Latest news with #V181
Straits Times
20-07-2025
- Health
- Straits Times
Trial of new dengue vaccine begins recruitment for child participants in Singapore
Find out what's new on ST website and app. The study's lead investigator in Singapore, Assistant Professor Chia Po Ying (left), and Dr Zhong Youjia, another investigator on the study. SINGAPORE – A phase three clinical trial is being conducted here to evaluate the safety and efficacy of a new quadrivalent dengue vaccine in children aged two to 17. Developed by US-based pharmaceutical firm MSD, V181 is a single-dose vaccine that aims to provide protection against all four serotypes, or strains, of the dengue virus. Phase three clinical trials are typically the last stage of testing before a drug's details and clinical trial results are submitted to the regulatory authorities for approval. The study's lead investigator in Singapore, Assistant Professor Chia Po Ying, noted that V181 is a live-attenuated vaccine, which uses weakened versions of all four dengue serotypes. 'Using the weakened forms of all these four dengue serotypes stimulates a human immune response to create protection against dengue infection in future,' said Prof Chia, who also heads the National Centre for Infectious Diseases Research Office. The new study here hopes to recruit at least 700 healthy children between the ages of two and 17, including both those who have previously contracted dengue and those who have never had the disease, said Dr Zhong Youjia, another investigator on the study. This particular study focuses on children as they are more vulnerable to dengue and are also at a greater risk of severe infection, said the associate consultant at National University Hospital's (NUH) Khoo Teck Puat – National University Children's Medical Institute. Side effects from the vaccine have been mild and short-lived, said Prof Chia, noting that they include muscle aches and fatigue. Children enrolled in the study will be randomly chosen to get a single shot of either the vaccine or a placebo. 'There have been no serious adverse events linked to vaccination with V181 to date, and the previous trials actually have shown a very good and favourable safety profile,' Prof Chia said. In Singapore, the study is being conducted at NUH and Tan Tock Seng Hospital, which have already started recruiting participants. Only a handful of children have been recruited so far for the study here, which began in June, said Dr Zhong. A third recruitment site, KK Women's and Children's Hospital, is also in the works. As at July 12, there have been 2,816 dengue cases recorded here in 2025, according to figures from the National Environment Agency (NEA). In May, NEA noted that the number of dengue cases recorded here between January and May 2025 has dropped by about 74 per cent from the same period in 2024. Worldwide, the study aims to enrol about 12,000 healthy children, also between the ages of two and 17, who will receive either a single dose of V181 or a placebo. It aims to include more than 30 trial sites in dengue endemic areas in the Asia-Pacific, including Indonesia, Malaysia and the Philippines. Developing effective dengue vaccines has been difficult as the four serotypes are effectively four different viruses, said Prof Chia. While getting infected by one serotype grants lifelong protection against that particular strain, it provides only short-term protection against the other three, she said. This short-term protection eventually wanes, she noted, adding that those who contract dengue more than once risk antibody-dependent enhancement – a phenomenon where antibodies that are generated due to a vaccine or prior infection actually increase the severity of an infection. Dr Zhong noted this can result in dengue shock syndrome, otherwise known as dengue haemorrhagic fever, a potentially life-threatening complication with symptoms including circulatory failure. Designing a dengue vaccine has been challenging as it has to take into account this phenomenon, Prof Chia said. Should the trials be successful and the vaccine meet regulatory requirements, V181 could be commercially available as early as within the next three to five years, said Dr Zhong. Dr Paula Annunziato, senior vice-president for infectious diseases and vaccines global clinical development at MSD Research Laboratories, noted that half the world's population live in areas at risk for dengue. '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,' she said. Dengvaxia, developed by Sanofi Pasteur, is currently the only dengue vaccine approved for use in Singapore. However, it is available only for those between 12 and 45 years old who have previously been infected and poses an increased risk of causing severe dengue in those who have never been infected. In May 2024, another quadrivalent vaccine, Qdenga, received pre-qualification from the World Health Organisation (WHO) – a process that aims to ensure the safety and efficacy of treatments – with WHO recommending the vaccine's use for children aged between six and 16 in dengue-prone areas. Developed by Japanese pharmaceutical company Takeda, Qdenga was made available in Malaysia in June 2024 . Qdenga was submitted for approval here in 2022. However, the following year, the Health Sciences Authority said Takeda had withdrawn its application. The authority said then that the company could submit another application with further clinical data on the vaccine meeting the 'required safety, efficacy and quality standards for use locally'.
Yahoo
16-06-2025
- Health
- Yahoo
MSD begins Phase III trial of dengue vaccine
Merck & Co (MSD) has initiated the randomised MOBILIZE-1 Phase III trial to assess the immunogenicity, efficacy, and safety of the investigational quadrivalent vaccine, V181, designed to prevent dengue disease. The disease is caused by any of the four serotypes: DENV-1, DENV-2, DENV-3, and DENV-4. Also referred to as V181-005, the study has started enrolling its first subjects in Singapore. The placebo-controlled, double-blind trial aims to enrol approximately 12,000 healthy individuals aged two to 17 years old. They will be randomised and given either a single dose of the vaccine or a placebo. More than 30 trial sites across dengue endemic regions in the Asia-Pacific, including Indonesia, the Philippines, Singapore, Thailand and Vietnam, are planned to be part of the trial. The trial's primary goal is to determine the efficacy and safety of a single dose of the vaccine in preventing symptomatic virologically confirmed dengue (VCD) of any severity, caused by any dengue serotype, and without consideration of previous dengue exposure. A key secondary efficacy endpoint is the evaluation of V181's ability to prevent symptomatic VCD caused by each serotype. Additional secondary goals of the trial include the assessment of V181 in preventing symptomatic VCD with severe VCD, warning signs, and hospitalisation due to dengue. The live attenuated quadrivalent vaccine is intended to be administered in one dose. MSD Research Laboratories' global clinical development infectious diseases and vaccines senior vice-president Dr Paula Annunziato said: 'Approximately half of the world's population lives in areas with a risk for dengue, making it a serious public health threat. 'The initiation of the MOBILIZE-1 study, the first Phase III trial in our clinical development programme, marks a key milestone in our work to help address this widespread mosquito-borne disease. '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.' MSD's investigational KRAS G12C inhibitor has recently shown signs of anti-tumour activity when used both alone and in combination with other oncology drugs. "MSD begins Phase III trial of dengue vaccine" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
16-06-2025
- Health
- Yahoo
Merck Initiates Phase 3 Study Evaluating Dengue Vaccine Candidate
MOBILIZE-1 is the first Phase 3 study being initiated for V181 as part of a planned robust clinical development program 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 RAHWAY, N.J., June 12, 2025--(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. Recruitment for the trial has begun, and the first participants are now enrolling in Singapore. "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. 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." 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. About 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. 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. 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. For more information on the trial, visit About V181V181 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. About Dengue diseaseDengue 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. 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). 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. About MerckAt 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. 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. For more information, visit and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USAThis 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. 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. 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. 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 ( View source version on Contacts Media Contacts:Olivia Finucane0044 7881 Kimberly Petrillo(267) 742-2813kimberly_petrillo@ Investor Contacts:Peter Dannenbaum(732) Damini Chokshi(732) Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
12-06-2025
- Health
- Business Wire
Merck Initiates Phase 3 Study Evaluating Dengue Vaccine Candidate
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. Recruitment for the trial has begun, and the first participants are now enrolling in Singapore. '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. 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.' 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. About 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. 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. 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. For more information on the trial, visit About 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. About Dengue disease 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. 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). 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. About Merck 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. 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. For more information, visit and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA 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. 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. 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. 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 (
