P, Guo X, Chen W, Ma S, Pan H, Dai L, Du P, Wang L, Jin L, Chen Y, Shi F, Liu J, Xu X, Zhang Y, Gao GF, Chen C, Feng J, Li J, Zhu F. Safety and immunogenicity of heterologous boost immunization with an adenovirus type-5-vectored and protein-subunit-based COVID-19 vaccine (Convidecia/ZF2001): A randomized, observer-blinded, placebo-controlled trial. PLoS Med. 2022 May 26;19(5):e1003953.（通讯）

23. Li J, Hou L, Guo X, Jin P, Wu S, Zhu J, Pan H, Wang X, Song Z, Wan J, Cui L, Li J, Chen Y, Wang X, Jin L, Liu J, Shi F, Xu X, Zhu T, Chen W, Zhu F. Heterologous AD5-nCOV plus CoronaVac versus homologous CoronaVac vaccination: a randomized phase 4 trial. Nat Med. 2022 Feb;28(2):401-409.（第一作者）

24. Jingxin Li, Zhuopei Li, Yawen Zhu, Li Zhou, Fengcai Zhu. Evidence of the Efficacy and the Effectiveness of First Generation COVID-19 Vaccines in Clinical Trials and Real-world Studies. Zoonoses. 2022. Vol. 2(1).（第一作者）

25. Li ZP, Shi YF, Hou LH, Jin PF, Ma SH, Pan HX, Zhang JL, Shan YM, Huang HT, Wu SP, Du P, Wang X, Wang LL, Wang RJ, Wang Y, Wang XW, Zhu FC, Li JX. Batch-to-batch consistency trial of an adenovirus type-5 vector-based COVID-19 vaccine in adults aged 18 years and above. Expert Rev Vaccines. 2022 Dec;21(12):1843-1849.（通讯）

26. Jin L, Li Z, Zhang X, Li J, Zhu F. CoronaVac: A review of efficacy, safety, and immunogenicity of the inactivated vaccine against SARS-CoV-2. Hum Vaccin Immunother. 2022 Nov 30;18(6):2096970.（通讯）

27. Jiang HD, Guo XL, Jin PF, Tang R, Li JX, Zhu FC. Head-to-head comparisons of the neutralizing antibody against SARS-CoV-2 variants elicited by four priming-boosting regimens. Emerg Microbes Infect. 2022 Dec;11(1):1751-1753.（通讯）

28. Zhang L, Jin P, Wei M, Jiang H, Li J, Zhu F. A comparison of the test-negative and the matched case-control study designs for estimation of EV71 vaccine immunological surrogate endpoints from a randomized controlled trial. Hum Vaccin Immunother. 2022 Nov 30;18(5):2073751.（通讯）

29. Gao S, Wei M, Chu K, Li J, Zhu F. Effects of maternal antibodies in infants on the immunogenicity and safety of inactivated polio vaccine in infants. Hum Vaccin Immunother. 2022 Nov 30;18(5):2050106.（通讯）

30. Fan L, Zhang L, Li J, Zhu F. Advances in the progress of monoclonal antibodies for rabies. Hum Vaccin Immunother. 2022 Dec 31;18(1):2026713.（通讯）

31. Li JX, Zhu FC. Inactivated SARS-CoV-2 vaccine (BBV152)-induced protection against symptomatic COVID-19. Lancet. 2021 Dec 11;398(10317):2134-2135.（第一作者）

32. Jin P, Li J, Pan H, Wu Y, Zhu F. Immunological surrogate endpoints of COVID-2019 vaccines: the evidence we have versus the evidence we need. Signal Transduct Target Ther. 2021 Feb 2;6(1):48.（共同一作）

33. Li JX, Zhu FC. Adjuvantation helps to optimise COVID-19 vaccine candidate. Lancet Infect Dis. 2021 Jul;21(7):891-893.（第一作者）

34. Li J, Hui A, Zhang X, Yang Y, Tang R, Ye H, Ji R, Lin M, Zhu Z, Türeci Ö, Lagkadinou E, Jia S, Pan H, Peng F, Ma Z, Wu Z, Guo X, Shi Y, Muik A, Şahin U, Zhu L, Zhu F. Safety and immunogenicity of the SARS-CoV-2 BNT162b1 mRNA vaccine in younger and older Chinese adults: a randomized, placebo-controlled, double-blind phase 1 study. Nat Med. 2021 Jun;27(6):1062-1070.（第一作者）

35. Wang Y, Li J, Dai P, Liu P, Zhu F. Effectiveness of the oral human attenuated pentavalent rotavirus vaccine (RotaTeq™) postlicensure: a meta-analysis-2006-2020. Expert Rev Vaccines. 2021 Apr;20(4):437-448.（共同一作）

36. Zhang L, Wei M, Jin P, Li J, Zhu F. An evaluation of a test-negative design for EV-71 vaccine from a randomized controlled trial. Hum Vaccin Immunother. 2021 Jul 3;17(7):2101-2106.（通讯）

37. Cao JQ, Jin PF, Li JX, Zeng ZZ, Zhang L, Meng FY, Chu K, Wang YY, Zhu FC. Effects of Prior Influenza Exposure on Immunogenicity of Influenza Vaccine. Open Forum Infect Dis. 2020 May 26;7(8):ofaa181.（共同一作）

38. Zhang L, Yu C, Ge Z, Tao H, Meng F, Xu X, Tian T, Song C, Hu Z, Li J, Zhu F. Whole exome sequencing reveals the different responsiveness to Enterovirus 71 vaccination in Chinese children. Int J Infect Dis. 2020 Aug;97:47-53.（通讯）

39. 张笑银, 吴燕飞, 金来润, 朱凤才, 李靖欣. 阶梯设计在疫苗临床研究中的应用[J]. 中国预防医学杂志, 1-7.（通讯）

40. 胡文婧, 金来润, 王家琪, 曹祥, 朱凤才, 李靖欣. 人体挑战试验在疫苗临床评价中的应用[J]. 中国疫苗和免疫, 2024, 30 (01): 87-94.（通讯）

41. 刘倩, 金来润, 金鹏飞, 朱凤才, 李靖欣.. Ⅱ/Ⅲ期无缝设计在疫苗临床试验中的应用[J]. 中华流行病学杂志, 2024, 45 (4): 602-607.（通讯）

42. 周利, 金鹏飞, 魏明伟, 朱雅文, 朱凤才, 李靖欣. 呼吸道黏膜免疫疫苗临床研究进展和应用[J]. 中国疫苗和免疫, 2023, 29 (06): 727-734.（通讯）

43. 朱雅文, 夏芯, 李镯沛, 吴燕飞, 朱凤才, 李靖欣. 桥接试验设计在预防性疫苗临床研究中的应用[J]. 中华预防医学杂志, 2023, 57 (12): 2201-2211.（通讯）

44. 夏芯, 朱雅文, 周利, 朱凤才, 李靖欣. 疫苗新型佐剂的作用机制和研发进展综述[J]. 中国疫苗和免疫, 2023, 29 (04): 474-482.（通讯）

45. 王远舟, 贾斯月, 朱凤才, 李靖欣. COVID-19疫情下肺结核病人的COVID-19疫苗接种策略[J]. 中华疾病控制杂志, 2022, 26(11): 1344-1348.（通讯）

46. 李镯沛, 朱凤才, 李靖欣. 重组病毒载体新型冠状病毒疫苗的临床研究进展[J]. 中华预防医学杂志, 2022, 56(8): 1127-1135.（通讯）

47. 高书瑜, 李靖欣, 金鹏飞, 朱凤才. 整群随机设计在疫苗临床试验中的应用[J]. 中华流行病学杂志, 2021, 42(12):2221-2225.（共同一作）

48. 金鹏飞, 张力, 李靖欣, 朱凤才. 科学理性解读COVID-19疫苗Ⅲ期临床保护效力数据[J]. 科学通报, 2021, 66 (09): 980-986.（通讯）

49. 张力, 金鹏飞, 李靖欣, 朱凤才.  检测阴性设计在疫苗效果评价中的应用 [J] . 中华流行病学杂志, 2020, 41 (02): 280-283.（通讯）