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.
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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.
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By GlobalDataA 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.
