13价肺炎球菌结合疫苗(北京科兴中维)(13-valent pneumococcal conjugate vaccine(Sinovac Life Sciences))

概要

基本信息

药物类型

预防性疫苗、多价疫苗、结合疫苗

别名-

靶点-

作用方式

刺激剂

作用机制

免疫刺激剂

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

非在研机构

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)临床3期

特殊审评-

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关联

2

项与 13价肺炎球菌结合疫苗(北京科兴中维) 相关的临床试验

CTR20160352

/ Suspended临床1期

2岁以上人群开放性试验及婴儿中的随机盲法对照试验，评价13价肺炎球菌结合疫苗安全性和免疫原性的Ⅰ期临床试验

评价北京科兴生物制品有限公司研制的13价肺炎球菌结合疫苗应用于18-59岁成人、2-11岁儿童、≥60岁老人和42-77天龄婴儿的安全性和免疫原性。

开始日期-

申办/合作机构

北京科兴生物制品有限公司

[+1]

NCT06617715

/ Recruiting临床3期

A Phase Ⅲ Clinical Study to Evaluate the Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (PCV13) in Healthy Infants

A Phase Ⅲ clinical trial of 13-valent pneumococcal conjugate vaccine (PCV13) developed by Sinovac Life Science Co., Ltd will be conducted in pediatric population aged 2 months (minimum 6 weeks)-5 years (before 6th birthday). The objective of the study is to evaluate the immunogenicity and safety of Sinovac PCV13.

开始日期2024-10-23

申办/合作机构

北京科兴中维生物技术有限公司

100 项与 13价肺炎球菌结合疫苗(北京科兴中维) 相关的临床结果

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100 项与 13价肺炎球菌结合疫苗(北京科兴中维) 相关的转化医学

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100 项与 13价肺炎球菌结合疫苗(北京科兴中维) 相关的专利（医药）

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620

项与 13价肺炎球菌结合疫苗(北京科兴中维) 相关的文献（医药）

2025-12-31·Expert Review of Vaccines

The impact of non-pharmacological interventions on nasopharyngeal Staphylococcus aureus , Streptococcus pneumoniae , Moraxella catarrhalis , Haemophilus influenzae carriage and the change of pneumococcal vaccination in healthy children under 5 years old in Beijing, China

Article

作者: Yao, Kaihu ; Shi, Wei ; Du, Qianqian ; Liu, Xijie ; Meng, Qinghong ; Liu, Zhaoqiu ; Zheng, Dongyi

BACKGROUNDWe analyzed the impact of non-pharmacological interventions (NPIs) andPCV13 inoculation on nasopharyngeal (NP) carriage of Staphylococcus aureus(Sa), Streptococcus pneumoniae (Sp), Moraxella catarrhalis (Mc)and Haemophilus influenzae (Hi) in healthy children under 5 years old inBeijing, China.RESEARCH DESIGN AND METHODSNP swabs were taken from healthy childrenseeking routine well-child care at the pediatricpreventive health clinic. NP swabs were frozenin Tryptic Soy Broth (TSB) medium and stored at -80°C, and bacterial was detectedby culture.RESULTSFrom December 2019 to November 2021, 1939children were enrolled, among whom 278 (14.3%) were found to carry Sa isolates,115 (5.9%) Sp, 39 (2.0%) Mc, and 6 (0.3%) Hi. The carriage of Sa was highest in infants under 6 months, negativelycorrelated with Sp and Mc. The Sa carriage rate in infants below six monthsof age rose from 26.7% in pre-NPIs to 32.7% in post-NPIs early. The13-valent pneumococcal conjugate vaccine (PCV13) uptake rose from 42.3% in December2019 to 62.3% by October 2021.CONCLUSIONSThe broad applicationof NPIs caused a decline in Sp and Mc carriage among children under five yearsold, accompanied by an elevation in theSa carriage rate among infants.

2025-02-01·Pediatric Infectious Disease Journal

Infant Responses to Primary Immunization Following Vaccination in Pregnancy With Varying Doses of Recombinant Acellular Pertussis Vaccine Alone or Combined With Tetanus-Diphtheria

Article

作者: Chokephaibulkit, Kulkanya ; Pham, Hong Thai ; Kerdsomboon, Chawanee ; Phongsamart, Wanatpreeya ; Fortuna, Librada ; Puthanakit, Thanyawee ; Wittawatmongkol, Orasri ; Chaithongwongwatthana, Surasith ; Tang, Yuxiao ; Bhat, Niranjan ; Innis, Bruce L. ; Mansouri, Souad ; Anugulruengkitt, Suvaporn ; Rungmaitree, Supattra ; Yuwaree, Vilasinee

Background:Vaccination in pregnancy with recombinant pertussis vaccine results in similar or higher antibody levels in infants compared with chemically detoxified acellular pertussis vaccine (Tdapchem). We evaluated antibody responses to primary childhood vaccination in infants born to mothers vaccinated in pregnancy with recombinant pertussis vaccine containing 1, 2 or 5 µg genetically detoxified pertussis toxin (ap1gen, Tdap1gen, Tdap2gen or TdaP5gen) or Tdapchem.Methods:Infants (393) received diphtheria-tetanus-whole cell pertussis (DTwP) at 2, 4 and 6 months (3+0) and 13-valent pneumococcal conjugate vaccine (PCV13) at 2, 4 and 12 months of age (2+1). Serum IgG levels against pertussis toxoid (PT), filamentous hemagglutinin (FHA), diphtheria toxoid (DT), tetanus toxoid (TT), PCV13 serotypes and PT-neutralizing antibody (PT-Nab) titers were assessed. PT-IgG ≥10 IU was used as a cutoff for potential protection in infants.Results:PT-IgG geometric mean concentrations (GMC) were ≥10 IU/mL at 5 and 7 months of age but waned below 10 IU/mL at 13 months in all groups. FHA-IgG GMCs and PT-Nab geometric mean titers were also below 10 IU/mL in all groups at 13 months of age. TT-IgG and DT-IgG seroprotection rates (≥0.1 IU/mL) ranged from 97.1% to 100% at 7 and 13 months. Postbooster PCV13-serotype-specific seroprotection rates (IgG ≥ 0.35 µg/mL) ranged between 87% and 100%. Antibody responses were comparable between groups after DTwP priming (7 months) and PCV13 priming (5 months) and booster vaccination (13 months).Conclusions:Childhood vaccine responses are comparable after mothers receive genetically or chemically detoxified acellular pertussis vaccines in pregnancy.

2025-01-01·Vaccine

Cost-effectiveness of 15-valent or 20-valent pneumococcal conjugate vaccine for U.S. adults aged 65 years and older and adults 19 years and older with underlying conditions

Article

作者: Leidner, Andrew J ; Kobayashi, Miwako ; Pilishvili, Tamara ; Stoecker, Charles ; Rosenthal, Melissa ; Cho, Bo-Hyun

BACKGROUNDIn June 2021, the Advisory Committee on Immunization Practices (ACIP) recommended use of either 20-valent pneumococcal conjugate vaccine (PCV20) alone or 15-valent pneumococcal conjugate vaccine (PCV15) in series with 23-valent pneumococcal polysaccharide vaccine (PPSV23) for all PCV-unvaccinated adults aged ≥65 years (age-based) and for adults aged 19-64 years with conditions that increase the risk for pneumococcal disease (risk-based). This recommendation replaced a previous recommendation for PPSV23 with or without 13-valent pneumococcal conjugate vaccine (PCV13) for these groups.OBJECTIVEWe conducted a cost-effectiveness analysis of age-based and risk-based use of either PCV15 in series with PPSV23 or PCV20 alone when compared to previous recommendations.METHODSWe utilized probabilistic cohort models of all 65-year-olds (age-based) and 19-year-olds (risk-based through age 64 years and age-based at age 65 years). A spreadsheet-based Monte Carlo simulation software was used to estimate immunization costs, medical costs, non-medical costs, and overall disease burden under different vaccine strategies. The model tracked inpatient invasive pneumococcal disease (IPD) and non-bacteremic pneumonia (NBP) in inpatient and outpatient settings. One-way sensitivity analyses incorporated indirect effects of prospective pediatric vaccination with PCV15 and PCV20 on adult IPD and NBP incidence. Costs were reported in 2021 US dollars. All future costs and outcomes were discounted at 3 % per year.RESULTSAge-based use of either PCV20 alone or PCV15 in series with PPSV23 at age 65 years were both shown to be cost-saving (improved health outcomes and saved costs). Combined cost-effectiveness of risk-based (19-64 years) plus age-based (65 years) (risk-and-age-based) use of PCV20 alone was cost-saving, whereas use of PCV15 in series with PPSV23 increased quality-adjusted life years (QALYs) but cost $412,111 (95 % CI: 270,295, 694,869) per QALY gained.CONCLUSIONIn U.S. adults, replacing the previous recommendations with PCV20 alone or PCV15 in series with PPSV23 improved health outcomes. Except for risk-and-age-based use of PCV15 in series with PPSV23 that resulted in increased cost per QALY gained, the interventions also reduced costs.

100 项与 13价肺炎球菌结合疫苗(北京科兴中维) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
肺炎球菌感染	临床3期	中国	北京科兴中维生物技术有限公司	2024-10-23
肺炎	临床1期	中国	北京科兴中维生物技术有限公司	2018-04-10
肺炎	临床1期	中国	北京科兴生物制品有限公司	2018-04-10