Dengue Vaccine Trial Begins in Asia-Pacific
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Phase 3 study assesses single-dose vaccine’s effectiveness against all four dengue serotypes.
SINGAPORE – A phase 3 clinical trial, named Mobilize-1, has commenced to evaluate the safety, immunogenicity, and efficacy of a single-dose quadrivalent dengue vaccine, V181, in preventing dengue fever caused by all four serotypes of the dengue virus (DENV-1, DENV-2, DENV-3, and DENV-4). The study, sponsored by MERCK, aims to enroll participants regardless of prior dengue exposure.
Recruitment has begun, with the first participants being enrolled in SINGAPORE. The trial is part of a broader clinical program for V181, which includes studies in regions where dengue poses a significant public health threat.
Mobilize-1 Trial Details
The Mobilize-1 study (NCT07013487),also known as V181-005,is a randomized,double-blind,placebo-controlled phase 3 trial designed to assess the V181 vaccine’s ability to prevent dengue. The study plans to include approximately 12,000 healthy individuals aged 2 to 17 years, who will be randomly assigned to receive either a single dose of V181 or a placebo.
The study plans to include approximately 12,000 healthy individuals aged 2 to 17 years.
The trial will be conducted at over 30 sites in dengue-endemic areas within the Asian-Pacific region, including INDONESIA, MALAYSIA, the PHILIPPINES, SINGAPORE, THAILAND, and VIETNAM.
Study Endpoints and Vaccine Information
The primary goals of the study are to determine the safety and effectiveness of a single dose of V181 in preventing symptomatic, virologically confirmed dengue (VCD) of any severity caused by any of the four dengue serotypes, irrespective of previous dengue exposure. A key secondary endpoint is evaluating V181’s ability to prevent symptomatic VCD of any severity caused by the four serotypes,regardless of prior exposure.
Additional secondary endpoints include assessing V181’s effectiveness in preventing symptomatic VCD with warning signs, severe VCD, and hospitalizations.
V181 is an attenuated quadrivalent live vaccine being investigated for its potential to prevent dengue caused by the four dengue virus serotypes. It is indeed designed as a single-dose vaccine intended to provide protection against dengue fever, including severe forms, regardless of previous infection.
About Dengue Fever
Dengue fever is a mosquito-borne viral disease that is rapidly spreading and impacting both public health and economic stability worldwide. It is a leading cause of severe illness and death in tropical and subtropical regions.
Frequently Asked Questions About Dengue Fever
What are the symptoms of dengue fever?
Symptoms of dengue fever can include high fever, rash, muscle and joint pain. Severe dengue can lead to bleeding, a sudden drop in blood pressure, and in rare cases, death.
How is dengue fever transmitted?
Dengue fever is transmitted to humans through the bite of infected Aedes mosquitoes.
Is ther a vaccine for dengue fever?
Yes, there are dengue vaccines available. The V181 vaccine is currently in phase 3 clinical trials to assess its safety and effectiveness.
Approximately half of the world’s population, around four billion people, are at risk of dengue. Each year, there are an estimated 100 to 400 million dengue virus infections, with an average of 50 to 60 million symptomatic cases.
While most infections are mild, severe dengue can be life-threatening. Symptoms of mild dengue include high fever, rash, and muscle and joint pain. Severe dengue can cause severe bleeding, a sudden drop in blood pressure, and, in rare cases, death.
