On May 24, Takeda Pharmaceutical Company Limited announced the 3-year follow-up results from the global Phase 3 clinical trial (TIDES) of its dengue vaccine, TAK-003. The data showed that despite a decline in vaccine efficacy over time, TAK-003 maintained an efficacy rate of 62.0% in preventing dengue infection.
Dengue fever, commonly known as "breakbone fever," is the fastest-spreading mosquito-borne viral disease, capable of infecting people of all ages, and was listed by the World Health Organization (WHO) as one of the top ten threats to global health in 2019. It is estimated that globally, dengue causes 390 million infections and approximately 20,000 deaths annually, making it a leading cause of severe illness among children in some countries in Latin America and Asia.
TAK-003 is a live-attenuated tetravalent dengue vaccine developed based on an attenuated dengue virus serotype 2 (DENV-2), which provides the genetic backbone for all four vaccine viruses. In Phase 1 and Phase 2 clinical trials, vaccinated adolescents elicited immune responses to all four dengue viruses, demonstrating favorable safety and tolerability.
TIDES is a 4.5-year randomized, double-blind, placebo-controlled pivotal trial designed to evaluate the preventive efficacy of TAK-003 in children aged 4 to 16 years with and without prior dengue exposure. The study enrolled over 20,000 healthy children and adolescents across dengue-endemic regions in Latin America and Asia.
Previous data indicated that at months 12 and 18 following completion of the two-dose vaccination regimen, the overall vaccine efficacy against dengue infection in participants was 80.2% and 73.3%, respectively.
Takeda announced data from 36 months after participants received two doses of the vaccine, showing that the overall efficacy of TAK-003 was 62.0% (95% CI: 56.6% to 66.7%), with an efficacy against hospitalization of 83.6% (95% CI: 76.8% to 88.4%). Additionally, TAK-003 was generally well-tolerated, with no significant safety risks observed.
Derek Wallace, Vice President and Head of the Global Dengue Program at Takeda, said: "Our dengue candidate vaccine provides durable protection against dengue infection over three years and is particularly effective in preventing hospitalization. These results further strengthen my confidence that TAK-003 can help address the substantial global burden of dengue."
References:
[1] Takeda Official Website
[2]https://www.fiercebiotech.com/biotech/takeda-s-dengue-shot-keeps-84-kids-out-hospital-regardless-prior-infection-giving-it-a-leg