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

968

项与 23价肺炎球菌多糖疫苗 (沃森生物) 相关的文献（医药）

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 ; Li, Zhi ; Chen, Juan ; 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.

2024-12-31·Expert Review of Vaccines

Adult indication 13-valent pneumococcal conjugate vaccine clinical development overview: formulation, safety, immunogenicity (dosing and sequence), coadministration, and efficacy

Review

作者: Fletcher, Mark A. ; Paradiso, Peter R. ; Daigle, Derek ; del Carmen Morales, Graciela ; Schmoele-Thoma, Beate ; Vojicic, Jelena

INTRODUCTIONThere was no 13-valent pneumococcal conjugate vaccine (PCV13) adult antibody concentration threshold regulatory criterion for licensure - unlike the pediatric indication; consequently, for the adult indication, PCV13 serotype-specific opsonophagocytic activity (OPA) geometric mean titer (GMT) values were immunobridged to the 23-valent plain polysaccharide vaccine (PPV23) to infer efficacy against invasive pneumococcal disease (IPD). Subsequently, a double-blind, randomized, controlled PCV13 efficacy trial (CAPiTA) was performed in community-living, older adults to confirm efficacy against vaccine-serotype IPD (VT-IPD) and establish efficacy against vaccine-serotype pneumococcal community-acquired pneumonia (VT-CAP).AREAS COVEREDThis article summarizes 31 publications from the PCV13 adult indication clinical development trials and other PCV13 clinical studies, organized by formulation, reactogenicity and safety, immunogenicity, coadministration, and clinical efficacy.EXPERT OPINIONPCV13 had a favorable safety profile with an OPA response generally greater than PPV23 irrespective of age and of previous pneumococcal vaccination. PCV13 primed for enhanced immune responses with subsequent PCV13 or PPV23 dosing. Conversely, PPV23 was shown to blunt the response to subsequent PCV13. CAPiTA demonstrated PCV13 efficacy for at least five years against both VT-IPD and VT-CAP. The PCV13 clinical development program provided fundamental insights into this vaccine's adult-specific immune responses and confirmed the advantages of conjugate over plain polysaccharide technology.

2024-09-01·Vaccine

Immunogenicity of a seasonal influenza and a pneumococcal polysaccharide vaccine in multiple sclerosis patients under disease modifying therapies: A single-center prospective study

Article

作者: Voumvourakis, Konstantinos ; Angelakis, Emmanouil ; Chondrogianni, Maria ; Mpizta, Giota ; Giannopoulos, Sotirios ; Marantos, Theodoros ; Kyriazopoulou, Evdoxia ; Kitsos, Dimitrios ; Tsiodras, Sotirios ; Papadopoulos, Antonios

BACKGROUNDImmunogenicity of influenza and pneumococcal vaccines varies and requires further elucidation in patients with multiple sclerosis (MS) under treatment with disease-modifying therapies (DMTs).METHODSAdult MS patients who consented with vaccination after standard-of-care consultation by their treating physicians were enrolled. All received a single dose of an inactivated quadrivalent influenza vaccine and of the 23-valent pneumococcal vaccine. A blood sample was collected before and after four weeks of vaccination for measurement of antibodies against Influenza A, B and S. pneumoniae. Patients were followed-up for adverse events and MS relapse for 12 months.RESULTSOne hundred and seventy-two patients (65.7 % female, mean age 42 ± 13 years old, mean MS duration 7.6 ± 7.2 years, 81.4 % under DMTs) were enrolled from November 2019 to March 2020. Antibody measurements were available for 151 patients. Seropositivity for anti-PPSV23 did not differ between baseline and at 4 weeks of follow-up (n = 56, 37.1 %). There was a significant increase of absolute antibody titers post-vaccination for both influenza A and B (p < 0.001). For Influenza A, seropositivity was evident for 57 (37.7 %) patients at 4 weeks compared to 19 (12.6 %) patients at baseline (p_McNemar < 0.001). For Influenza Β, 110 (72.8 %) seroconverted 4 weeks after vaccination compared to 12 (7.9 %) at baseline (p_McNemar < 0.001). Interferon and fumarate did not affect influenza seroconversion while rituximab was associated with lower titers. Mild local AEs (pain, edema) were observed in 23.8 %; no severe AE was reported. Thirty-four patients (19.8 %) had a relapse during the 12-month follow-up; none was attributed to the vaccination.CONCLUSIONSSeroconversion in MS patients on treatment was more frequent following influenza compared to PPSV23 vaccination. Rituximab had an effect on the height of the immune response. Better immunization coverage as well as future evaluation of the breadth of immune response elicited by immunization is necessary for these patients.

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)	齋遞構築齋齋範鹹蓋繭(顧醖糧窪糧製範鬱鬱鏇) = 鑰選憲獵獵衊糧選構築鹽鏇醖簾願壓壓鹽繭鹹 (顧齋網遞鬱觸顧網窪醖, 遞願製願鑰餘顧製蓋糧 ~ 齋壓憲壓窪窪積鏇襯夢) 更多	-	2019-01-31
				PPV23+ Fluvic HA syringe (Sequential Administration Group)	齋遞構築齋齋範鹹蓋繭(顧醖糧窪糧製範鬱鬱鏇) = 構積憲築製製觸鑰衊願鹽鏇醖簾願壓壓鹽繭鹹 (顧齋網遞鬱觸顧網窪醖, 鏇網願顧築積構衊積積 ~ 餘廠膚壓齋廠獵齋繭廠) 更多
ERS2017	N/A	-	130	23-valent pneumococcal polysaccharide vaccine	顧簾築鏇選繭鑰獵壓蓋(鹽範蓋遞鑰淵鏇膚鹽簾) = 鹽窪觸廠餘壓鹽艱製網蓋窪獵鹽淵顧鏇壓觸鏇 (糧獵憲範廠齋淵齋網齋 )	积极	2017-09-01
ERS2016	N/A	终末期肾脏病	545	23-valent pneumococcal polysaccharide vaccine	網顧獵顧淵遞餘廠齋構(積餘鏇鬱獵構獵製鹽選): 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