肺炎球菌7价结合疫苗(Pfizer Inc.)(Pneumococcal 7-valent conjugate vaccine(Pfizer Inc.)) - 在研适应症：肺炎球菌感染，侵袭性肺炎球菌病，中耳炎_专利_临床

概要

基本信息

药物类型

预防性疫苗、结合疫苗

别名

Pneumococcal 7-valent CRM197 vaccine conjugate、pneumococcal polysaccharide serotype 4/pneumococcal polysaccharide serotype 6B/pneumococcal polysaccharide serotype 9V/pneumococcal polysaccharide serotype 14/ pneumococcal oligosaccharide serotype 18C/pneumococcal polysaccharide serotype 19F/pneumococcal polysaccharide serotype 23F、pneumococcal saccharide conjugated vaccine, adsorbed

+ [7]

靶点-

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

Wyeth Pharmaceuticals LLC

Pfizer Inc.

非在研机构

Pfizer Ltd.Novartis Vaccines & Diagnostics SLWyeth AB

最高研发阶段批准上市

首次获批日期

美国 (2000-02-17),

侵袭性肺炎球菌病中耳炎

最高研发阶段(中国)-

特殊审评-

登录后查看首次获批时间轴

关联

56

项与肺炎球菌7价结合疫苗(Pfizer Inc.) 相关的临床试验

NCT04401488 / Unknown statusN/A

Paediatric Post Pneumococcal Conjugate Vaccine Nasopharyngeal Carriage Study

The investigators intend to investigate the carriage of pneumococci and other respiratory microbes since the introduction of pneumococcal conjugate vaccines (Prevenar 7 and Prevenar 13). The principal aim is to gain a collection of samples that can be used to help investigate any changes that might occur in the epidemiology of microbes that are carried in the upper respiratory tract and which may cause respiratory disease, sepsis or meningitis after the introduction of Prevenar.
Nasopharyngeal and nasal swabs will be taken from up to 2,000 children aged 4 years and under in each year of the study. Swabs will be processed using traditional microbiology and molecular diagnostic techniques and isolated microbes such as S. pneumoniae further characterised using molecular methods. The investigators will also ask parents to complete a short questionnaire requesting: basic demographic data; vaccine history; recent illness; overseas travel and antibiotic usage.
The study will contribute to the success of the introduction of pneumococcal conjugate vaccines and will play a central role in maintaining confidence. The study will also help provide information for future vaccine policy as further vaccines are developed against microbes which cause respiratory disease, sepsis and meningitis.

开始日期2014-10-01

申办/合作机构

University Hospital Southampton NHS Foundation Trust

[+1]

NCT01307449 / CompletedN/AIIT

Systems Biology of 23 Valent Pneumococcal Polysaccharide Vaccine (PNEUMOVAX®23) and 13-valent Pneumococcal Conjugate Vaccine (PREVNAR 13®)

Vaccination is the most effective way of preventing infectious diseases. Despite the success of vaccines in general, vaccines induce diminished antibody responses and lower protection in the elderly in particular. This could be explained by a defect in the early responses of an ageing immune system. A better understanding of the basic immunological mechanisms that mediate vaccine efficacy is incomplete. Such information is critical and could greatly decrease both the cost and the time to new vaccine development particularly for the geriatric population.
In this trial, the investigators will study the immunologic differences of two FDA approved licensed pneumococcal vaccines between a younger and an older group. Twenty two healthy volunteers between the age of 25-40 and sixty six healthy volunteers between the ages of 60-89 will be enrolled in the study. Each participant in the study will be given one pneumococcal shot. Blood work will be obtained prior to vaccination, one day, three days, seven days, fourteen days, as well as one month and six months after vaccination. Throughout the duration of the study, the participants will be monitored for safety.

开始日期2014-04-01

申办/合作机构

Emory University

[+1]

NCT02133469 / CompletedN/AIIT

Effectiveness of PCV7 in the Prevention of Nasopharyngeal Carriage of Vaccine Serotype (VT) Streptococcus Pneumoniae in 2 to 5 Years Old Healthy Chinese Children.

A parallel-group, randomized, open-label study will be performed in subjects receiving PCV7 and subjects receiving controlled vaccine Hib vaccine, to claim the efficacy of PCV7 in the prevention of NP carriage of vaccine-serotype S. pneumoniae (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F combined) in 2 to 5 years old healthy Chinese children.

开始日期2012-06-01

申办/合作机构

北京市卫生局

[+1]

100 项与肺炎球菌7价结合疫苗(Pfizer Inc.) 相关的临床结果

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100 项与肺炎球菌7价结合疫苗(Pfizer Inc.) 相关的转化医学

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100 项与肺炎球菌7价结合疫苗(Pfizer Inc.) 相关的专利（医药）

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2,150

项与肺炎球菌7价结合疫苗(Pfizer Inc.) 相关的文献（医药）

2024-12-31·Expert review of vaccines

Predicted serotype-specific effectiveness of pneumococcal conjugate vaccines V114 and PCV20 against invasive pneumococcal disease in children

Article

作者: Weiss, Thomas ; Weaver, Jessica ; Yee, Ka Lai ; Banniettis, Natalie ; Sachs, Jeffrey R ; Ryman, Josiah

BACKGROUND:

Next-generation, higher-valency pneumococcal conjugate vaccines (PCVs), 15-valent PCV V114 and 20-valent PCV (PCV20), have been assessed by comparing their immune responses across serotypes shared with the 13-valent PCV (PCV13). Without efficacy or real-world vaccine effectiveness (VE) it becomes important to relate IgG titers to VE to aid in the interpretation of the immune response elicited by V114 and PCV20.

METHODS:

We estimated the protective antibody concentrations for each serotype in 7-valent PCV (PCV7) and PCV13 which were then used to predict the serotype-specific VE for each PCV7 and PCV13 non PCV7 serotype present in V114 and PCV20.

RESULTS:

The predicted effectiveness of V114 was comparable to PCV7 and PCV13 for 11 of the 13 shared serotypes (1, 4, 5, 6B, 7F, 9 V, 14, 18C, 19A, 19F, and 23F), with improved effectiveness against serotype 3 and decreased effectiveness against serotype 6A. PCV20 had predicted effectiveness comparable to PCV7 and PCV13 for 7 of the 13 shared serotypes (5, 6A, 7F, 9 V, 18C, 19F, and 23F), with decreased effectiveness against the remaining serotypes (1, 3, 4, 6B, 14, and 19A).

CONCLUSIONS:

Prediction of serotype-specific VE values suggests that V114 retains greater effectiveness than PCV20 toward most serotypes present in PCV7 and PCV13.

2024-01-01·Vaccine

Cost-effectiveness of 20-valent pneumococcal conjugate vaccine in US infants

Article

作者: Snow, Vincenza ; Chilson, Erica ; Farkouh, Raymond A ; Dillon-Murphy, Desmond ; Rozenbaum, Mark H ; Chapman, Ruth ; Perdrizet, Johnna ; Arguedas, Adriano ; Cane, Alejandro ; Tort, Maria J ; Huang, Liping ; Hayford, Kyla

BACKGROUND:

As of June 2023, two pneumococcal conjugate vaccines, 20- (PCV20) and 15- (PCV15) valent formulations, are recommended for US infants under a 3 + 1 schedule. This study evaluated the health and economic impact of vaccinating US infants with a new expanded valency PCV20 formulation.

METHODS:

A population-based, multi cohort, decision-analytic Markov model was developed to estimate the public health impact and cost-effectiveness of PCV20 from both societal and healthcare system perspectives over 10 years. Epidemiological data were based on published studies and unpublished Active Bacterial Core Surveillance System (ABCs) data. Vaccine effectiveness was based on PCV13 effectiveness and PCV7 efficacy studies. Indirect impact was based on observational studies. Costs and disutilities were based on published data. PCV20 was compared to both PCV13 and PCV15 in separate scenarios.

RESULTS:

Replacing PCV13 with PCV20 in infants has the potential to avert over 55,000 invasive pneumococcal disease (IPD) cases, 2.5 million pneumonia cases, 5.4 million otitis media (OM) cases, and 19,000 deaths across all ages over a 10-year time horizon, corresponding to net gains of 515,000 life years and 271,000 QALYs. Acquisition costs of PCV20 were offset by monetary savings from averted cases resulting in net savings of $20.6 billion. The same trend was observed when comparing PCV20 versus PCV15, with a net gain of 146,000 QALYs and $9.9 billion in net savings. A large proportion of the avoided costs and cases were attributable to indirect effects in unvaccinated adults and elderly. From a health-care perspective, PCV20 was also the dominant strategy compared to both PCV13 and PCV15.

CONCLUSIONS:

Infant vaccination with PCV20 is estimated to further reduce pneumococcal disease and associated healthcare system and societal costs compared to both PCV13 and PCV15.

2024-02-01·Vaccine

Effectiveness of 13-valent pneumococcal conjugate vaccine against vaccine-serotype community acquired pneumococcal diseases among children in China: A test-negative case-control study

Article

作者: Lijun, You ; Jianmei, Tian ; Benfeng, Zheng ; Lin, Luan ; Yudan, L I ; Jun, Zhang ; Qinghui, Chen ; Genming, Zhao ; Jiaming, Shen ; Biying, Wang ; Xiaofei, Liu ; Youyi, Zhang ; Xuejun, Shao ; Tao, Zhang

BACKGROUND:

In 2016, China licensed 13-valent pneumococcal conjugate vaccine (PCV13) based on a study that demonstrated its immunogenicity is non-inferior to PCV7. However, the real-world effectiveness of PCV13 against vaccine-serotype pneumococcal diseases in China has limited evidence.

METHODS:

A test-negative case-control study was conducted among children under 5 years old admitted to the Children's Hospital of Soochow University (SCH) with respiratory tract infections from January 2018 to December 2020. Cases were defined as children from whom the isolates were tested positive for Streptococcus pneumoniae (S. pneumoniae) with serotypes included in PCV13. Two control groups were included, one represented children with isolates positive for S. pneumoniae of non-PCV13 serotypes and the other comprised children who tested negative for S. pneumoniae. The S. pneumoniae-negative controls were selected by matching them to the cases based on gender, age and admission date in a 1:1 ratio. Vaccine effectiveness (VE) was calculated using a logistic regression model as (1- adjusted odds ratio) * 100 %.

RESULTS:

A total of 2371 pneumococcal isolates were included in the analysis, of which 75.0 % (1779/2371) were covered by PCV13 serotypes. Consequently, these 1779 children were classified as cases, and 592 children were designated as non-PCV13 serotype controls. Another 1779 children were correspondingly recruited as S. pneumoniae-negative controls. Overall, 40 cases (2.3 %) and 148 controls (6.2 %) had received vaccination. The overall VE in the PCV13/non-PCV13 serotypes case-control study was 50.0 % (95 % CI: 15.0, 70.7), which was lower than the VE of 74.4 % (95 % CI: 60.7, 83.3) in the matched PCV13/S. pneumoniae-negative case-control study. VE was higher for ≥ 2 or ≥ 3 doses of vaccination compared to ≥ 1 dose. VE against specific PCV13 serotypes (6B, 6A and 19F) was higher than for other serotypes.

CONCLUSIONS:

PCV13 vaccination demonstrates effectiveness against vaccine-serotype pneumococcal diseases in children, particularly for serotypes 6B, 6A and 19F.

101

项与肺炎球菌7价结合疫苗(Pfizer Inc.) 相关的新闻（医药）

2024-09-06

·生物制品圈

Vaxcyte在与辉瑞的31价肺炎球菌结合疫苗(PCV)竞赛中取得“惊人”胜利后股价飙升

Vaxcyte公布了其31价肺炎球菌疫苗候选物的1/2期数据，分析师称之为“惊人”，如果这些数据能在大型关键研究中复制，可能会对辉瑞的Prevnar 20构成严重威胁。 Vaxcyte为其VAX-31在50岁及以上成人中与Prevnar 20头对头的1/2期数据是“非凡的”，并暗示了“肺炎球菌结合疫苗类别杀手级产品”，Leerink Partners分析师在周二的报告中表示。 Leerink分析师表示：“我们认为这些数据支持VAX-31有可能在2030年+预期超过100亿美元的肺炎球菌结合疫苗市场中获得大部分市场份额。” 由于这一积极的读数，Mizuho分析师称之为“最佳情况”，Vaxcyte的股价在周二上午的发布时间跳升了约44%。由于在与Prevnar的比较中取得胜利的数据，Vaxcyte的股价在周二上午跳升了约44%。（Yulia Sutyagina/iStock/Getty Images Plus） Vaxcyte的联合创始人兼首席执行官Grant Pickering在周二的投资者电话会议上表示：“今天，我们正在为Vaxcyte开启新篇章，因为我们从新兴公司转变为潜在的强大力量。” 分析师兴奋的一个关键点是，VAX-31在中剂量和高剂量下显示出的抗体免疫反应（通过吞噬细胞活性测定法测量）要么匹配要么超过了Prevnar 20在两种疫苗共有的20个血清型上的免疫反应。对于中剂量，VAX-31在20个血清型中的13个血清型与Prevnar 20相比具有大于1的几何平均比（GMR），并在五个血清型上实现了统计上更高的免疫反应。对于高剂量，18个血清型具有高于1的GMR，7个血清型被认为在统计上高于Prevnar 20。 Leerink分析师总结称，对于共有的血清型，VAX-31的免疫反应平均比高剂量高出25%，中剂量高出10%。 VAX-31在所有20个血清型上满足非劣效性，让分析师感到惊讶，因为为了处理疫苗额外免疫原所需的额外载体蛋白预计将减少某些血清型的抗体反应。这是为了实现更广泛的血清型覆盖而做出的权衡。正如Leerink分析师所指出的，许多分析师之前认为VAX-31的高剂量将无法在20个共有血清型中的大约三个上满足非劣效性。 Vaxcyte能够包含31个血清型要归功于其专有的节省载体技术。该平台允许以更精确的方式将多糖与载体蛋白结合，同时保留暴露关键T细胞表位，根据公司的说法。除了辉瑞疫苗涵盖的所有血清型外，VAX-31还包含11个额外的血清型。对于VAX-31独有的血清型，Vaxcyte疫苗在所有三个测试剂量上都优于辉瑞的选择。通过覆盖31个血清型，VAX-31旨在预防在美国50岁及以上成人中超过95%的侵袭性肺炎球菌疾病。相比之下，Prevnar 20可以覆盖该年龄组52%的疾病负担，默克公司的Capvaxive新批准的目标是84%。鉴于这些积极的数据显示，Mizuho分析师建议VAX-31有潜力取代Prevnar 20甚至Capvaxive，尽管团队警告说，当局可能会通过允许多个参与者来保留系统中的某些冗余。VAX-31还比Capvaxive有优势，因为它包含了特别受到疾病控制和预防中心免疫实践咨询委员会在6月会议期间关注的血清型4，Leerink分析师在早先的报告中指出。默克疫苗不包含血清型4，这被认为是对健康公平很重要的，因为它最常影响某些代表性不足的人群。 Vaxcyte还面临着为VAX-31选择正确的3期剂量的愉快问题。随着生物技术公司权衡其选择，Vaxcyte仍在分析更多数据，包括预先指定的年龄队列分析，首席执行官Pickering在周二的电话会议上表示。 Pickering说：“随着我们走向决策，我们将审视数据的整体情况。显然，使用较少的材料来驱动免疫反应可以创造效率。但只要我们没有看到任何安全差异，创造更高的免疫反应也是有吸引力的。” 在与FDA会面后，公司计划在2025年中开始关键的3期试验，预计2026年将获得顶线结果。除了VAX-31，Vaxcyte还在开发24价候选物VAX-24，公司预计将在2025年第一季度报告来自2期婴儿研究的顶线安全性和免疫原性数据。VAX-31的另一项2期婴儿试验计划于明年初开始。参考资料：https://www.fiercebiotech.com/biotech/vaxcytes-stunning-31-valent-pneumococcal-vaccine-win-against-pfizers-prevnar-20-has 识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

疫苗

2024-09-06

·BioPharmaDive

Obesity drug startup raises $67M; Vor’s ‘shielded transplant’ shows promise

Today, a brief rundown of news from OrsoBio, as well as updates from Boehringer Ingelheim, Novartis and Vaxcyte that you may have missed.OrsoBio, an obesity-focused startup backed by Eli Lilly, has raised $67 million in a Series B funding round, the company announced Friday. The cash will help advance a portfolio of weight loss medicines aimed at different drug targets than the GLP-1 therapies sold by Lilly and Novo Nordisk. Two of OrsoBios drugs are in Phase 2 testing for diabetes and metabolic dysfunction-associated steatohepatitis, while a third, oral medication should begin mid-stage testing “in the coming months,“ the company said in a statement. Ben FidlerA transplant of CRISPR-edited stem cells successfully engrafted in all 18 people with acute myeloid leukemia given the experimental therapy, called trem-cel and developed by Vor Bio. Notably, the gene edits appeared to shield against on-target toxicity from subsequent dosing with the drug Mylotarg in 10 of the study participants. Mylotarg, an old drug for AML, targets a protein called CD33 thats overexpressed in the cancer. Vors transplanted cells are edited to remove CD33 so theyre protected from Mylotarg-related friendly fire. Shares in Vor climbed by as much as 40% Friday on the news. Ned PagliaruloBoehringer Ingelheim plans to advance an experimental eye drug into mid-stage testing early next year, after the antibody fragment proved safe in a Phase 1 trial. The drug, which Boehringer developed with technology it licensed from Swiss biotechnology company CDR-Life, is designed to treat geographic atrophy, a leading cause of blindness that until recently had no treatment options. Boehringer said the drugs design may allow it to get to the root of disease pathology and therefore believes it could achieve unprecedented efficacy. Ned PagliaruloNovartis has licensed a capsid from Voyager Therapeutics for use building a gene therapy that can treat a rare neurological disease. Capsids can take a number of forms, but are used to shuttle genetic material to the right cells. Voyagers are designed to get into the brain, a notoriously hard region of the body to reach. The companies have been working together since 2022, and expanded their collaboration this past January. As a result of the license, Novartis will pay Voyager $15 million. Ned PagliaruloVaccine developer Vaxcyte said Wednesday it raised approximately $1.3 billion from investors following positive early data for its experimental pneumococcal conjugate shot. The drugmakers market value jumped to more than $12 billion Tuesday after the company disclosed the data, which analysts viewed as competitive to Pfizers market-leading Prevnar vaccine. Vaxcyte said it is selling nearly 10.2 million shares of common stock at $103 per share, as well as pre-funded warrants to purchase about 2.4 million shares of common stock. The secondary offering is set to close Friday. Delilah Alvarado '

疫苗基因疗法临床2期临床1期

2024-09-05

·同写意

百亿美金的胜利，疫苗新贵崛起启示录

过去几年，国产创新疫苗企业讲故事的时候，最喜欢提的一个概念是：国产替代。即，国内疫苗品种与海外疫苗品种，存在代际差距。在这一逻辑下，只要企业在特定的品种领域，跑得足够快，也将收获足够的想象空间。这句话乍听起来没什么问题，但忽略了一个重要前提：新旧王的权力交接，往往来自对产品的解构与重塑。如果达不到这一点，红利期，可能也只是非常短暂的。也正因此，虽然不少疫苗企业，多个潜力大单品的进展越来越多，但市值、估值却越来越低。相比之下，海外疫苗企业Vaxcyte，走出了不一样的路径。截至目前，其进入临床的疫苗管线，只有VAX-24、VAX-31两款肺炎疫苗。进度最快的VAX-21，还只处于临床2期阶段。但这并不妨碍华尔街对Vaxcyte的看好。9月3日，随着VAX-31积极的临床数据公布，Vaxcyte股价大涨36.39%，市值已经超过120亿美金；自2022年至今，Vaxcyte股价逆势上涨超320%。 Vaxcyte做对了什么？细究起来，Vaxcyte的成功哲学并不复杂：不要追逐，而要跟着进化。 1 卷到31价新冠疫苗之前，辉瑞的13价肺炎疫苗是全球“疫苗之王”，2018年全球销售额接近60亿美元，远超第二名9价HPV疫苗（31.5亿美元）。没人愿意错过这么大的市场。而就在国内企业还在卷13价肺炎疫苗（PCV13）的时候，Vaxcyte卷向了价型的升级。VAX-24是覆盖24个病毒类型的疫苗，而VAX-31则卷到了31个类型。固然，13价肺炎疫苗已经给肺炎的预防，带来了划时代的改变。但是，PCV13普及程度大幅提升的同时，也带来了新的烦恼：病毒类型的替换。自引入PCV13以来，疫苗中包含的血清型引起的疾病发病率有所下降。然而，有一种现象称为血清型替换，即在广泛接种疫苗后，血清型覆盖之外的增量毒株，将会成为肺炎的罪魁祸首。现在的美国市场，就遭遇了这个困境。根据2020年发布的数据，2017年儿童和成人IPD（肺炎球菌性肺炎）发病率的71%以上是由PCV13涵盖的13种菌株以外的菌株引起的。很显然，我们需要更广谱的PCV来保持对历史致病菌株的保护，同时扩大覆盖范围以解决当前流行的和新出现的菌株。这也是肺炎疫苗继续迭代的逻辑。默沙东的PCV15、辉瑞的PCV20，都是在此逻辑下面世的。尽管取得了这些进展，但这些第三代疫苗的覆盖率仅解决了流行疾病的一半。对此，Vaxcyte希望做得更多。VAX-24和VAX-31分别将覆盖率提高到目前在美国成年人群中传播的疾病的约63%和95%。而这，也支撑起市场对Vaxcyte的无限期待。 2 战胜辉瑞的预期 “VAX-31的表现令人震撼”。在发布1/2期数据后，有海外分析师这样评价。确实，不管是免疫原性还是安全性，看起来VAX-31都值得期待。免疫原性方面，不管是高剂量还是低剂量组，VAX-31的战斗力都不弱于辉瑞的20价肺炎疫苗，VAX-31 在所有20种血清型上都达到非劣效性，部分血清型甚至更强。具体来看：在高剂量下，所有20种血清型均符合OPA反应非劣效性标准，20种血清型中有18种的GMR大于1.0,7种血清型实现了统计学上更高的免疫反应。在中等剂量下，所有20种血清型都符合OPA反应非劣效性标准，20种血清型中有13种的GMR大于1.0,5种血清型实现了统计学上更高的免疫反应。在低剂量下，20种血清型中有18种符合OPA反应非劣效性标准，20种血清型中有8种的GMR大于1.0，三种血清型实现了统计学上更高的免疫反应。平均来看，VAX-31高剂量组对共享血清型的免疫反应高25%，中剂量高10%。而对于VAX-31特有的所有11种增量血清型，所有三种剂量都符合优效性标准。所以，在效果这一层面，VAX-31的表现绝对是超出预期的。并且，在安全性和耐受性方面，VAX-31都相对良好。根据完整的六个月安全性数据， VAX-31在研究的所有剂量下都显示出与 PCV20 相似的安全性特征。鉴于积极的数据，瑞穗分析师表示， VAX-31有可能取代辉瑞的Prevnar 20，甚至可能取代默沙东今年刚获批上市的21价肺炎球菌结合疫苗Capvaxive。Prevnar 20可以覆盖该年龄组52%的病毒类型，而Capvaxive的目标则是84%。考虑到肺炎疫苗的市场预期超过百亿美元，因此市场对VAX-31充满期待。尽管创新药遭遇史上最强寒冬，但2022年至今，Vaxcyte股价涨幅超过320%，最新市值超过120亿美元，约854亿人民币。虽然VAX-31距离成功，还有很长的路要走。Vaxcyte预计，将在2025年中前启动VAX-31所有剂量组的三期临床，并于2026年完成。 3 用壁垒制胜市场的高预期也可以理解，VAX-31如果能够成功，可能会为Vaxcyte带来极高的竞争壁垒。毕竟，更好的肺炎疫苗，不是一个简单的堆价型的工作。当前的肺炎疫苗技术路线，存在很大的局限性。一方面，传统的偶联方法无法控制多糖在蛋白质载体上的偶联位置。例如，所有版本的沛儿疫苗中使用的蛋白质载体都是CRM197，这是一种白喉毒素，通过单点突变使其无毒。CRM197蛋白含有39个赖氨酸，其中约20%与相关的T细胞表位相邻。传统的偶联化学随机地将多糖附着在蛋白质载体上的众多赖氨酸上。当多糖与T细胞表位共存的赖氨酸残基共价结合到蛋白质载体上时，它会阻断T细胞表位对免疫系统的呈递，从而阻止T细胞反应的诱导。这些关键表位的掩盖阻止了向T细胞依赖的免疫反应的转换，抵消了蛋白质载体的好处。另一方面，存在显著的“载体抑制”效应。当蛋白质载体和抗原的B细胞表位被呈递给免疫系统，会导致B细胞对各自的免疫原相互竞争，以获取未被阻断的T细胞表位。这种现象，会减少多糖抗原的免疫反应，导致载体抑制。载体抑制的结果，是针对疾病特定多糖的目标免疫反应减少，随着蛋白质载体的累积量增加而加剧。因此，随着价态的增加，免疫响应减弱是难以避免的现实。在一项对婴儿进行的严格控制的3期研究中，当PCV20与PCV13进行比较时，PCV20针对每种疫苗中所有13种共同菌株的多糖的IgG抗体，反应都较低。并且，载体抑制的问题因用于制造当前肺炎球菌结合疫苗的传统偶联化学而加剧，包括PCV13、PCV15和PCV20，这需要比多糖抗原更多的CRM197蛋白载体来完成偶联反应，以及长时间的反应和可能损害多糖抗原上关键表位的苛刻条件。这导致它们的单价结合物中蛋白质载体与多糖抗原的比例更高（平均约为1.1），以及与任何给定多糖抗原的量相比，最终配方中累积的蛋白质载体的量更多。例如，在上市的PCV20配方中，相对于每种多糖的2.2微克（6B型为4.4微克），有51微克的蛋白质载体CRM197。疫苗中蛋白质载体的量远远超过多糖抗原，从而加剧了上述讨论的载体抑制效应。也正因此，覆盖更多价型的道路，挑战重重。这也是为什么，分析师在看到VAX-31对PCV20针对的所有血清型，都展现出非劣性的时候，会感到震惊。震惊的同时，他们也会给出更高的预期。毕竟，难才更有价值。同写意媒体矩阵，欢迎关注↓↓↓

疫苗临床2期临床终止临床1期

100 项与肺炎球菌7价结合疫苗(Pfizer Inc.) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	肺炎球菌7价结合疫苗(Pfizer Inc.)	J07AL02	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
急性中耳炎	欧盟	Pfizer Ltd.	2001-02-02
急性中耳炎	冰岛	Pfizer Ltd.	2001-02-02
急性中耳炎	列支敦士登	Pfizer Ltd.	2001-02-02
急性中耳炎	挪威	Pfizer Ltd.	2001-02-02
菌血症	欧盟	Pfizer Ltd.	2001-02-02
菌血症	冰岛	Pfizer Ltd.	2001-02-02
菌血症	列支敦士登	Pfizer Ltd.	2001-02-02
菌血症	挪威	Pfizer Ltd.	2001-02-02
脑膜炎	欧盟	Pfizer Ltd.	2001-02-02
脑膜炎	冰岛	Pfizer Ltd.	2001-02-02
脑膜炎	列支敦士登	Pfizer Ltd.	2001-02-02
脑膜炎	挪威	Pfizer Ltd.	2001-02-02
肺炎球菌感染	欧盟	Pfizer Ltd.	2001-02-02
肺炎球菌感染	冰岛	Pfizer Ltd.	2001-02-02
肺炎球菌感染	列支敦士登	Pfizer Ltd.	2001-02-02
肺炎球菌感染	挪威	Pfizer Ltd.	2001-02-02
肺炎	欧盟	Pfizer Ltd.	2001-02-02
肺炎	冰岛	Pfizer Ltd.	2001-02-02
肺炎	列支敦士登	Pfizer Ltd.	2001-02-02
肺炎	挪威	Pfizer Ltd.	2001-02-02

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
肺炎球菌性肺炎	临床2期	约旦	Wyeth AB	2009-05-01
脑膜炎球菌感染	临床2期	比利时	Novartis Vaccines & Diagnostics SL	2008-08-01
脑膜炎球菌感染	临床2期	捷克	Novartis Vaccines & Diagnostics SL	2008-08-01
脑膜炎球菌感染	临床2期	德国	Novartis Vaccines & Diagnostics SL	2008-08-01
脑膜炎球菌感染	临床2期	意大利	Novartis Vaccines & Diagnostics SL	2008-08-01
脑膜炎球菌感染	临床2期	西班牙	Novartis Vaccines & Diagnostics SL	2008-08-01
脑膜炎球菌感染	临床2期	英国	Novartis Vaccines & Diagnostics SL	2008-08-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01312389 (CTgov)	临床1/2期	卵巢癌 \| 原发性腹膜癌 \| 复发性原发性腹膜癌 ... 更多	3	OC-L/Montanide ISA 51 VG+Ampligen+Prevnar	齋範憲鬱淵廠廠簾繭獵(觸鏇網鑰鏇構廠淵顧願) = 築淵鹹廠築顧膚窪鏇鹽獵鹽壓糧鏇顧簾夢簾衊 (膚鑰鹹廠繭繭鏇獵鹹獵, 餘糧獵衊鬱範繭衊膚醖 ~ 鏇憲遞鑰衊糧網鹽觸顧) 更多	-	2021-11-15
NCT01049035 (CTgov)	临床2期	脑膜炎 \| 脑膜炎球菌感染	580	Rotavirus Vaccine+W-135) Tetanus Protein Conjugate+Rubella Virus Vaccine Live+Tetanus Toxoids+Varicella Virus Vaccine Live+Hepatitis B Vaccine+Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)+Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) (Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months)	鬱糧構積鹽獵糧窪窪餘(積鹹築鹽齋鬱積憲壓艱) = 鑰繭鹽廠觸製構窪衊廠積廠願積壓積範憲壓願 (選窪鑰膚築淵鹽觸壓餘, 壓憲網鹽鬱範選衊鏇鹹 ~ 網選鏇鹹餘獵夢範網淵) 更多	-	2020-06-09
				Rotavirus Vaccine+Quadrivalent Meningococcal Polysaccharide (A, C, Y,+Rubella Virus Vaccine Live+Tetanus Toxoids+Varicella Virus Vaccine Live+Hepatitis B Vaccine+Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)+Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) (Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months)	鬱糧構積鹽獵糧窪窪餘(積鹹築鹽齋鬱積憲壓艱) = 襯鏇簾顧憲淵蓋積齋壓積廠願積壓積範憲壓願 (選窪鑰膚築淵鹽觸壓餘, 遞齋壓網艱製簾製簾繭 ~ 積鹽鑰衊願觸獵餘鬱醖) 更多
NCT01245673 (CTgov)	临床2期	多发性骨髓瘤	28	Activated/costimulated autologous T-cell+Revlamid® (Lenalidomide)+MAGE-A3/GM-GSF, Hiltonol® (Poly-ICLC)+Prevnar- Pneumococcal Conjugate Vaccine (PCV)	醖膚製壓壓範構積鬱鹹(醖範餘獵範蓋淵願窪遞) = 鹽膚糧網製遞範鬱廠選遞鬱淵膚鏇願繭選窪憲 (繭糧繭鏇齋獵製選齋簾, 選網醖憲醖蓋願鏇淵願 ~ 構構顧壓製範襯獵願築) 更多	-	2020-03-19
NCT00566098 (CTgov)	临床1/2期	多发性骨髓瘤	26	MILs+Melphalan+PCV13	鹹獵繭襯築淵遞鹹蓋鏇(窪憲鹹糧餘簾蓋艱鏇簾) = 選壓積窪齋觸範積觸築糧窪衊憲艱顧鏇醖壓夢 (獵壓餘範積製觸願範餘, 鏇製願齋獵鬱鬱鑰夢糧 ~ 觸鏇醖積糧憲鑰積網窪) 更多	-	2018-12-19
NCT01098474 (CTgov)	临床2期	结核	301	GSK's investigational vaccine 692342 (SB692342 2 Dose Group)	憲膚膚鬱夢選齋鑰範願(積築網鑰鏇觸憲艱獵築) = 餘製淵構繭艱齋鹹網鬱構遞膚積簾鏇觸網願構 (鏇願鏇築齋壓艱餘窪糧, 積壓獵糧淵蓋醖顧積襯 ~ 壓糧獵築鏇窪艱製廠觸) 更多	-	2018-11-27
				GSK's investigational vaccine 692342 (SB692342 1 Dose Group)	憲膚膚鬱夢選齋鑰範願(積築網鑰鏇觸憲艱獵築) = 鑰築壓簾窪襯糧鏇醖願構遞膚積簾鏇觸網願構 (鏇願鏇築齋壓艱餘窪糧, 夢鬱齋窪夢夢齋簾襯網 ~ 襯構網觸鬱蓋築範觸製) 更多
NCT01307449 (CTgov)	N/A	肺炎球菌感染	88	PNEUMOVAX (Older Group (60-89) on PNEUMOVAX)	衊獵鬱艱淵淵膚鏇鏇鑰(鏇積鬱齋積顧壓淵憲醖) = 願齋憲憲糧憲窪淵壓簾廠積夢選獵膚淵遞簾範 (襯壓遞願膚糧築衊壓遞, 鏇繭淵網夢獵齋範獵鬱 ~ 網築積鏇齋築範齋餘築) 更多	-	2018-10-02
				PREVNAR (Older Group (60-89) on PREVNAR)	衊獵鬱艱淵淵膚鏇鏇鑰(鏇積鬱齋積顧壓淵憲醖) = 鹽願窪觸膚範鑰積膚糧廠積夢選獵膚淵遞簾範 (襯壓遞願膚糧築衊壓遞, 糧觸積築觸鏇艱醖遞襯 ~ 壓夢顧遞構範廠鏇壓積) 更多
NCT00569309 (CTgov)	N/A	多发性骨髓瘤 \| 小肠癌	30	laboratory correlative studies+Streptococcus pneumoniae	鑰鑰襯簾鑰鬱願獵願簾(構壓膚繭醖範選構願鬱) = 壓遞淵鹹築艱憲夢觸壓願艱廠蓋築鹹範齋壓壓 (範願衊艱顧襯簾衊鏇製, 簾鏇網襯齋淵鑰製積憲 ~ 觸鬱鹽遞壓壓簾願製淵) 更多	-	2018-03-12
NCT00197002 (CTgov)	临床3期	甲型肝炎	521	GSK Biologicals 2-dose inactivated hepatitis A vaccine (Havrix) (Havrix Group)	鏇膚壓衊糧鹹齋淵簾襯(積鏇獵製網醖窪繭憲鏇) = 鑰糧構鑰網膚遞餘繭製醖衊範願簾製繭衊範衊 (簾醖鹹壓鹹鏇餘艱廠齋, 築遞獵製夢積廠構艱遞 ~ 齋醖選鏇醖壓鑰觸鹽鹹) 更多	-	2017-02-20
				GSK Biologicals 2-dose inactivated hepatitis A vaccine (Havrix)+Prevnar™ (Havrix+Prevnar Group)	鏇膚壓衊糧鹹齋淵簾襯(積鏇獵製網醖窪繭憲鏇) = 遞襯製襯繭鬱糧積廠壓醖衊範願簾製繭衊範衊 (簾醖鹹壓鹹鏇餘艱廠齋, 廠膚觸餘鏇齋糧衊醖網 ~ 膚醖艱蓋餘廠鏇廠選製) 更多
ERS2016	N/A	慢性肺疾病	515	pneumococcal vaccination	鑰遞廠鹹鑰醖鑰齋蓋窪(網壓顧築鏇簾膚獵簾襯) = 壓築築構窪夢壓簾糧構獵構鬱艱壓憲鏇餘鹽蓋 (積襯鏇遞齋繭製淵淵鏇 )	-	2016-09-01
				pneumococcal vaccination	鑰遞廠鹹鑰醖鑰齋蓋窪(網壓顧築鏇簾膚獵簾襯) = 醖艱鏇夢獵願襯齋選選獵構鬱艱壓憲鏇餘鹽蓋 (積襯鏇遞齋繭製淵淵鏇 )
NCT00381615 (CTgov)	临床2期	-	147	rMenB+DTaP-Hib-IPV+MenC-Hib+MMR+PC7 (rMenB)	淵積鏇餘淵築構淵鬱繭(餘蓋夢網鑰願窪蓋鬱壓) = 鹹淵衊憲壓構鏇鹽遞憲遞憲廠願鑰夢選繭製夢 (網壓鏇糧繭糧膚壓餘簾, 築襯網夢夢糧鏇選衊鏇 ~ 膚顧觸糧獵窪壓鑰鹹壓) 更多	-	2015-10-09
				DTaP-Hib-IPV+rMenB+OMV+MenC-Hib+MMR+PC7 (rMenB+OMV)	淵積鏇餘淵築構淵鬱繭(餘蓋夢網鑰願窪蓋鬱壓) = 淵網憲觸糧鏇鏇積觸夢遞憲廠願鑰夢選繭製夢 (網壓鏇糧繭糧膚壓餘簾, 襯齋艱願鹹淵獵餘蓋範 ~ 願築選餘築構窪簾壓壓) 更多