默克公司启动评估登革热疫苗候选物的第三阶段研究-动脉网

Merck Initiates Phase 3 Study Evaluating Dengue Vaccine Candidate

默沙东等信源发布 2025-06-12 11:21

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June 12, 2025 6:45 am ET

2025年6月12日上午6点45分（美国东部时间）

MOBILIZE-1 is the first Phase 3 study being initiated for V181 as part of a planned robust clinical development program

MOBILIZE-1 是 V181 作为计划中的强大临床开发项目的一部分而启动的首个第 3 阶段研究

Study will evaluate a single dose of V181 for the prevention of dengue disease caused by any of the four serotypes of the dengue virus regardless of previous exposure

研究将评估单剂量V181预防由四种登革病毒血清型中任何一种引起的登革热疾病的效果，无论以前是否接触过。

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

新泽西州拉威市--(BUSINESS WIRE)--

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of the MOBILIZE-1 Phase 3 clinical trial evaluating the safety, immunogenicity and efficacy of a single dose of V181, an investigational quadrivalent vaccine, for the prevention of dengue disease caused by any of the four dengue virus serotypes (DENV-1, DENV-2, DENV-3, and DENV-4), regardless of prior dengue exposure.

默克公司（纽约证券交易所代码：MRK），在美国和加拿大以外地区称为MSD，今天宣布启动MOBILIZE-1第三阶段临床试验，评估在研四价疫苗V181单剂量的安全性、免疫原性和有效性，用于预防由四种登革病毒血清型（DENV-1、DENV-2、DENV-3 和 DENV-4）引起的登革热疾病，无论既往是否接触过登革热。

Recruitment for the trial has begun, and the first participants are now enrolling in Singapore..

试验的招募工作已经开始，首批参与者正在新加坡注册。

“Approximately half of the world’s population live in areas with a risk for dengue, making it a serious public health threat,” said Dr. Paula Annunziato, senior vice president, infectious diseases and vaccines, global clinical development, Merck Research Laboratories. “The initiation of the MOBILIZE-1 study, the first Phase 3 trial in our clinical development program, marks a key milestone in our work to help address this widespread mosquito-borne disease.

“大约一半的全球人口生活在有登革热风险的地区，这使得它成为严重的公共卫生威胁，”默克研究实验室传染病与疫苗部门高级副总裁、全球临床开发主管宝拉·安祖齐奥博士表示。“MOBILIZE-1 研究的启动是我们临床开发项目中的首个 III 期试验，这标志着我们在应对这一广泛传播的蚊媒疾病的工作中迈出了关键一步。”

If successful, V181 could provide an important single-dose option for at risk populations, regardless of previous exposure to dengue, to help reduce the significant burden around the globe.”.

如果取得成功，V181 可以为风险人群提供一种重要的单剂量选择，无论其之前是否接触过登革热，从而有助于减轻全球的重大负担。"

Merck is committed to research and innovation that aims to help protect the millions of people at risk for dengue virus infection and is establishing a program of clinical trials for V181, including conducting trials globally, in places where dengue is a significant health threat.

默克致力于研究和创新，旨在帮助保护数百万面临登革病毒风险的人，并正在开展V181的临床试验计划，包括在全球登革热构成重大健康威胁的地方进行试验。

About MOBILIZE-1 (

关于MOBILIZE-1 (

NCT07013487

)

MOBILIZE-1, also known as V181-005, is a Phase 3, randomized, double-blind, placebo-controlled study evaluating the safety, immunogenicity and efficacy of V181, an investigational vaccine for the prevention of dengue disease. The study aims to enroll approximately 12,000 healthy individuals 2 to 17 years of age who will be randomized to receive either a single dose of V181 or placebo.

MOBILIZE-1，亦称为V181-005，是一项III期随机、双盲、安慰剂对照研究，旨在评估V181（一种预防登革热的在研疫苗）的安全性、免疫原性和有效性。该研究计划招募约12,000名2至17岁的健康个体，这些个体将被随机分配接受单剂V181疫苗或安慰剂。

The study is planned to include more than 30 trial sites in dengue endemic areas in the Asia-Pacific region, including Indonesia, Malaysia, Philippines, Singapore, Thailand and Vietnam. The primary endpoints of the study are safety and efficacy of a single dose of V181 in preventing symptomatic virologically confirmed dengue (VCD) of any severity, due to any of the four dengue serotypes, regardless of prior dengue exposure.

该研究计划在亚太地区的登革热流行区域设立超过30个试验点，包括印度尼西亚、马来西亚、菲律宾、新加坡、泰国和越南。研究的主要终点是单剂量V181在预防任何严重程度的、由四种登革病毒血清型中任何一种引起的、经病毒学确认的症状性登革热（VCD）方面的安全性和有效性，无论之前是否有登革热暴露史。

The key secondary efficacy endpoint is evaluating a single dose of V181 in preventing symptomatic VCD of any severity due to each of the four dengue serotypes, regardless of prior dengue exposure. Additional secondary endpoints include evaluating a single dose of V181 in preventing symptomatic VCD with warning signs, severe VCD and hospitalization..

次要疗效终点是评估单剂量 V181 在预防因四种登革病毒血清型引起的任何严重程度的症状性 VCD 方面的效果，无论既往是否有登革热暴露史。其他次要终点包括评估单剂量 V181 在预防有警示症状的症状性 VCD、严重 VCD 和住院方面的效果。

For more information on the trial, visit

有关试验的更多信息，请访问

clinicaltrials.gov

临床试验.gov

。

About V181

关于V181

V181 is a live attenuated quadrivalent vaccine currently being investigated for the prevention of dengue disease caused by any of the four dengue virus types (DENV-1, DENV-2, DENV-3, and DENV-4). V181 is designed to be a single-dose vaccination and is being studied in individuals to provide protection against dengue, including severe forms, whether the individuals have been previously infected with the dengue virus or had no prior infections..

V181 是一种减毒四价疫苗，目前正在研究用于预防由四种登革病毒类型（DENV-1、DENV-2、DENV-3 和 DENV-4）引起的登革热疾病。V181 设计为单剂量接种，并正在研究为个人提供针对登革热（包括严重形式）的保护，无论个人是否曾感染过登革病毒或之前未感染过。

About Dengue disease

关于登革热疾病

Dengue disease is one of the fastest growing mosquito-borne diseases that affects not just the health but often the economic stability of communities across the globe. It is a rapidly emerging cause of serious and sometimes debilitating illness in tropical and subtropical countries. With approximately half of the world’s population, or four billion people, at risk for dengue disease, it represents a critical public health challenge.

登革热是传播最快的蚊媒疾病之一，它不仅影响健康，而且常常影响全球各社区的经济稳定。它是热带和亚热带国家严重疾病和有时导致虚弱疾病的迅速出现的原因。大约一半的世界人口，即四十亿人，面临登革热的威胁，这使其成为一项关键的公共卫生挑战。

Globally, around 105 million dengue viral infections occur annually, with approximately 50-60 million being symptomatic on average per year. While the majority of infections are uncomplicated, serious illness caused by dengue can be severe and lead to death (on average, ~4-11 million cases result in hospitalizations per year and there is an average annual incidence of ~29,000 dengue-related deaths worldwide).

全球范围内，每年大约发生1.05亿例登革病毒的感染，其中约有5000万至6000万例为有症状感染。尽管大多数感染并不复杂，但由登革热引发的严重疾病可能会非常严重并导致死亡（平均每年约有400万至1100万例感染需要住院治疗，并且全球每年平均因登革热相关原因导致约29,000人死亡）。

Symptoms of mild dengue fever may include a high fever, a rash and muscle and joint pain. Dengue fever might evolve to severe dengue, formerly known as dengue hemorrhagic fever, which can cause severe bleeding, a sudden drop in blood pressure, and in rare cases, death..

轻度登革热的症状可能包括高烧、皮疹以及肌肉和关节疼痛。登革热可能发展为重症登革热，以前称为登革出血热，这可能会导致严重出血、血压骤降，并在极少数情况下导致死亡。

About Merck

关于默克

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地区称为默沙东的默克公司，我们团结一致，致力于我们的使命：利用前沿科学的力量拯救和改善世界各地的生命。130多年来，我们通过开发重要的药物和疫苗为人类带来希望。

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.

我们立志成为全球首屈一指的研究密集型生物制药公司——今天，我们站在研究的最前沿，提供创新的健康解决方案，推动人类和动物疾病预防与治疗的进步。我们培养多元化和包容性的全球员工队伍，并每天负责任地运营，以确保为所有人和社区创造一个安全、可持续和健康的未来。

For more information, visit .

欲了解更多信息，请访问。

www.merck.com

and connect with us on

并关注我们

X (formerly Twitter)

X（前称Twitter）

，

Facebook

，

Instagram

，

YouTube

and

和

领英

。

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

美国新泽西州拉威市默克公司前瞻性声明

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties.

本新闻稿由美国新泽西州拉威市的默克公司（Merck & Co., Inc.，以下简称“公司”）发布，包含根据1995年美国私人证券诉讼改革法案安全港条款定义的“前瞻性声明”。这些声明基于公司管理层的当前信念和预期，并受到重大风险和不确定性的约束。

There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements..

对于管线候选产品，无法保证这些候选产品会获得必要的监管批准或证明其商业上的成功。如果基本假设被证明不准确或风险和不确定性变为现实，实际结果可能与前瞻性声明中所述的结果存在重大差异。

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions..

风险和不确定性包括但不限于：行业普遍状况和竞争；普遍经济因素，包括利率和汇率波动；美国及国际制药行业监管和医疗保健立法的影响；全球医疗成本控制趋势；技术进步、竞争对手获得的新产品和专利；新产品开发中固有的挑战，包括获得监管批准；公司准确预测未来市场状况的能力；生产困难或延误；国际经济的财务不稳定性和主权风险；对创新产品依赖于公司专利及其他保护的有效性；以及面临诉讼（包括专利诉讼）和/或监管行动的风险。

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (.

公司不承担公开更新任何前瞻性声明的义务，无论这是由于新信息、未来事件或其他原因。可能导致结果与前瞻性声明中描述的情况有重大差异的其他因素，可参见公司截至2024年12月31日年度的10-K表格年报以及公司向证券交易委员会（SEC）提交的其他文件，这些文件可在SEC的官方网站上查阅。

www.sec.gov

Media Contacts:

媒体联系人：

Olivia Finucane

奥利维亚·菲努凯恩

0044 7881 262476

olivia.finucane@msd.com

奥利维亚.菲努卡内@msd.com

Kimberly Petrillo

金伯利·佩特里洛

(267) 742-2813