23价肺炎球菌多糖疫苗 (沃森生物)(Pneumococcal polysaccharide vaccine 23-valent (Walvax Biotechnology))

概要

基本信息

药物类型

预防性疫苗、多价疫苗

别名

23-valent pneumococcal polysaccharide vaccine、23-valent pneumococcal vaccine、Pneumococcal 23-valent polysaccharide vaccine

+ [2]

靶点-

作用机制

免疫刺激剂

治疗领域

感染

在研适应症

肺炎球菌感染

非在研适应症-

原研机构

玉溪沃森生物技术有限公司

在研机构

玉溪沃森生物技术有限公司

非在研机构-

最高研发阶段批准上市

首次获批日期

中国 (2017-03-22),

肺炎球菌感染

最高研发阶段(中国)批准上市

特殊审评-

登录后查看时间轴

关联

9

项与 23价肺炎球菌多糖疫苗 (沃森生物) 相关的临床试验

ChiCTR2300075573

/ Suspended临床3期IIT

A randomized, blinded, parallel controlled phase 3 clinical trial to evaluate the immunogenicity and safety of the 23-valent pneumococcal polysaccharide vaccine in healthy people aged 2 years and above

开始日期2023-09-09

申办/合作机构-

ChiCTR2200056827

/ Suspended临床4期IIT

Phase IV clinical trial of 23-valent pneumococcal polysaccharide vaccine

开始日期2022-02-08

申办/合作机构-

ChiCTR2100042000

/ Recruiting临床4期IIT

A phase IV clinical trial to evaluate the immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine revaccinations in the elderly

开始日期2021-01-04

申办/合作机构

中国疾病预防控制中心

100 项与 23价肺炎球菌多糖疫苗 (沃森生物) 相关的临床结果

登录后查看更多信息

100 项与 23价肺炎球菌多糖疫苗 (沃森生物) 相关的转化医学

登录后查看更多信息

100 项与 23价肺炎球菌多糖疫苗 (沃森生物) 相关的专利（医药）

登录后查看更多信息

1,009

项与 23价肺炎球菌多糖疫苗 (沃森生物) 相关的文献（医药）

2025-01-01·Vaccine

Effectiveness of 13-valent pneumococcal conjugate vaccine against vaccine-type invasive pneumococcal disease in older adults

Article

作者: Klein, Nicola P ; Timbol, Julius ; Suaya, Jose A ; Alexander-Parrish, Ronika ; Grant, Lindsay R ; Hansen, John ; Gessner, Bradford D ; Lewis, Ned ; Hsiao, Amber

BACKGROUNDIn 2014, the Advisory Committee on Immunization Practices recommended routine use of the 13-valent pneumococcal conjugate vaccine (PCV13) in adults age ≥ 65 years. Incidence of most PCV13-serotype cases declined, however serotype 3 cases have persisted. We estimated PCV13 vaccine effectiveness (VE) against PCV13-serotypes and serotype 3 invasive pneumococcal disease (IPD) among Kaiser Permanente Northern California (KPNC) adults.METHODSThis observational study included adults ≥65 years between September 1, 2014-December 31, 2020. We used active laboratory-based surveillance to identify and serotype all Streptococcus pneumoniae isolates obtained from normally-sterile sites. We estimated the odds ratio (OR) of vaccine-type IPD using conditional logistic regression stratified by age and calendar day, adjusting for sex, age, race, ethnicity, influenza vaccine receipt, 23-valent pneumococcal polysaccharide vaccine receipt since age 65, pneumonia risk factors, healthcare utilization, and KPNC service area. We estimated VE_Adjusted as (1-OR_Adjusted) × 100 %.RESULTSThere were 610,576 adults ≥65 years in the study population. By the end of the study period, PCV13 coverage was nearly 80 %. There were 307 IPD cases during the study period, of which 98 (31.9 %) were serotype 3. PCV13 was associated with a VE_Adjusted of 61.5 % (95 % CI: 36.2, 76.7; p < 0.001) against PCV13-serotype IPD and 46.3 % (95 % CI: -2.4, 77.9; p = 0.06) against serotype 3 IPD.CONCLUSIONSPCV13 vaccination protected adults ≥65 years against IPD due to PCV13 serotypes. Continued surveillance will be critical in the ≥65-year-old population to assess the impact of higher valent PCVs on IPD serotype distribution, including individual serotypes such as serotype 3.

2024-12-31·Human Vaccines & Immunotherapeutics

Preventive effects of 23-valent pneumococcal polysaccharide vaccine on community-acquired pneumonia hospitalization in older individuals in China: A case-control study

Article

作者: Wang, Lei ; Luan, Lin ; Wang, Huaqing ; Liu, Na

The effectiveness of 23-valent pneumococcal polysaccharide vaccine (PPSV23) against hospitalization risk due to all-cause community-acquired pneumonia (CAP) in older individuals in China is limited. A hospital-based case-control study was conducted on this issue in Suzhou City, Jiangsu Province, China. Cases were individuals who were newly diagnosed with CAP based on International Classification of diseases 10 (ICD10 code: J15.902, J15.903, J13.x00 × 001) from January 2023 to June 2023, while patients with other respiratory tract infections were the control group. The vaccination data of PPSV23 was obtained from Suzhou Center for Disease Control and Prevention. The results showed CAP group had a lower vaccination rate of PPSV23 within last 5 years than controls (3.27% vs. 4.81%). Both the severe CAP and non-severe CAP groups had lower vaccination rates of PPSV23 than controls. Logistic regression demonstrated that PPSV23 vaccination within 5 years in individuals aged ≥60 years prevented 26.7% hospitalization risks of all-cause CAP, with adjusted OR of 0.733 (95% CI = 0.605-0.887). PPSV23 vaccination could prevent 25.2% (adjusted OR = 0.748, 95% CI = 0.616-0.909) and 44.0% (adjusted OR = 0.560, 95% CI = 0.309-1.012) hospitalization risks due to non-severe CAP and severe CAP, respectively. PPSV23 vaccination is effective in reducing hospitalization risk due to CAP in older individuals.

2024-12-31·Expert Review of Vaccines

Persistence of antibody to 23-valent pneumococcal polysaccharide vaccine: a 5-year prospective follow-up cohort study

Article

作者: Guo, Xiang ; Zhang, Rui ; Lan, Fang ; Chen, Juan ; Li, Zhi ; Qiu, Jing ; Li, Juan ; Liang, Xiufang ; Huang, Zhuoying ; Ren, Jia ; Sun, Xiaodong ; Huang, Fang

BACKGROUNDPneumococcal vaccines are effective in preventing pneumococcal diseases in adults. The evaluation of the antibodies persistence to the 23-valent pneumococcal polysaccharide vaccine (PPV23) could provide evidence on PPV23 revaccination.RESEARCH DESIGN AND METHODSAdults aged ≥ 60 years were selected and vaccinated with PPV23 in Shanghai, and followed up for 5 years with blood samples collection of a 1-year interval. The geometric mean concentrations (GMC) of the IgG against 23 pneumococcal serotypes covered by PPV23 were detected using enzyme-linked immunosorbent assay. The antibodies to 23 pneumococcal serotypes among different groups was analyzed using statistical analysis.RESULTSOverall, 517 participants completed all six visits over a 5-year period (2013-2018). The GMC of 23 serotypes in adults aged ≥ 60 years decreased slowly after PPV23 vaccination compared to baseline pre-vaccination (P < 0.05), except serotype 3. Additionally, the multiplicative increase in the antibody concentration after PPV23 vaccination was greater, and the antibody levels of serotypes 1 and 6B were significantly higher at visit 5 than at visit 4 (P < 0.05).CONCLUSIONSThe pneumococcal antibodies in elderly after PPV23 vaccination could sustain high levels over long-term follow-up, which suggested that the interval of revaccination with PPV23 in elderly should be at least 5 years after the first vaccination.

100 项与 23价肺炎球菌多糖疫苗 (沃森生物) 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	J07AL01	-

研发状态

10 条最早获批的记录,

登录

后查看更多信息

适应症	国家/地区	公司	日期
肺炎球菌感染	中国	玉溪沃森生物技术有限公司	2017-03-22

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02592486 (CTgov)	临床4期	肺炎球菌性肺炎 \| 流感病毒感染	162	PPV23+ Fluvic HA syringe (Simultaneous Administration Group)	鏇艱鬱襯窪積艱鹽顧膚(醖獵艱範壓醖鏇蓋構憲) = 顧艱蓋齋顧積鏇窪鏇簾觸淵繭築網淵蓋築鏇窪 (壓艱鑰蓋鏇鏇鬱鬱襯繭, 獵簾衊壓鑰遞餘觸衊製 ~ 網淵鬱願淵範蓋襯壓艱) 更多	-	2019-01-31
				PPV23+ Fluvic HA syringe (Sequential Administration Group)	鏇艱鬱襯窪積艱鹽顧膚(醖獵艱範壓醖鏇蓋構憲) = 鹹顧廠製鏇壓醖憲鏇積觸淵繭築網淵蓋築鏇窪 (壓艱鑰蓋鏇鏇鬱鬱襯繭, 積鏇糧鬱齋網願願壓觸 ~ 餘夢製積鹽鏇遞艱齋蓋) 更多
ERS2017	N/A	-	130	23-valent pneumococcal polysaccharide vaccine	糧醖繭夢鏇鏇壓艱築憲(淵糧製積觸網窪遞膚鏇) = 餘鬱顧簾繭範網選鏇繭獵窪壓壓積製鑰襯壓蓋 (選鹹窪憲觸糧廠蓋壓鏇 )	积极	2017-09-01
ERS2016	N/A	终末期肾脏病	545	23-valent pneumococcal polysaccharide vaccine	夢繭憲鏇遞衊獵醖選餘(繭顧膚窪繭鑰獵憲範齋): OR = 0.61 (95% CI, 0.343 ~ 1.085), P-Value = 0.092 更多	不佳	2016-09-01
				23-valent pneumococcal polysaccharide vaccine