Merck (known as MSD outside of the United States and Canada) announced results from STRIDE-8, a Phase III trial evaluating Capvaxive (Pneumococcal 21-valent Conjugate Vaccine), at IDWeek 2024 in Los Angeles, California

默克公司（在美国和加拿大以外称为MSD）于2024年第三周在加利福尼亚州洛杉矶宣布了STRIDE-8的结果，STRIDE-8是一项评估Capvaxive（肺炎球菌21价结合疫苗）的III期试验

The trial evaluated the immunogenicity, safety and tolerability of Capvaxive compared to PCV15 (pneumococcal 15-valent conjugate vaccine) in combination with PPSV23 (pneumococcal 23-valent polysaccharide vaccine) in vaccine-naïve adults 18-64 years of age with certain chronic conditions that put them at an increased risk of pneumococcal disease..

该试验评估了Capvaxive与PCV15（肺炎球菌15价结合疫苗）联合PPSV23（肺炎球菌23价多糖疫苗）在18-64岁未接种疫苗的成年人中的免疫原性，安全性和耐受性，这些成年人患有某些慢性病，使他们患肺炎球菌病的风险增加。。

Key findings from the STRIDE-8 trial include: i.Capvaxive was immunogenic for all 21 serotypes (or strains) included in the vaccine, as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) (primary immunogenicity objective) and immunoglobulin G (IgG) geometric mean concentrations (GMCs) (secondary immunogenicity objective) at Day 30;ii.

STRIDE-8试验的主要发现包括：i.Capvaxive对疫苗中包括的所有21种血清型（或菌株）具有免疫原性，如通过血清型特异性调理吞噬活性（OPA）几何平均滴度（GMT）测量的（主要免疫原性目标）和免疫球蛋白G（IgG）几何平均浓度（GMC）（次要免疫原性目标）在第30天；二。

Immune responses elicited by Capvaxive were comparable to PCV15 followed by PPSV23 for the 13 common serotypes and higher for the eight serotypes unique to Capvaxive as measured by serotype-specific OPA GMTs and IgG GMCs 30 days post-vaccination; iii. The proportions of participants with adverse events (AEs), including injection-site, systemic, and vaccine-related AEs, were numerically lower in the V116 + placebo group than in the PCV15 + PPSV23 group..

疫苗接种后30天，Capvaxive引发的免疫反应与PCV15相当，其次是PPSV23，对于13种常见血清型，Capvaxive特有的8种血清型的免疫反应更高；iii.V116+安慰剂组不良事件（AE）参与者的比例（包括注射部位，全身和疫苗相关AE）在数值上低于PCV15+PPSV23组。。

“Adults with chronic medical conditions, such as kidney disease or diabetes, are particularly vulnerable to invasive pneumococcal disease, which may increase their risk of severe illness,” said Dr. Walter Orenstein, professor emeritus of medicine, epidemiology, global health and pediatrics at Emory University and member of Merck’s Scientific Advisory Committee.

埃默里大学医学、流行病学、全球健康和儿科名誉教授、默克公司科学咨询委员会成员沃尔特·奥伦斯坦博士说：“患有肾脏疾病或糖尿病等慢性疾病的成年人特别容易患侵袭性肺炎球菌病，这可能会增加他们患严重疾病的风险。”。

“These data further demonstrate that the broad serotype coverage CAPVAXIVE provides can help prevent invasive disease among vulnerable adults.”.

“这些数据进一步表明，CAPVAXIVE提供的广泛血清型覆盖率可以帮助预防易感成年人的侵袭性疾病。”。

CAPVAXIVE is indicated for: Active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in adults individuals 18 years of age and older; Active immunization for the prevention of pneumonia caused by S.

CAPVAXIVE适用于：主动免疫，用于预防18岁及以上成年人中肺炎链球菌血清型3、6A、7F、8、9N、10A、11A、12F、15A、15B、15C、16F、17F、19A、20A、22F、23A、23B、24F、31、33F和35B引起的侵袭性疾病和肺炎；主动免疫预防由S引起的肺炎。

pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older. The indication for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA).

18岁及以上个体的肺炎血清型3、6A、7F、8、9N、10A、11A、12F、15A、15C、16F、17F、19A、20A、22F、23A、23B、24F、31、33F和35B。。

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial..

是否继续批准该适应症可能取决于验证性试验中临床益处的验证和描述。。

Capvaxive should not be administered to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of CAPVAXIVE or to diphtheria toxoid; see additional Select Safety Information below.

Capvaxive不应用于对Capvaxive的任何成分或白喉类毒素有严重过敏反应（例如过敏反应）史的个体；请参阅下面的其他选择安全信息。

“The data presented during IDWeek build on the robust clinical profile of CAPVAXIVE and illustrate the importance of improving equitable access for those at high risk for invasive pneumococcal disease,” said Dr. Macaya Douoguih, Therapeutic Area Head, Vaccines Clinical Research, Merck Research Laboratories.

默克研究实验室疫苗临床研究治疗领域负责人Macaya Douoguih博士说：“IDWeek期间提供的数据建立在CAPVAXIVE强大的临床特征的基础上，并说明了改善侵袭性肺炎球菌病高危人群公平获取的重要性。”。

“Our commitment to prioritizing research and advancements that benefit populations at highest risk of invasive pneumococcal disease remains critical.”.

“我们致力于优先考虑有利于侵袭性肺炎球菌疾病风险最高人群的研究和进展，这仍然至关重要。”。

In addition to STRIDE-8, Merck also presented results from a targeted literature review of the clinical and economic burden of pneumococcal disease in U.S. adults. The findings concluded that Black adults and adults in rural areas with lower levels of education and income face higher disease burden and lower rates of pneumococcal vaccination.

除了STRIDE-8之外，默克公司还介绍了针对美国成年人肺炎球菌疾病的临床和经济负担的有针对性的文献综述的结果。调查结果表明，黑人成年人和受教育程度和收入较低的农村地区成年人面临较高的疾病负担和较低的肺炎球菌疫苗接种率。

Data from a modeling study evaluating the health impact of the introduction of Capvaxive in U.S. adults were also presented. The modeling study concluded that the use of Capvaxive in adults reduced IPD incidence by 33.9% in the U.S. after 10 years, in the setting of continued pediatric PCV vaccination.

还介绍了一项模型研究的数据，该研究评估了Capvaxive在美国成年人中引入对健康的影响。该模型研究得出的结论是，在持续接种儿科PCV疫苗的情况下，10年后，在美国成年人中使用Capvaxive可将IPD发病率降低33.9%。

This equated to approximately 14,000 fewer cases with CAPVAXIVE than PCV20 (pneumococcal 20-valent conjugate vaccine) after 10 years..

这相当于10年后CAPVAXIVE病例比PCV20（肺炎球菌20价结合疫苗）少约14000例。。

Capvaxive is specifically designed to help protect adults against the serotypes that cause the majority of invasive pneumococcal disease (IPD) cases. Based on CDC data from 2018-2021, the serotypes covered by CAPVAXIVE are responsible for more cases of IPD in adults compared to PCV20. i. In adults 50 years of age and older, Capvaxive covers the serotypes responsible for approximately 84% of IPD cases, compared to approximately 52% covered by PCV20; ii.

Capvaxive专门用于帮助保护成年人免受导致大多数侵袭性肺炎球菌病（IPD）病例的血清型感染。根据CDC 2018-2021年的数据，与PCV20相比，CAPVAXIVE覆盖的血清型导致成人IPD病例更多。i、 在50岁及以上的成年人中，Capvaxive覆盖了约84%的IPD病例的血清型，而PCV20覆盖了约52%；二。

In adults 65 years of age and older, Ca[vaxive covers the serotypes responsible for approximately 85% of IPD cases, compared to approximately 51% covered by PCV20.These values are based on CDC epidemiologic data and do not reflect the efficacy of the respective vaccines. There are currently no studies comparing the efficacy of CAPVAXIVE and PCV20..

在65岁及以上的成年人中，Ca[vaxive涵盖了约85%的IPD病例的血清型，而PCV20覆盖了约51%。这些值基于CDC流行病学数据，并不反映各自疫苗的功效。目前还没有研究比较CAPVAXIVE和PCV20的功效。。

The Phase 3 program for Capvaxive spanned multiple studies, including STRIDE-3 (NCT05425732), STRIDE-4 (NCT05464420), STRIDE-5 (NCT05526716), STRIDE-6 (NCT05420961), STRIDE-7 (NCT05393037), STRIDE-8 (NCT05696080), STRIDE-9 (NCT05633992) and STRIDE-10 (NCT05569954).

Capvaxive的第三阶段计划跨越了多项研究，包括STRIDE-3（NCT05425732），STRIDE-4（NCT05464420），STRIDE-5（NCT05526716），STRIDE-6（NCT05420961），STRIDE-7（NCT05393037），STRIDE-8（NCT05696080），STRIDE-9（NCT05633992）和STRIDE-10（NCT05569954）。

Condition: Pneumococcal Disease

病情：肺炎球菌病

Type: drug

类型：药物