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SINOVAC科兴新冠疫苗克尔来福®在特殊人群中的应用研究概览
2022-04-21

截至2022年3月底,由科兴控股生物技术有限公司(下称“SINOVAC科兴”)研制的克尔来福®已在61个国家/地区/国际组织获批,在56个国家和地区使用,并在全球范围内针对适种人群展开了诸多临床及真实世界研究。同时,克尔来福®在特殊健康状况人群中也积累了大量的应用经验,显示出良好的安全性、免疫原性及有效性。


克尔来福®在特殊人群中的应用研究



免疫功能低下/异常者

免疫功能低下

https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciac167/6543937?login=true

艾滋病病毒(HIV)感染2

https://www.sciencedirect.com/science/article/pii/S2352301822000339

自身免疫性风湿性疾病3

https://link.springer.com/article/10.1007/s00296-021-05017-9

全身性红斑狼疮4

https://onlinelibrary.wiley.com/doi/full/10.1002/acr.24824

多发性硬化症

https://doi.org/10.1016/j.msard.2022.103690

干燥综合症6

https://link.springer.com/article/10.1007/s10067-022-06134-x


内分泌疾病患者

甲状腺功能减退症7

https://www.liebertpub.com/doi/abs/10.1089/thy.2021.0684

糖尿病、肥胖症8

https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3822780


肾脏系统疾病患者

非透析肾病9

https://doi.org/10.1101/2022.01.14.22269182

肾移植受者10

https://journals.lww.com/transplantjournal/Fulltext/2022/01000/Clinical_Impact,_Reactogenicity,_and.40.aspx


心血管疾病患者

高血压8、冠心病等(在研,暂无数据)


其他

腹膜透析人群11

https://academic.oup.com/ckj/article/14/12/2612/6353597?login=false

癌症患者12

https://www.futuremedicine.com/doi/full/10.2217/fon-2021-1248

孕妇13 

https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-022-02353-w

产妇14

https://www.medrxiv.org/content/10.1101/2021.12.14.21267777v1

既往新冠病毒感染者(在研,暂无数据)



部分特殊人群研究结果如下


孕、产妇


2021年3月至10月,巴西近2万名孕妇接种两剂克尔来福®后,对新冠病毒有症状感染的保护效果为41%(95% CI 27.1 - 52.2),对重症的保护效果为85%(95% CI 59.4–94.8),在接种至少一剂克尔来福®的孕妇中无人死亡[13]


2021年4月至8月,巴西孕、产妇人群共接种170万剂不同类型新冠疫苗,据安全性观察研究结果显示:克尔来福®总体不良事件发生率较巴西同期使用的另3款新冠疫苗更低,不良事件以1级为主,无严重不良事件发生,安全性良好14



图片关键词

克尔来福®安全性良好

优于巴西同期使用的另3款新冠疫苗



恶性实体瘤患者


2021年3月至7月,土耳其一项针对776名恶性实体瘤患者(试验组)和715名无恶性实体瘤人群(对照组)的前瞻性、多中心队列研究结果显示:克尔来福在恶性实体瘤患者患者中应用安全、有效12


试验组血清阳性率为85.2%,对照组血清阳性率为97.5%,恶性实体瘤患者的高血清阳性率表明这些患者接种克尔来福®可有效预防新冠感染。对照组接种第1剂后不良反应发生率显著高于患者,患者组接种第1剂后不良反应发生率为15.9%,对照组的发生率为22.5%,对照组最常见的不良反应是局部疼痛(9.7%),患者组最常见的不良反应是疲劳(6.4%)。由此可见,克尔来福在该人群中安全性良好,不良反应发生率低,且大多为轻度不良反应。


图片关键词

恶性实体瘤患者接种克尔来福

不良反应发生率略低于健康人群


艾滋病病毒(HIV)感染者


2021年2月至3月,巴西一项针对215名HIV感染者(试验组)和296名健康人群(对照组)的前瞻性队列研究结果显示:HIV感染者接种克尔来福后的安全性和免疫原性良好2


图片关键词

HIV感染者接种克尔来福

不良事件发生率与健康人群相当

风湿病患者


墨西哥一项针对225名自身免疫性风湿病患者横断面研究显示,患者接种疫苗后可产生免疫应答,在六种疫苗中,克尔来福不良事件发生率最低,安全性更好3 。

 

世界卫生组织建议,中度和重度免疫功能低下或缺陷人群(如恶性肿瘤患者、器官移植患者、正在使用免疫抑制剂治疗患者、艾滋病病毒感染者等人群)感染新冠病毒后重症风险较高,且接种疫苗后的有效性和免疫原性较低。因此,上述人群应尽快接种加强剂次/补充剂次来增强免疫应答并提供额外的保护15



参考文献

[1] Balcells, M. Elvira, et al. "Reduced immune response to inactivated SARS-CoV-2 vaccine in a cohort of immunocompromised patients in Chile." Clinical Infectious Diseases (2022). https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciac167/6543937?login=true

[2] Netto, Lucas C., et al. "Safety and immunogenicity of CoronaVac in people living with HIV: a prospective cohort study." The Lancet HIV (2022). https://www.sciencedirect.com/science/article/pii/S2352301822000339

[3] Esquivel-Valerio, Jorge Antonio, et al. "Adverse events of six COVID-19 vaccines in patients with autoimmune rheumatic diseases: a cross-sectional study." Rheumatology international 41.12 (2021): 2105-2108. https://link.springer.com/article/10.1007/s00296-021-05017-9

[4] Yuki, Emily FN, et al. "Impact of distinct therapies on antibody response to SARS‐CoV‐2 vaccine in systemic lupus erythematosus." Arthritis care & research (2021). https://onlinelibrary.wiley.com/doi/full/10.1002/acr.24824 

[5] Ciampi, Ethel, et al. "Safety and humoral response rate of inactivated and mRNA vaccines against SARS-CoV-2 in patients with Multiple Sclerosis." Multiple Sclerosis and Related Disorders 59 (2022): 103690. https://doi.org/10.1016/j.msard.2022.103690

[6] Pasoto, Sandra Gofinet, et al. "Inactivated SARS-CoV-2 vaccine in primary Sjögren’s syndrome: humoral response, safety, and effects on disease activity."  Clinical Rheumatology  (2022): 1-11. https://link.springer.com/article/10.1007/s10067-022-06134-x

[7] Xiong, Xi, et al. "Safety of inactivated and mRNA COVID-19 vaccination among patients treated for hypothyroidism: a population-based cohort study." Thyroid ja (2022).https://www.liebertpub.com/doi/abs/10.1089/thy.2021.0684

[8] Palacios, Ricardo, et al. "Efficacy and safety of a COVID-19 inactivated vaccine in healthcare professionals in Brazil: the PROFISCOV study." (2021). https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3822780

[9] Zhang, Yuemiao, et al. "Immunosuppression impaired the immunogenicity of inactivated SARS-CoV-2 vaccine in non-dialysis kidney disease patients." medRxiv (2022). https://doi.org/10.1101/2022.01.14.22269182

[10] Medina-Pestana, José, et al. "Clinical impact, reactogenicity, and immunogenicity after the first CoronaVac dose in kidney transplant recipients." Transplantation 106.1 (2022). https://journals.lww.com/transplantjournal/Fulltext/2022/01000/Clinical_Impact,_Reactogenicity,_and.40.aspx

[11] Medina-Pestana, José, et al. "Clinical impact, reactogenicity and immunogenicity after the first CoronaVac dose in dialysis patients: a Phase IV prospective study." Clinical Kidney Journal 14.12 (2021): 2612-2615. https://academic.oup.com/ckj/article/14/12/2612/6353597?login=false

[12] Yasin, Ayse Irem, et al. "Efficacy and safety profile of COVID-19 vaccine in cancer patients: a prospective, multicenter cohort study." Future Oncology 0 (2022). https://www.futuremedicine.com/doi/full/10.2217/fon-2021-1248

[13] Paixao, Enny S., et al. "CoronaVac vaccine is effective in preventing symptomatic and severe COVID-19 in pregnant women in Brazil: a test-negative case-control study." BMC medicine 20.1 (2022): 1-8. https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-022-02353-w

[14] Qiao, Yaping, et al. "Safety profile of COVID-19 vaccines in pregnant and postpartum women in brazil." medRxiv (2021). https://www.medrxiv.org/content/10.1101/2021.12.14.21267777v1

[15] https://www.who.int/publications/i/item/WHO-2019-nCoV-vaccines-SAGE_recommendation-Sinovac-CoronaVac-2021.1


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