October 16, 2024 6:45 am ET

美国东部时间 2024 年 10 月 16 日上午 6：45

STRIDE-8 results presented at IDWeek build on the proven clinical profile of CAPVAXIVE, marking the latest Phase 3 study evaluating CAPVAXIVE to demonstrate robust immune responses in adults

IDWeek上公布的STRIDE-8结果建立在CAPVAXIVE已被证实的临床特征的基础上，标志着评估CAPVAXIVE的最新3期研究证明了成年人的强大免疫反应

CAPVAXIVE covers the serotypes responsible for approximately 84% of invasive pneumococcal disease cases in adults 50 and older

CAPVAXIVE涵盖了50岁及以上成年人中约84%的侵袭性肺炎球菌病病例的血清型

RAHWAY, N.J.--(BUSINESS WIRE)--

新泽西州拉威（RAHWAY）--（商业新闻）--

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from STRIDE-8, a Phase 3 trial evaluating CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine), at IDWeek 2024 in Los Angeles, California. 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..

默克（纽约证券交易所代码：MRK），在美国和加拿大以外被称为MSD，今天宣布了STRIDE-8的结果，STRIDE-8是一项评估CAPVAXIVE™（肺炎球菌21价结合疫苗）的3期临床试验，于2024年在加利福尼亚州洛杉矶举行。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:

STRIDE-8试验的主要发现包括：

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;.

CAPVAXIVE在第30天通过血清型特异性调理吞噬活性（OPA）几何平均滴度（GMT）（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）测量，对疫苗中包括的所有21种血清型（或菌株）具有免疫原性；。

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;

根据接种疫苗后 30 天的血清型特异性 OPA GMT 和 IgG GMC 测量，CAPVAXIVE 引发的免疫反应与 PCV15 相当，其次是 PPSV23，而 CAPVAXIVE 特有的 8 种血清型的免疫反应则更高;

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.

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。”。

“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（Merck Research Laboratories）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风险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。

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.

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。

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;

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%；

In adults 65 years of age and older, CAPVAXIVE covers the serotypes responsible for approximately 85% of IPD cases, compared to approximately 51% covered by PCV20.

在65岁及以上的成年人中，CAPVAXIVE覆盖了约85%的IPD病例的血清型，而PCV20覆盖了约51%。

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.

这些值基于CDC流行病学数据，并不反映各自疫苗的功效。目前还没有比较CAPVAXIVE和PCV20疗效的研究。

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）

STRIDE-8 (NCT05696080) is a Phase 3, randomized, double-blind, active comparator-controlled clinical study, evaluating the immunogenicity, safety and tolerability of CAPVAXIVE in adults 18-64 years of age with increased risk for pneumococcal disease (including adults who experienced diabetes mellitus, heart disease, kidney disease, liver disease and lung disease) who had not previously received a pneumococcal vaccine (n=518).

STRIDE-8（NCT05696080）是一项3期，随机，双盲，主动比较对照临床研究，评估CAPVAXIVE在18-64岁成年人中的免疫原性，安全性和耐受性，肺炎球菌疾病风险增加（包括经历过糖尿病，心脏病，肾脏病，肝病和肺部疾病的成年人），他们以前没有接受过肺炎球菌疫苗（n=518）。

Immunogenicity of CAPVAXIVE was compared with sequential administration of PCV15 followed by PPSV23. Participants were randomized 3:1 to receive a single dose of CAPVAXIVE on Day 1 followed by placebo at Week 8, or a single dose of PCV15 on Day 1 followed by a single dose of PPSV23 at Week 8..

将CAPVAXIVE的免疫原性与依次给予PCV15和PPSV23进行比较。参与者在第1天以3:1的比例随机接受单剂量CAPVAXIVE，然后在第8周接受安慰剂，或者在第1天接受单剂量PCV15，然后在第8周接受单剂量PPSV23。。

Primary objectives included serotype-specific OPA GMTs and IgG GMCs at Day 1 and 30-days post-vaccination (Day 30 for CAPVAXIVE + placebo and Week 12 for PCV15 + PPSV23). Safety was evaluated as the proportion of participants with adverse events. Results showed that:

主要目标包括疫苗接种后第1天和第30天的血清型特异性OPA GMT和IgG GMC（CAPVAXIVE+安慰剂的第30天和PCV15+PPSV23的第12周）。安全性评估为不良事件参与者的比例。结果表明：

CAPVAXIVE was immunogenic for all 21 serotypes included in the vaccine, as measured by OPA GMTs and IgG GMCs at Day 30;

如在第30天通过OPA GMT和IgG GMC测量的，CAPVAXIVE对疫苗中包括的所有21种血清型具有免疫原性；

Immune responses elicited by CAPVAXIVE were comparable to PCV15 and PPSV23 for the 13 common serotypes (3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F and 33F) with higher responses for the eight serotypes unique to CAPVAXIVE (15A, 15C, 16F, 23A, 23B, 24F, 31 and 35B) as measured by serotype-specific OPA GMTs and IgG GMCs 30 days post-vaccination;.

对于13种常见血清型（3,6A，7F，8,9N，10A，11A，12F，17F，19A，20A，22F和33F），CAPVAXIVE引发的免疫应答与PCV15和PPSV23相当，对于疫苗接种后30天通过血清型特异性OPA GMT和IgG GMC测量的CAPVAXIVE特有的八种血清型（15A，15C，16F，23A，23B，24F，31和35B）具有更高的应答；。

The proportions of participants with AEs, including injection-site, systemic, and vaccine-related AEs, were numerically lower in the V116 + placebo group than in the PCV15 + PPSV23 group.

V116+安慰剂组的AE参与者比例（包括注射部位，全身和疫苗相关AE）在数值上低于PCV15+PPSV23组。

A targeted literature review was conducted on the clinical and economic burden of pneumococcal disease in U.S. adults, with a focus on the disparities and inequities by race, geography, urbanicity, income, education and employment. Of 4,609 identified publications (published from January 2012 – July 2024), 12 studies were evaluated.

对美国成年人肺炎球菌疾病的临床和经济负担进行了有针对性的文献综述，重点是种族，地理，城市化，收入，教育和就业方面的差异和不平等。在4609份确定的出版物（2012年1月至2024年7月出版）中，对12项研究进行了评估。

Key findings showed that disparities in burden from pneumococcal disease exist in the U.S., particularly among Black adults and those living in rural areas with lower education and income. Detailed findings included:.

主要研究结果表明，美国肺炎球菌疾病的负担存在差异，尤其是黑人成年人和生活在受教育程度和收入较低的农村地区的人。详细调查结果包括：。

Black adults had the highest incidence and longest length of hospital stay due to IPD compared to other racial groups;

与其他种族相比，由于IPD，黑人成年人的发病率最高，住院时间最长；

Areas categorized as less urban displayed higher mortality rates for pneumococcal pneumonia;

被归类为城市较少的地区，肺炎球菌肺炎的死亡率较高；

Vaccination rates were lower among Black adults compared to white adults;

与白人成年人相比，黑人成年人的疫苗接种率较低；

Vaccination rates were also low among adults who lived in rural areas with lower levels of income and education.

生活在收入和教育水平较低的农村地区的成年人的疫苗接种率也很低。

The study concluded that more research is needed to further examine disparities and inequities in the burden of pneumococcal disease.

该研究得出结论，需要更多的研究来进一步检查肺炎球菌疾病负担的差异和不公平。

Results from Modeling Study Quantifying the Impact of Introducing a New Adult-Focused PCV in the United States (Abstract #P-58)

模型研究的结果量化了在美国引入新的以成人为中心的PCV的影响

A modeling study evaluated CAPVAXIVE in comparison to PCV20 to quantify the health impact of both vaccines in U.S. adults. The compartmental model captured pneumococcal carriage transmission in the presence of age- and serotype-specific pneumococcal vaccines and was calibrated to the corresponding IPD data in the U.S.

一项建模研究评估了CAPVAXIVE与PCV20的比较，以量化两种疫苗对美国成年人的健康影响。在存在年龄和血清型特异性肺炎球菌疫苗的情况下，隔室模型捕获了肺炎球菌携带传播，并根据美国相应的IPD数据进行了校准。

The model was then used to quantify the impact of both CAPVAXIVE and PCV20 on overall IPD incidence in adults of all ages, accounting for continued pediatric PCV vaccination. Analysis assumed pediatric vaccination continued at 82% coverage with an 80/20 mix of PCV20/PCV15 in infants and that 57% of adults aged 65 and older would have received a PCV in the last 10 years..

然后，该模型用于量化CAPVAXIVE和PCV20对所有年龄段成年人总体IPD发病率的影响，从而考虑到持续的儿科PCV疫苗接种。分析假设儿科疫苗接种率继续保持在82%，婴儿中PCV20/PCV15的比例为80/20，在过去10年中，65岁及以上的成年人中有57%会接受PCV。。

Results showed that while the continued use of both CAPVAXIVE and PCV20 led to reductions in IPD incidence when compared to current disease rates, the use of CAPVAXIVE led to fewer overall cases than the use of PCV20 after 10 years, with a 33.9% reduction across all ages versus a 28.9% reduction, respectively.

结果显示，与目前的疾病发病率相比，继续使用CAPVAXIVE和PCV20导致IPD发病率降低，但10年后使用CAPVAXIVE导致的总体病例比使用PCV20少，所有年龄段的病例减少33.9%，而分别减少28.9%。

These results equated to approximately 14,000 fewer cases of IPD in adults with CAPVAXIVE than with PCV20. Findings also showed that despite a greater number of cases in the serotypes not included in CAPVAXIVE when compared to adult PCV20 use, indirect protection of adults from pediatric vaccination resulted in continued declines in these serotypes from present values..

这些结果相当于成人CAPVAXIVE的IPD病例比PCV20少约14000例。研究结果还表明，尽管与成人使用PCV20相比，CAPVAXIVE中未包括的血清型病例数量更多，但对成人进行儿科疫苗接种的间接保护导致这些血清型的持续下降。。

About CAPVAXIVE

关于CAPVAXIVE

CAPVAXIVE is Merck’s approved 21-valent pneumococcal conjugate vaccine indicated for active immunization for the prevention of invasive disease and pneumonia in adults 18 years of age and older. CAPVAXIVE is specifically designed to help address

CAPVAXIVE 是默克公司批准的 21 价肺炎球菌结合疫苗，适用于主动免疫，以预防 18 岁及以上成人的侵袭性疾病和肺炎。CAPVAXIVE 专为帮助解决

Streptococcus pneumoniae

肺炎链球菌

serotypes predominantly responsible for adult invasive pneumococcal disease (IPD), including eight unique serotypes, 15A, 15C, 16F, 23A, 23B, 24F, 31 and 35B compared to other pneumococcal vaccines. CAPVAXIVE is administered as a single dose.

与其他肺炎球菌疫苗相比，主要负责成人侵袭性肺炎球菌病（IPD）的血清型包括八种独特的血清型，即15A，15C，16F，23A，23B，24F，31和35B。CAPVAXIVE以单剂量给药。

About Pneumococcal Disease

关于肺炎球菌疾病

Pneumococcal disease is an infection caused by a bacteria called

肺炎球菌病是由一种名为

Streptococcus pneumoniae

肺炎链球菌

. There are about 100 different types (referred to as serotypes) of pneumococcal bacteria, which can affect adults differently than children. Pneumococcal disease can be invasive or non-invasive. Non-invasive pneumococcal illnesses include pneumonia (when pneumococcal disease is confined to the lungs), whereas invasive pneumococcal illnesses include pneumococcal bacteremia (infection in the bloodstream), bacteremic pneumococcal pneumonia (pneumonia with bacteremia) and pneumococcal meningitis (infection of the coverings of the brain and spinal cord).

大约有100种不同类型（称为血清型）的肺炎球菌，对成年人的影响与儿童不同。肺炎球菌疾病可以是侵袭性的或非侵袭性的。非侵袭性肺炎球菌疾病包括肺炎（当肺炎球菌疾病局限于肺部时），而侵袭性肺炎球菌疾病包括肺炎球菌菌血症（血流感染），菌血症性肺炎球菌肺炎（肺炎伴菌血症）和肺炎球菌脑膜炎（感染大脑和脊髓的覆盖物）。

Pneumococcal pneumonia is a type of bacterial pneumonia, which is the most common clinical presentation of pneumococcal disease in adults. It’s estimated that over 150,000 adults are hospitalized from pneumococcal pneumonia each year in the U.S..

肺炎球菌肺炎是一种细菌性肺炎，是成人肺炎球菌疾病最常见的临床表现。据估计，美国每年有超过150000名成年人因肺炎球菌肺炎住院。

Merck’s Commitment to Pneumococcal Disease Protection

默克公司对肺炎球菌疾病保护的承诺

Merck has been at the forefront of pneumococcal disease prevention through vaccination for more than four decades and remains committed to helping to protect people of all ages from this disease. Merck’s ongoing pneumococcal vaccine development program is designed to provide options that address the specific needs of different populations, including infants and children, healthy adults and at-risk sub-groups.

40多年来，默克一直站在通过疫苗接种预防肺炎球菌疾病的最前沿，并致力于帮助保护所有年龄段的人免受这种疾病的影响。

This approach recognizes that disease burden in pediatric and adult populations is often driven by different bacterial strains, or serotypes, and aims to address unmet needs by offering vaccine options that target serotypes posing the greatest global risk to each population. To learn more about Merck’s pipeline, visit .

这种方法认识到，儿科和成人人群的疾病负担通常由不同的细菌菌株或血清型驱动，旨在通过提供针对对每个人群构成最大全球风险的血清型的疫苗选择来解决未满足的需求。

About Merck

默克

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines.

在美国和加拿大以外被称为MSD的默克公司，我们的目标是团结一致的：我们利用尖端科学的力量来拯救和改善世界各地的生活。130多年来，我们通过开发重要的药物和疫苗给人类带来了希望。

We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities.

我们立志成为世界上领先的研究密集型生物制药公司，今天，我们处于研究的前沿，以提供创新的健康解决方案，促进人类和动物疾病的预防和治疗。我们培养了一支多元化和包容性的全球劳动力队伍，并每天负责任地运作，为所有人和社区创造一个安全、可持续和健康的未来。