A Phase IIb, Randomized, Observer-Blind Study to Describe the Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents

The purpose of this study is to assess the safety, tolerability, and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenABCWY) vaccine (GSK3536819A) intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups.

开始日期2021-12-29

申办/合作机构

GSK Plc

NCT05082285 / Active, not recruiting临床2期

A Phase II, Randomized, Partially Blinded Study to Assess the Safety, Tolerability and Immunogenicity of Meningococcal Combined ABCWY Vaccine When Administered to Healthy Infants

The purpose of this study is to assess the safety, tolerability and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenABCWY-2Gen) vaccine intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups, in healthy infants 2 months of age (MoA) at enrolment.

开始日期2021-11-29

申办/合作机构

GSK Plc

NCT04707391 / Completed临床3期

A Phase IIIB, Randomized, Controlled, Observer-blind Study to Evaluate Safety and Immunogenicity of GSK's Meningococcal ABCWY Vaccine When Administered in Healthy Adolescents and Adults, Previously Primed With Meningococcal ACWY Vaccine

The purpose of this study is to assess immunogenicity and safety of MenABCWY vaccine in healthy adolescents and adults aged 15 to 25 years previously vaccinated with MenACWY vaccine

开始日期2021-01-25

申办/合作机构

GSK Plc

100 项与 5合1脑膜炎疫苗相关的临床结果

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100 项与 5合1脑膜炎疫苗相关的转化医学

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100 项与 5合1脑膜炎疫苗相关的专利（医药）

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项与 5合1脑膜炎疫苗相关的文献（医药）

2023-08-11·The Lancet. Infectious diseases

Immunogenicity and safety of a pentavalent meningococcal ABCWY vaccine in adolescents and young adults: an observer-blind, active-controlled, randomised trial.

Article

作者: James Peterson ; Daniel Drazan ; Hanna Czajka ; Jason Maguire ; Jean-Louis Pregaldien ; IIkka Seppa ; Roger Maansson ; Robert O'Neill ; Paul Balmer ; Luis Jodar ; Kathrin U Jansen ; Annaliesa S Anderson ; John L Perez ; Johannes Beeslaar

BACKGROUND:

Meningococcal serogroups A, B, C, W, and Y cause nearly all meningococcal disease, and comprehensive protection requires vaccination against all five serogroups. We aimed to assess the immunogenicity and safety of a pentavalent MenABCWY vaccine comprising two licensed vaccines-meningococcal serogroup B-factor H binding protein vaccine (MenB-FHbp) and a quadrivalent meningococcal serogroup ACWY tetanus toxoid conjugate vaccine (MenACWY-TT)-compared with two doses of MenB-FHbp and a single dose of quadrivalent meningococcal serogroup ACWY CRM₁₉₇-conjugate vaccine (MenACWY-CRM) as the active control. We previously reported the primary safety and immunogenicity data relating to the two-dose MenB-FHbp schedule. Here we report secondary outcomes and ad-hoc analyses relating to MenABCWY immunogenicity and safety.

METHODS:

We did an observer-blind, active-controlled trial at 68 sites in the USA, Czech Republic, Finland, and Poland. Healthy individuals (aged 10-25 years) who had or had not previously received a MenACWY vaccine were randomly assigned (1:2) using an interactive voice or web-based response system, stratified by previous receipt of a MenACWY vaccine, to receive 0·5 mL of MenABCWY (months 0 and 6) and placebo (month 0) or MenB-FHbp (months 0 and 6) and MenACWY-CRM (month 0) via intramuscular injection into the upper deltoid. All individuals were masked to group allocation, except staff involved in vaccine dispensation, preparation, and administration; and protocol adherence. Endpoints for serogroups A, C, W, and Y included the proportion of participants who achieved at least a four-fold increase in serum bactericidal antibody using human complement (hSBA) titres between baseline and 1 month after each vaccination. For serogroup B, secondary endpoints included the proportion of participants who achieved at least a four-fold increase in hSBA titres from baseline for each of four primary test strains and the proportion of participants who achieved titres of at least the lower limit of quantitation against all four test strains combined at 1 month after the second dose. Endpoints for serogroups A, C, W, and Y were assessed in the modified intent-to-treat (mITT) population, which included all randomly assigned participants who received at least one vaccine dose and had at least one valid and determinate MenB or serogroup A, C, W, or Y assay result before vaccination up to 1 month after the second dose, assessed in ACWY-experienced and ACWY-naive participants separately. Secondary endpoints for serogroup B were analysed in the evaluable immunogenicity population, which included all participants in the mITT population who were randomly assigned to the group of interest, received all investigational products as randomly assigned, had blood drawn for assay testing within the required time frames, had at least one valid and determinate MenB assay result after the second vaccination, and had no important protocol deviations; outcomes were assessed in both ACWY-experienced and ACWY-naive populations combined. Non-inferiority of MenABCWY to MenACWY-CRM and MenB-FHbp was determined using a -10% non-inferiority margin for these endpoints. Reactogenicity and adverse events were assessed among all participants who received at least one vaccine dose and who had available safety data. This trial is registered with Clinicaltrials.gov, NCT03135834, and is complete.

FINDINGS:

Between April 24 and November 10, 2017, 1610 participants (809 MenACWY-naive; 801 MenACWY-experienced) were randomly assigned: 544 to receive MenABCWY and placebo (n=272 MenACWY-naive; n=272 MenACWY-experienced) and 1066 to receive MenB-FHbp and MenACWY-CRM (n=537 MenACWY-naive; n=529 MenACWY-experienced). Among MenACWY-naive or MenACWY-experienced MenABCWY recipients, 75·5% (95% CI 69·8-80·6; 194 of 257; serogroup C) to 96·9% (94·1-98·7; 254 of 262; serogroup A) and 93·0% (88·4-96·2; 174 of 187; serogroup Y) to 97·4% (94·4-99·0; 224 of 230; serogroup W) achieved at least four-fold increases in hSBA titres against serogroups ACWY after dose 1 or 2, respectively, in ad-hoc analyses. Additionally, 75·8% (71·5-79·8; 320 of 422) to 94·7% (92·1-96·7; 396 of 418) of MenABCWY and 67·4% (64·1-70·6; 563 of 835) to 95·0% (93·3-96·4; 782 of 823) of MenB-FHbp recipients achieved at least four-fold increases in hSBA titres against MenB strains after dose 2 in secondary analyses; 79·9% (334 of 418; 75·7-83·6) and 74·3% (71·2-77·3; 605 of 814), respectively, achieved composite responses. MenABCWY was non-inferior to MenACWY-CRM (single dose) and to MenB-FHbp in ad-hoc analyses based on the proportion of participants with at least a four-fold increase in hSBA titres from baseline and (for MenB-FHbp only) composite responses. Reactogenicity events after vaccination were similarly frequent across groups, were mostly mild or moderate, and were unaffected by MenACWY experience. No adverse events causing withdrawals were related to the investigational product. Serious adverse events were reported in four (1·5%; 0·4-3·7) MenACWY-naive individuals in the MenABCWY group versus six (2·2%; 0·8-4·8) among MenACWY-experienced individuals in the MenABCWY group and 14 (1·3%; 0·7-2·2) in the active control group (MenACWY-experienced and MenACWY-naive individuals combined); none of these were considered related to the investigational product.

INTERPRETATION:

MenABCWY immune responses were robust and non-inferior to MenACWY-CRM and MenB-FHbp administered separately, and MenABCWY was well tolerated. The favourable benefit-risk profile supports further MenABCWY evaluation as a simplified schedule compared with current adolescent meningococcal vaccination programmes.

FUNDING:

Pfizer.

2022-09-07·The Journal of infection

Public health perspective of a pentavalent meningococcal vaccine combining antigens of MenACWY-CRM and 4CMenB.

Review

作者: Rafik Bekkat-Berkani ; Elena Fragapane ; Scott Preiss ; Rino Rappuoli ; Woo-Yun Sohn ; Lamine Soumahoro ; Kumaran Vadivelu

OBJECTIVES:

Invasive meningococcal disease (IMD) is a life-threatening disease that can rapidly progress to death or leave survivors with severe, life-long sequelae. Five meningococcal serogroups (A, B, C, W and Y) account for nearly all IMD. Meningococcal serogroup distribution fluctuates over time across the world and age groups. Here, we consider the potential public health impact of a pentavalent MenABCWY vaccine developed to help further control meningococcal disease and improve immunisation rates.

RESULTS:

The GSK MenABCWY vaccine combines the antigenic components of MenACWY-CRM (Menveo®) and 4CMenB (Bexsero®), building on a wide body of clinical experience and real-world evidence. Both approved vaccines have acceptable safety profiles, demonstrate immunogenicity, and are broadly used, including in national immunisation programmes in several countries. Since the advent of quadrivalent vaccines, public health in relation to IMD has improved, with a decline in the overall incidence of IMD and an increase in vaccine coverage.

CONCLUSION:

A pentavalent MenABCWY has the potential to provide further public health benefits through practical, broad IMD protection programmes encompassing serogroups A, B, C, W and Y, and is currently in late-stage development.

2022-03-31·Infectious diseases and therapy3区 · 医学

Rationale for the Development of a Pentavalent Meningococcal Vaccine: A US-Focused Review.

3区 · 医学

ReviewOA

作者: Gary S Marshall ; Jaime Fergie ; Jessica Presa ; Paula Peyrani

While invasive meningococcal disease (IMD) is uncommon, it can result in serious sequelae and even death. In 2018 in the United States, the incidence of IMD per 100,000 people was 0.03 among adolescents 11-15 years of age, 0.10 among persons 16-23 years of age, and 0.83 among infants < 1 year of age. Serogroup B accounted for 86%, 62%, and 66% of cases, respectively, in those age groups. Currently, routine meningococcal vaccination covering serogroups ACWY (MenACWY) is recommended in the United States for all adolescents at 11-12 years of age, with a booster dose at 16 years of age, whereas a meningococcal serogroup B (MenB) vaccine series is recommended for persons 16-23 years of age under the shared clinical decision-making paradigm. The MenACWY vaccination program in adolescents has been successful in reducing disease burden, but does not prevent disease caused by serogroup B, which accounts for more than half of IMD cases. There are currently no approved vaccines that cover all of the most common disease-causing meningococcal serogroups, which are A, B, C, W, and Y. A pentavalent MenABCWY vaccine that is constituted from 2 licensed meningococcal vaccines-MenB-FHbp and MenACWY-TT-is being investigated in healthy persons ≥ 10-25 years of age. The addition of a MenABCWY vaccine is the next natural step in the incremental meningococcal immunization program in the United States to improve protection against the most common serogroup causing IMD, with no increase in the number of immunizations needed. With high uptake, routine use of MenABCWY could reduce IMD cases and associated mortality, the rate of long-term physical and psychosocial sequelae in survivors, and costs associated with controlling outbreaks, particularly on college campuses. A MenABCWY vaccine would also reduce the number of injections required for adolescents, potentially improving compliance.

项与 5合1脑膜炎疫苗相关的新闻（医药）

2023-10-20

·FiercePharma

Pfizer beats out GSK with FDA nod for first 5-in-1 meningitis shot

While Pfizer’s approval has won Penbraya some time to its own on the market, GSK is close behind with its own pentavalent competitor. In the race to secure U.S. approval for the first five-pronged meningitis vaccine, Pfizer has eked out a regulatory win well ahead of its immunization rival GSK. Friday, the U.S. FDA gave a thumbs-up to Penbraya, the commercial moniker for Pfizer’s pentavalent vaccine defending against the most common serogroups behind meningococcal disease. The shot is approved for adolescents and adults between the ages of 10 and 25. Penbraya mixes components from two of the company’s other meningococcal vaccines—Trumenba and Nimenrix—which together tackle serogroups A, B, C, W and Y. Those serogroups account for nearly all invasive meningococcal disease. Prior to Pfizer’s Penbraya approval, protection from all five groups required four injections from two separate vaccines. Chief to Pfizer’s marketing pitch for Penbraya is that the shot needs only be administered twice. The company figures this feature will streamline standard of care and potentially boost the number of people who get vaccinated. The FDA handed Pfizer its regulatory win based on results from the company’s phase 2 and phase 3 trials, which included a late-stage study pitting Pfizer’s pentavalent shot against other meningitis vaccines currently approved in the U.S. Besides Pfizer, GSK’s Bexsero has competed with Trumenba for the meningococcal B vaccine market. GSK also makes Menveo, a vaccine against meningococcal groups A, C, W-135 and Y. Sanofi separately markets its own MenACWY vaccines called Menactra and MenQuadfi. Now, though, Pfizer is poised to disrupt the market with a shot that protects against the serogroups A, B, C, W and Y. Beyond the shot’s approval, the Centers for Disease Control and Prevention’s advisory committee on immunization practices is set to weigh in on how Pfizer’s vaccine should be used on Oct. 25. While Pfizer’s approval has won Penbraya some time to its own on the market, GSK is close behind with its own pentavalent competitor, coded MenABCWY. In May, GSK unveiled study results pitting the investigational MenABCWY vaccine against a combination of Bexsero and Menveo. GSK found its vaccine candidate was noninferior to the Bexsero-Menveo combination in people aged 10 to 25 years across all five of the targeted serotypes.

上市批准临床结果疫苗临床2期临床3期

2023-08-03

·生物制品圈

辉瑞、默沙东2023Q2财报发布，这4款潜力疫苗产品值得期待！（附报告下载）

8月1日，全球疫苗四大天王中的另外两家——辉瑞和默沙东也相继公布了2023H1业绩：辉瑞今年上半年总营收310亿美元，同比降低42%。其中Q2收入127亿美元，同比降低54%；若不计新冠产品，则同比增长5%。业绩总体下滑的主要原因是新冠口服药Paxlovid和新冠疫苗Comirnaty的患者需求下降。默沙东今年上半年总营收295.22亿美元，同比下降3%。其中Q2收入150.35亿美元，同比增长3%。业绩总体下滑的主要是由于新冠药物Lagevrio的收入大幅减少（-87%）以及两款降糖药销售下滑。下面主要看看这两家企业疫苗板块的情况。（赛诺菲、GSK 2023Q2财报发布，这5款疫苗产品值得关注！附最新管线）PS：在【药时空】公众号后台回复关键词“2023Q2”，即可获取辉瑞、默沙东、GSK、赛诺菲2023Q2业绩报告资料！辉瑞2023年上半年，辉瑞的新冠mRNA疫苗Comirnaty销售额45.52亿美元，肺炎结合疫苗Prevnar销售额29.81亿美元。其中，美国的COVID-19疫苗接种量为1240万剂，虽低于辉瑞此前的预测（1亿剂），但COVID-19疫苗的市场份额超过其之前的预测（60%）。在未来的疫苗业绩贡献方面，辉瑞刚获批的RSV疫苗有望成长为超级重磅炸弹；肺炎结合疫苗20价上市迭代13价，有望巩固其在肺炎球菌疫苗领域的市场地位。辉瑞的RSV二价疫苗 Abrysvo是于今年5月底获FDA批准上市，用于预防60岁及以上人群由RSV引起的急性呼吸道疾病和下呼吸道疾病。其也是全球第2款获批的RSV疫苗。在辉瑞的疫苗在研管线中，可以关注一下五价脑膜炎球菌疫苗MenABCWY和B组链球菌候选疫苗GBS6。MenABCWY辉瑞预计2023年下半年将是新药/新适应症推向市场的密集期，并将带来高于上半年的高增长。在疫苗方面，比较值得关注的待获批新药为五价脑膜炎球菌疫苗MenABCWY。2022年年底，辉瑞的MenABCWY的BLA获美国FDA受理，用于预防10-25岁人群中最常见血清群引起的脑膜炎球菌病。FDA预计将于2023年10月做出决定。MenABCWY是辉瑞2款已上市疫苗Trumenba（B型脑膜炎球菌疫苗）和Nimenrix（脑膜炎球菌A、C、W-135与Y偶联疫苗）的结合，该疫苗涵盖了五种常见的侵袭性脑膜炎球菌血清群（脑膜炎球菌A、B、C、W、Y）。如果该疫苗获批，将会成为首个涵盖所有常见脑膜炎球菌血清群的单一疫苗。GBS6在更长时间段的管线方面，辉瑞有一款六价荚膜多糖（CPS）B组链球菌（GBS）候选疫苗GBS6，该疫苗的2期临床试验结果被发表在了《新英格兰医学杂志》上。GBS6用于给母亲接种，以保护婴儿免受侵袭性GBS疾病的影响。而据这项研究结果显示，母亲接种疫苗后所生婴儿体内的抗CPS IgG浓度>0.184 µg/mL。免疫原性最强的制剂达到57%-97%的血清应答率。GBS6可为新生儿提供有意义的抗侵袭性GBS疾病的保护。另外，辉瑞的其他疫苗在研管线还包括COVID /流感mRNA联合疫苗、莱姆病疫苗（PF405）、mRNA带状疱疹疫苗等。默沙东2023年上半年，默沙东在制药业务领域的主要收入来源是帕博利珠单抗（Keytruda，K药）和HPV疫苗Gardasil/Gardasil 9，二者合计贡献164.95亿美元，占该部分收入63%。其中，Gardasil/Gardasil 9的销售额为44.3亿美元，同比增长41%，主要来自国际市场的增长。另外，Gardasil/Gardasil 9在2023Q2的销售额为24.59亿美元，同比增长47%。2022年8月，Gardasil 9在中国扩龄至9-45岁女性，这促使其销售额实现强劲增长。据默沙东预计，2023年Gardasil/Gardasil 9的销售额将突破2022年的数据（68.97亿美元）。除Gardasil/Gardasil 9外，在疫苗领域，今年上半年默沙东的麻腮风-水痘疫苗/麻腮风疫苗/水痘疫苗ProQuad/M-M-R II/Varivax的销售额为11.09亿美元、五价轮状病毒疫苗RotaTeq的销售额为4.28亿美元、15价肺炎球菌多糖结合疫苗Vaxneuvance的销售额为2.74亿美元、23价肺炎球菌多糖疫苗Pneumovax 23的销售额为1.88亿美元、灭活甲肝疫苗Vaqta的销售额为0.82亿美元。其中，除了Pneumovax 23的销售额同比下降42%外，其他几款疫苗产品均实现了不同程度的增长。在默沙东的疫苗在研管线中，V116和mRNA-4157这2款疫苗产品值得注意，可能成为公司未来贡献销售增长的潜力产品，目前这两款产品均处于III期临床阶段。V1167月底，默沙东宣布其21价肺炎球菌结合疫苗（PCV21）V116的两项3期临床试验（STRIDE-3；STRIDE-6）均获积极顶线结果。V116是一种处于临床3期开发中的21价肺炎球菌结合疫苗，用于预防成年人侵袭性肺炎球菌疾病和肺炎球菌肺炎。V116包括8种独特的血清型——15A、15C、16F、23A、23B、24F、31 和 35B，这些血清型约占成人发病的30%。据默沙东表示，如果V116获批上市，将成为第一个专为成年人设计的肺炎球菌结合疫苗。另外，基于V116的3期临床试验，后续将有潜力扩大血清型覆盖范围，进一步帮助 85% 以上的65岁及以上人群预防侵袭性肺炎球菌疾病。mRNA-4157同样是在7月底，默沙东和Moderna宣布启动肿瘤新抗原mRNA疫苗（mRNA-4157）+Keytruda联合辅助治疗可手术的IIB-IV期高危黑色素瘤的关键性3期临床试验（V940-001）。目前，该试验已经开始了全球患者的招募，且首批患者正在澳大利亚入组。mRNA-4157是针对每个癌症患者的独特肿瘤突变开发的一款个性化肿瘤新抗原疫苗，包含编码最多34种新抗原的单一合成mRNA分子，其设计目标是根据患者肿瘤的突变特征，通过产生T细胞反应来刺激免疫反应。2023年，该疫苗先后获得了FDA的突破性疗法认证和EMA授予的优先药物（PRIME）资格，并成为全球首个获此认证的mRNA肿瘤疫苗。V940-001试验为随机、双盲、安慰剂和活性参比对照设计，计划在超25个国家、超165个中心入组约1089例黑色素瘤患者。试验的主要终点是无复发生存期（RFS），次要终点包括无远处转移生存期、总生存期（OS）和安全性。另外，通过查询clinicaltrials.gov上登记的关于V940-001试验的信息显示，该研究预计将于2029年10月完成。参考资料：[1]辉瑞、默沙东2023Q2业绩报告材料[2]曾经的疫苗之王要被新产品替代了？.新康界.2023-07-29.[3]默沙东21价肺炎球菌结合疫苗3期临床试验达到关键终点，或成为首个成年人用肺炎球菌结合疫苗.RNAScript.2023-07-29.[4]最广泛覆盖率！辉瑞五价脑膜炎球菌疫苗上市申请获FDA受理.药融圈.2023-01-02.[5]速递|预防每年造成超13万新生儿死亡的疾病，辉瑞疫苗2期临床结果积极.药明康德.2023-07-25.相关阅读：赛诺菲、GSK 2023Q2财报发布，这5款疫苗产品值得关注！（附最新管线）

财报疫苗信使RNA上市批准

2023-08-02

·生物制品圈

赛诺菲、GSK 2023Q2财报发布，这5款疫苗产品值得关注！（附最新管线）

近日，全球疫苗四大天王中的两家——赛诺菲和GSK公布了2023H1业绩：赛诺菲净收入201.87亿欧元，同比增长4.4%，其中生物制药业务收入174.67亿欧元（+4.1%），疫苗业务收入23.90亿欧元（+11.9%），消费者保健业务收入27.20亿欧元（+6.1%）；GSK总营收141.29亿英镑，同比下降2%，其中专科药物营收47.59亿英镑（+21 %），疫苗营收40.63亿英镑（+16%），普药营收53.07亿英镑（+8%。）。下面主要看看这两家企业疫苗板块的情况。赛诺菲2023上半年，赛诺菲疫苗板块营收为23.90亿欧元，同比增长11.9%，表现强劲。具体到2023Q2季度，其疫苗板块营收12.23亿欧元，同比增长9.1%；其中，流感疫苗营收0.99亿欧元（-10.4%）、脊髓灰质炎系列疫苗营收6.17亿欧元（+12.4）、加强疫苗营收1.50亿欧元（+0.7%）、脑膜炎疫苗/旅行和地方性疫苗营收2.70亿欧元（-5.7%），其他疫苗营收0.87亿欧元（+258.3%）。在流感疫苗方面，2023年赛诺菲的流感疫苗销售情况与去年同期大致持平。流感疫苗表现的关键驱动因素为Efluelda在欧盟市场主要市场的扩张；在世界其他地区，四价流感疫苗（QIV）逐步替代三价流感疫苗（TIV）。流感疫苗表现的关键阻碍因素为疫苗接种覆盖率仍低于大流行前的水平；标准剂量疫苗的净价格遭受侵蚀。在疫苗管线的进展方面，赛诺菲提到了SP0202 (PCV21)、SP0125 (RSV toddler)和Beyfortus这三个产品。SP0202 (PCV21)PCV21是由SK bioscience与赛诺菲联合研发的21价肺炎球菌结合候选疫苗，其将特定蛋白与肺炎链球菌的多糖荚膜相结合。该疫苗覆盖21种血清型，高于目前市场上使用的PCV/13/15/20疫苗。据赛诺菲公布的PCV21疫苗的临床2期试验结果显示，该疫苗在安全性和免疫原性表现积极：PCV21在儿童人群中耐受性良好，所有4种剂量的安全性均与PCV13相当；与PCV20相比，PCV21的免疫反应良好。另外，PCV21不会干扰共同接种的推荐儿科疫苗（例如破伤风、白喉、百日咳、脊髓灰质炎和B型流感嗜血杆菌疫苗）的免疫原性和安全性。预计该疫苗将于2024年上半年启动临床3期试验，并于2027年提交上市申请。SP0125 (RSV toddler)SP0125为一款减毒活疫苗，也是首个被设计可用于保护所有幼儿的的RSV疫苗。据SP0125的1/2期数据显示，在安全性方面，SP0125与安慰剂类似；在疫苗应答方面，两次使用高剂量配方后，SP0125的疫苗反应强烈（93%），另外，低剂量和高剂量配方之间存在边际差异。赛诺菲预计该疫苗将于2024年上半年进入3期临床，并于2026年提交上市申请。BeyfortusBeyfortus是全球首个且唯一可广泛应用于婴儿人群的RSV预防用长效单克隆抗体，由赛诺菲和阿斯利康联合开发，通过结合表达于病毒粒子和受染细胞表面的RSV融合（F）蛋白达到中和RSV的目的，用于预防由RSV引起的下呼吸道疾病。据赛诺菲公布的Beyfortus 3b期临床试验HARMONIE的数据显示：该疫苗接种新生儿可以将RSV相关下呼吸道症状住院率降低83%，预计比孕妇接种RSV疫苗有效率高出3倍。2022年11月，Beyfortus获欧盟委员会批准，作为单剂量被动免疫疗法，用于所有新生儿和婴儿，在其第一个RSV季节预防RSV下呼吸道疾病（LRTI）；今年4月，该疫苗在加拿大获批上市；7月，Beyfortus又获得了FDA的监管批准。与GSK和辉瑞的RSV疫苗相比，Beyfortus聚焦的是婴儿群体，而前者则针对的是60岁及以上的老年人群。也就是说，目前Beyfortus在婴儿RSV预防领域尚无竞争对手。据赛诺菲预计，到2030年婴儿RSV预防市场的规模约为25亿欧元。葛兰素史克2023上半年，GSK疫苗板块营收为40.63亿欧元。具体到2023Q2季度，其疫苗板块营收20.22亿英镑，同比增长18%，与一季度持平，若不包含新冠业务则增长15%。其中，GSK的当家单品带状疱疹疫苗Shingrix继续保持强劲增势：2023年上半年，Shingrix营收17.13亿英镑，约等于2021年的全年销售额（17.21亿英镑）。Shingrix强劲的销售表现主要得益于其在全球范围内的扩张和需求的增长。值得注意的是，在报告期内Shingrix在日本获批用于18岁以上及高危成年人带状疱疹，目前Shingrix已在33个国家/地区获批上市。除了Shingrix外，同样保持双位数增长的还有脑膜炎疫苗，主要由b型脑膜炎疫苗Bexsero驱动。由于市场需求的增加以及被纳入国家免疫计划，Bexsero在2023Q2季度的销售额继续保持增长态势。在GSK的疫苗管线中，Arexvy和MenABCWY是公司的高潜力产品，预计其将推动公司业绩在未来几年内的持续增长。Arexvy是由RSV融合前（prefusion）F糖蛋白（RSVPreF3）与GSK公司专有的佐剂组合而成的一款RSV疫苗产品。2023年5月，Arexvy获得FDA批准上市，用于预防60岁及以上人群因RSV引起的下呼吸道疾病（LRTD），其也是全球首个获得监管机构批准的RSV疫苗。2023年6月，Arexvy在欧盟获批上市。据GSK表示，该疫苗产品是公司下一波疫苗创新的前沿。MenABCWY是一款脑膜炎疫苗Bexsero（脑膜炎球菌B群疫苗）和Menveo（脑膜炎球菌A、C、W和Y组结合疫苗）的结合疫苗。2023年5月，GSK公布了MenABCWY组合疫苗在3期试验中的初步积极结果：该候选疫苗在10-25岁的健康个体中间隔6个月接种两次，与接种2剂Bexsero和1剂Menveo相比，候选疫苗在5种奈瑟菌属脑膜炎球菌血清群（A、B、C、W和Y）的主要终点方面表现出非劣效性。此外，MenABCWY候选疫苗还在临床试验中表现出对110种不同的B型脑膜炎球菌（MenB）侵袭性菌株（占流行菌株的95%）的免疫效果。候选疫苗通常耐受良好，安全性特征与Bexsero和Menveo一致。截至目前，GSK共有68个疫苗产品和药品在研，17项已进入临床3期，覆盖抗感染、疫苗、传染、呼吸、肿瘤等领域。其中，疫苗管线有21个，包括1个注册，3个临床3期、9个临床2期、8个临床1期。此外，GSK还针对疫苗领域进行了2023年全年展望：排除大流行佐剂的销售，则销售额预计将增长15%左右，预计Shingrix将继续保持两位数增长，销量将再创佳绩；脑膜炎疫苗销售额预计将增长15%左右；流感疫苗预计销售额将下降，降幅降低至个位数。参考资料：赛诺菲、GSK 2023Q2业绩报告材料相关阅读：赛诺菲疫苗管线最新进展：12款候选产品，2年内推动5个项目进临床3期

财报疫苗临床3期

100 项与 5合1脑膜炎疫苗相关的药物交易

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研发状态

适应症	最高研发状态	国家/地区	公司
流行性脑脊髓膜炎	临床3期	加拿大更多	GlaxoSmithKline, Inc. 更多

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临床结果

适应症

分期

评价

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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


NCT02946385 (CTgov)	临床2期	脑膜炎球菌感染	604	MenABCWY (ABCWY_0_2)	蓋製淵艱鹽艱製窪壓構(遞廠鏇積範夢願鏇鹽鹽) = 憲遞鹽獵遞網鬱膚餘壓蓋醖蓋糧餘襯繭築繭鹹 (醖簾鹹壓製齋製鹹觸夢, 夢願繭範壓遞壓艱鹽膚 ~ 衊鹽鏇積簾顧襯憲鹹鑰) 更多	-	2019-08-20
				MenABCWY (ABCWY_0_2_6)	蓋製淵艱鹽艱製窪壓構(遞廠鏇積範夢願鏇鹽鹽) = 鹽繭網鹽顧築網鏇鑰蓋蓋醖蓋糧餘襯繭築繭鹹 (醖簾鹹壓製齋製鹹觸夢, 網憲襯鏇蓋觸鑰簾繭網 ~ 壓艱淵蓋鬱積糧窪齋選) 更多
NCT02140762 (Pubmed \| Vaccine)	临床2期	侵袭性真菌感染	301	MenABCWY vaccine (MenABCWY)	繭餘餘顧願糧顧艱鹽築(顧範鏇鑰觸鹹醖顧獵願) = 衊製遞淵鏇淵獵鹽獵鹽積簾鹹壓窪鏇構網觸鬱 (繭蓋範獵遞顧膚築築選, 65 ~ 69)	-	2018-08-23
NCT02140762 (CTgov)	临床2期	脑膜炎球菌感染	305	MenABCWY (MenABCWY)	廠範夢鑰鑰顧範顧鹽窪(遞構願繭夢憲壓繭餘鑰) = 糧範鹽簾蓋醖鑰憲鑰醖繭廠願觸獵夢鹽淵襯膚 (衊襯鑰獵窪餘鹽襯製襯, 艱壓製襯蓋鏇餘蓋鹽網 ~ 醖顧顧襯膚艱蓋觸遞鏇) 更多	-	2018-06-26
				Placebo+MenACWY (Placebo/MenACWY)	廠範夢鑰鑰顧範顧鹽窪(遞構願繭夢憲壓繭餘鑰) = 繭壓淵築構醖餘襯齋衊繭廠願觸獵夢鹽淵襯膚 (衊襯鑰獵窪餘鹽襯製襯, 繭積網糧構願窪鏇糧範 ~ 鏇觸鏇夢餘糧蓋齋膚糧) 更多
NCT02451514 (CTgov)	临床2期	脑膜炎球菌感染	129	MenABCWY+OMV vaccine (MenABCWY+OMV Group)	鏇鑰夢廠製遞鏇憲壓廠(醖膚膚壓餘齋齋願膚淵) = 襯積繭簾願衊壓遞積襯鑰膚廠憲醖廠願壓鑰憲 (鹽壓範鹽範製餘選蓋鹽, 衊窪夢築醖齋願觸蓋餘 ~ 構觸襯醖願網淵範壓醖) 更多	-	2020-07-09
				MenABCWY+OMV vaccine (MenACWY Group)	鏇鑰夢廠製遞鏇憲壓廠(醖膚膚壓餘齋齋願膚淵) = 範鹽醖築憲齋積襯願顧鑰膚廠憲醖廠願壓鑰憲 (鹽壓範鹽範製餘選蓋鹽, 餘範壓齋窪襯積壓鑰製 ~ 獵繭蓋夢鑰夢齋製選夢) 更多
NCT02285777 (CTgov)	临床2期	脑膜炎球菌感染	189	Meningococcal ABCWY (MenABCWY Group)	鏇醖襯齋觸網窪選壓淵(鑰鏇簾鹽壓憲繭積蓋衊) = 齋積淵遞糧鑰獵艱積壓鹽廠鬱淵繭繭鏇網範繭 (鏇夢鹽壓構遞憲衊構繭, 網餘網憲膚鹹壓鹽憲壓 ~ 顧襯憲選鏇壓餘網築獵) 更多	-	2017-12-06
				Placebo (MenACWY Group)	鏇醖襯齋觸網窪選壓淵(鑰鏇簾鹽壓憲繭積蓋衊) = 蓋糧膚觸簾襯醖鬱築願鹽廠鬱淵繭繭鏇網範繭 (鏇夢鹽壓構遞憲衊構繭, 獵醖鬱觸廠鏇顧糧繭繭 ~ 蓋顧衊繭鑰窪網鑰範襯) 更多
NCT04502693 (CTgov)	临床3期	脑膜炎球菌感染	3,657	rMenB+OMV NZ vaccine+Y Conjugate Vaccine (MenACWY) (MenB_0_2_6 Group)	願築膚夢艱糧襯製選鹹(壓壓糧衊淵蓋壓糧廠壓) = 壓築積願醖鹽鑰選願淵簾範鹽簾繭艱繭構積蓋 (遞夢範壓鹹淵襯壓觸遞, 壓選窪顧網積夢製積艱 ~ 構鹹蓋鏇膚廠遞構觸選) 更多	-	2024-03-05
				Placebo+rMenB+OMV NZ vaccine+Y Conjugate Vaccine (MenACWY) (MenB_0_6 Group)	願築膚夢艱糧襯製選鹹(壓壓糧衊淵蓋壓糧廠壓) = 範壓糧淵觸憲簾願淵襯簾範鹽簾繭艱繭構積蓋 (遞夢範壓鹹淵襯壓觸遞, 糧構製鬱衊鹽獵網顧鑰 ~ 鑰選觸觸壓願願膚窪鹹) 更多