Merck begins Phase 3 study for Dengue vaccine candidate
Merck is establishing a program of clinical trials for V181, including conducting trials globally, in places where dengue is a significant health threat.
Rahway: Merck, known as MSD outside of the United States and Canada, has 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 establishing a program of clinical trials for V181, including conducting trials globally, in places where dengue is a significant health threat.
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.
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.
