Experimental dengue vaccine provides immunity for over four years

June 16, 2022

A dengue vaccine candidate developed by Takeda Pharmaceutical (Takeda), TAK-003, has shown promising results in a Phase 3 trial, providing continued protection against dengue fever through 4.5 years (54 months) post-vaccination. Data revealed TAK-003 prevented 61% of symptomatic dengue cases and 84% of hospitalised cases with no important safety risks identified in a trial known as TIDES (Tetravalent Immunisation against Dengue Efficacy Study).

The TIDES trial is Takeda’s largest interventional clinical trial to date, enrolling more than 20,000 healthy children and adolescents four to 16 years of age, across eight dengue-endemic countries, over the past four and a half years.

Dengue is a fast-spreading viral disease, mainly spread by Aedes aegypti mosquitoes. The virus can infect anyone, causing dengue fever or severe dengue. Recovery from infection by one of four dengue virus serotypes provides lifelong immunity against only that serotype, and later exposure to any of the remaining serotypes might be associated with an increased risk of severe disease. The prevalence of each individual serotype varies across different geographies, countries, regions, seasons, and time.

Dengue outbreaks are commonly observed in tropical and sub-tropical areas – Asia Pacific is highly susceptible to the threat of dengue. Singapore is one of the countries affected and has recorded a high number of cases over the past few months, even before traditional peak dengue season from June to October. As of end-May, there are 398 active dengue clusters, with 103 clusters containing 10 or more cases.

In addition, population of the Aedes aegypti mosquito is 22% higher compared to the same period last year, exacerbating the dengue situation in Singapore while putting pressure on its healthcare systems.

Fortunately, the positive 54-month TAK-003 data suggests a new era of dengue management is within reach. TAK-003 is able to mitigate the impacts of dengue and reduce hospitalisation rates regardless of previous dengue infection, said Professor Duane Gubler, Emeritus Professor and Founding Director of the Emerging Infectious Diseases (EID) Signature Research Programme at Duke-NUS Medical School in Singapore.

Professor Gubler has noted, however, that to achieve optimal results with the vaccine, it should be integrated with existing Aedes Aegypti mosquito control efforts.

“Singapore continues to place effective dengue management at the forefront of its efforts with multiple vector control strategies in place, such as the use of Wolbachia mosquitos and regular fumigation of public areas. Prioritisation of personal responsibility has also played a role in ensuring home environments are free from Aedes Aegypti mosquitos,” said Dr. Ellyana Ismail, Head of Medical Affairs, Malaysia and Singapore, Takeda. “With demonstrated efficacy and safety of the TAK-003 vaccine candidate, we are excited to support ongoing efforts and provide those living in Singapore and the broader ASEAN region with an integrated solution to manage dengue following its approval.”

“Dengue is estimated to cause the region an annual economic burden of US$950 million and a global burden of almost US$9 billion, with 40% being from decreased productivity,” according to Thomas Willemsen, Senior Vice President of Takeda Pharmaceuticals (Asia Pacific). “Takeda’s investments in vaccines support our ambitions to bring TAK-003 to people who can potentially benefit from it. The TIDES trial was designed to account for both dengue-naïve and dengue-exposed populations in Asia and Latin America where outbreaks are prevalent, for over four and a half years, and we are proud that the results continue to demonstrate the safety and efficacy of the vaccine and its ability to provide long-term protection against dengue.”

The TIDES trial remains ongoing to evaluate the safety and efficacy of a booster dose. Meanwhile, TAK-003 is also undergoing regulatory review for the prevention of dengue disease in children and adults in the European Union and selected dengue-endemic countries.

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