作者: Muktadir, Hasneen ; Islam, Shaumik ; Islam, Samnun ; Sarower Bhuyan, Golam ; Hoque, Shahinur ; Tauheed, Imam ; Mainul Ahasan, Mohammad ; Qadri, Firdausi ; Islam Chowdhury, Mohiul ; Panday, Alex S ; Kundu Tanu, Tanni ; Shariful Bari, Shaikh ; Chowdhury, Fahima ; Rahad Hossain, Md ; Amir Hossain, Mohammad ; Masudur Rahman Mia, Md ; Ahmmed, Faisal ; Biswas, Rajib ; Karim, Mahbubul ; Muktadir Rahman Ashik, Md ; Muktadir, Abdul ; Khan, Imran ; Ahmed, Faez ; Rahman Bhuiyan, Taufiqur ; Tarikul Islam, Md ; Ahmed, Tasnuva ; Ahmed, Raziuddin

Meningococcal disease is caused by Neisseria meningitidis or meningococcus. Every year globally around 1.2 million people are affected and approximately 120,000 deaths occur due to meningitis. The disease can be prevented by a single dose of meningococcal vaccine. We carried out a randomized observer-blinded non-inferiority trial to evaluate and compare the immunogenicity and safety of a local meningococcal polysaccharide vaccine 'Ingovax ACWY' (test) with Quadri Meningo^TM (comparator), an approved meningococcal polysaccharide vaccine in India. A total of 88 healthy adults (18-45 years old) were randomized at a 1:1 ratio in two vaccine groups receiving a single dose vaccine subcutaneously. All participants were followed until three months post-vaccination. Blood for clinical parameters (hematology and biochemistry) and serum bactericidal assay (SBA) was collected prior to vaccination and one-month post-vaccination. Solicited adverse events (AEs) were assessed up to 6 days following vaccination and unsolicited AEs were monitored throughout the follow-up period. There was no significant difference in rates of AE between the two groups. The commonest solicited AE was injection site pain. No serious AEs were reported. There was no significant difference (p<0.05) in seroconversion rate as well as pre and post-vaccination SBA geometric mean titers (GMT)between test and comparator vaccine. The post-vaccination GMT ratio (GMR) of the test and comparator vaccine was found to be 0.9, 1, 1.29, and 0.85 for serogroup A, C, W135, and Y respectively. For all the serogroups, lower limit of 95% CI of the GMR was found to be greater than the pre-defined 0.5 non-inferiority margin suggesting that Ingovax ACWY is similar to Quadri Meningo^TM vaccine. We observed the immunogenicity and safety of Ingovax ACWY is non-inferior to comparator vaccine. The development of facilities for manufacturing polysaccharide ACWY vaccines locally will further lead to capacity building in the field of vaccines for Bangladesh.

2021-12-01·Vaccine3区 · 医学

Serogroup A, C, W, and Y meningococcal disease in persons previously vaccinated with a serogroup ACWY meningococcal vaccine – United States, 2014–2018

3区 · 医学

Article

作者: Mbaeyi, Sarah ; Marjuki, Henju ; McNamara, Lucy A ; Topaz, Nadav ; Blain, Amy E ; Reese, Heather E

BACKGROUNDThe Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination with a quadrivalent meningococcal conjugate serogroup A,C,W,Y (MenACWY) vaccine at 11-12 years of age, with a booster dose at 16 years. ACIP also recommends meningococcal vaccination for persons at increased risk of meningococcal disease, including a 2-dose primary series and regular booster doses for persons at increased risk because of underlying medical conditions. U.S. cases of serogroup A, C, W, and Y meningococcal disease in persons previously vaccinated with MenACWY vaccine have not been systematically described since 2008. Characterization of these cases is important to understand potential factors leading to breakthrough disease.METHODSWe analyzed cases of serogroup A,C,W, and Y meningococcal disease reported through the National Notifiable Diseases Surveillance System (NNDSS) from 2014 through 2018. State health departments submitted additional information on risk factors and clinical course.RESULTSDuring 2014-2018, 822 cases of serogroup A, C, W, and Y meningococcal disease were reported through NNDSS; 34 (4%) were in patients who previously received ≥ 1 dose of MenACWY vaccine. Twenty-three vaccinated patients were up-to-date on MenACWY vaccine per recommendations, and seven were not up-to-date; four were missing information on the number of doses received. Seventeen cases (50%) occurred > 3 years after the most recent dose. A significantly higher proportion of vaccinated patients were people living with HIV (PLWH) compared to unvaccinated patients. Eight of the 34 vaccinated patients were immunosuppressed, including five PLWH, one taking eculizumab, and two taking other immunosuppressive medications. The case fatality ratio did not differ between vaccinated and unvaccinated patients.CONCLUSIONSImmunosuppression, incomplete vaccination, and waning immunity likely contributed to breakthrough cases of meningococcal disease among people who received MenACWY vaccine. Continued monitoring of serogroup A, C, W, and Y meningococcal disease in previously vaccinated persons will help inform meningococcal disease prevention efforts.

2020-09-06·Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine]

[A phase Ⅲ clinical trial study on the safety and immunogenicity of ACYW135 group meningococcal conjugate vaccine inoculated in 3 month old infants].

Article

作者: Zhu, T ; Huang, H T ; Huang, L L ; Xie, Z Q ; Wang, Y X ; Xia, S L ; Zhao, D Y ; Xu, L F ; Gou, J B ; Wang, X ; Zhang, W ; Yang, Y L

目的： 评价国产ACYW135群脑膜炎球菌结合疫苗应用于3月龄婴儿后的安全性和免疫原性。 方法： 2017年2月至2018年6月在河南省疫苗临床研究基地采用随机、盲法、同类疫苗对照的临床试验设计，受试者为3月龄健康婴儿，共720名，按1∶1比例依据入组随机分配表随机分配到试验组和对照组，按照3、4、5月龄接种程序对研究对象分别接种试验疫苗（ACYW135群脑膜炎球菌结合疫苗）和对照疫苗（A群C群脑膜炎球菌多糖结合疫苗），其中第1针次接种720名，第2针次接种696名（试验组：346名；对照组：350名），第3针次接种692名（试验组：344 名；对照组：348 名）。采用定期随访与主动报告相结合的方式，观察疫苗接种后0~30 d内所有与疫苗有关的不良反应，在接种疫苗前和完成基础免疫后30 d分别采集约3.0 ml静脉血，用于检测和比较试验组和对照组的免疫原性。 结果： 试验组对象总体不良反应发生率为21.90%（230例），低于对照组对象的32.04%（339例）（P<0.001），其中试验组对象全身不良反应发生率为19.52%（205例）, 低于对照组对象的27.69%（293例）（P<0.001）；试验组局部不良反应发生率为3.04%（32例）, 低于对照组对象的7.84%（83例）（P<0.001）；试验组3级不良反应发生率为0.57%（6例）, 低于对照组对象的2.36%（25例）（P<0.001）。抗体阳转率结果显示，试验疫苗A群（91.42%）、C群（88.76%）与对照疫苗（92.92%）、（87.02%）相比差异无统计学意义（P>0.05），试验疫苗Y、W135群抗体阳转率分别为88.17%（298例）和99.41%（336例）。试验组对象A群抗体GMT为56.24，对照组为57.43（P>0.05）；试验组对象C群抗体GMT（43.53）高于对照组（27.28）（P<0.001）；试验组对象Y、W135群抗体GMT分别为89.22和140.66。试验组C群抗体GMT≥1∶128的比例（31.07%，105例）高于对照疫苗（16.22%，55例）（P<0.001）。 结论： 国产ACYW135群脑膜炎球菌结合疫苗应用于3月龄婴儿后具有更好的安全性和免疫原性。.

项与 A群C群脑膜炎球菌多糖结合疫苗 (北京智飞绿竹) 相关的新闻（医药）

2023-09-02

·药创客

重磅！智飞绿竹生物23价肺炎球菌多糖疫苗获批上市

点击上方图片链接报名昨日（9月1日），智飞生物宣布，其全资子公司智飞绿竹生物研发的23价肺炎球菌多糖疫苗获得中国国家药品监督管理局（NMPA）出具的《药品注册证书》，适用于2岁及以上儿童、成人预防肺炎球菌引起的感染性疾病。肺炎球菌是导致各年龄组人群社区获得性肺炎的重要病原菌，同时也是引起中耳炎、肺炎、脑膜炎和菌血症的主要病原菌。世界卫生组织将肺炎球菌疾病列为需“极高度优先”使用疫苗预防的疾病。公开资料显示，多糖荚膜是造成侵袭性肺炎球菌疾病的主要毒力因素，根据多糖组分的不同，肺炎球菌可分为约90种不同的血清型。通过对不同血清型的肺炎球菌多糖荚膜进行纯化，可制成含有不同抗原组分的多价肺炎球菌多糖疫苗。目前中国已获批的肺炎球菌疫苗主要包括13价肺炎球菌多糖结合疫苗以及23价肺炎球菌多糖疫苗两种，其中23价肺炎球菌多糖疫苗用于2岁以上适宜人群预防肺炎球菌引起的感染性疾病，是临床上预防肺炎球菌感染的最主要产品之一。根据中国药物临床试验登记与信息公示平台官网，智飞绿竹生物针对23价肺炎球菌多糖疫苗已完成一项3期临床研究，用于预防疫苗中含有的23种肺炎球菌血清型引起的肺炎、脑膜炎、中耳炎和菌血症等疾病。该研究通过随机、盲法、同类疫苗平行对照评价了23价肺炎球菌多糖疫苗在2岁及以上人群中接种的免疫原性和安全性。国内外已有多款23价肺炎球菌多糖疫苗上市。除智飞生物外，国内药企还有沃森生物、北京科兴生物、北京民海生物、成都生物制品研究所。智飞生物是一家集疫苗、生物制品研发、生产、销售、配送及进出口为一体的生物制药企业，主营人用疫苗。现在售产品包括重组新型冠状病毒蛋白疫苗(CHO细胞)(智克威得)、重组结核杆菌融合蛋白(EC,宜卡)、ACYW135群脑膜炎球菌多糖疫苗(盟威克)、A群C群脑膜炎球菌多糖结合疫苗(盟纳康)、b型流感嗜血杆菌结合疫苗(喜菲贝)、注射用母牛分枝杆菌(微卡)等自主产品及统一销售默沙东的四价人乳头瘤病毒疫苗(酿酒酵母)、九价人乳头瘤病毒疫苗(酿酒酵母)、口服五价重配轮状病毒减毒活疫苗(Vero细胞)、23价肺炎球菌多糖疫苗、甲型肝炎灭活疫苗(人二倍体细胞)等所有进口疫苗。2023上半年，公司实现营收244.45亿元，同比增长33.2%，归母净利润42.60亿元，同比增长14.2%，扣非归母净利润42.11亿元，同比增长13.5%。上半年业绩增长主要是HPV疫苗销售收入持续增长。目前，公司在研产品继续推进，拥有自主研发管线30个（不含新冠系列项目），17个处于临床阶段；其中23价肺炎多糖疫苗获批，四价流感疫苗报产获得受理，人二倍体狂苗获得Ph3临床总结报告，15价肺炎结合疫苗等多个品种处于临床后期阶段，管线逐步进入收获期。识别微信二维码，添加小编，符合条件者即可申请加入微信群！请注明：姓名+单位！声明：本文旨在传递更多信息，版权归原作者所有。原创文章转载均需经过授权并注明来源，如涉及内容、版权或其他问题请时联系小编删除！文章仅代表作者个人观点，并不代表公众号立场。本公众号拥有对此声明的最终解释权！投稿邮箱：yck19876@163.com

疫苗财报上市批准临床3期

100 项与 A群C群脑膜炎球菌多糖结合疫苗 (北京智飞绿竹) 相关的药物交易

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