Japanese drugmaker Takeda Pharmaceutical Company Limited has said that its dengue vaccine candidate demonstrated protection against virologically-confirmed dengue (VCD) in children between four to 16 years.

Results from the primary endpoint analysis of the ongoing Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial of Takeda’s dengue vaccine candidate (TAK-003) were published in the New England Journal of Medicine, a note from the company said.

Dengue virus infections caused by all four serotypes were observed in the global TIDES trial. The trial will continue to assess safety and efficacy in study subjects for a total of four and a half years.

“We are excited to share this long-anticipated data from our TIDES trial, which is evaluating the performance of our dengue vaccine candidate in a diverse set of countries across Asia and Latin America, and in a study population that intentionally includes a large proportion of children who had never been exposed to dengue,” said Rajeev Venkayya, Takeda President with the Global Vaccine Business Unit.

Also read: Takeda brings drugs for 3 rare diseases to India, but pricing concerns remain

“While more data is needed to fully understand the safety and efficacy profile of TAK-003, these findings strongly suggest that it could help address the massive global burden of dengue in all populations. We look forward to sharing more data in the coming weeks, and engaging health authorities and the scientific, public health and medical communities on these findings, priorities for future evidence generation, and ways we can work together to maximise the reach and impact of this vaccine upon licensure.”

Humberto Reynales, lead author of the New England Journal of Medicine paper, said: “The results of this first analysis are very encouraging, indicating that the vaccine could potentially provide important public health benefits against dengue fever and hospitalisation.”

“It will be important to further analyse the trial results over time in order to assess the long-term efficacy and safety of the vaccine. If longer follow-up data confirm this initial observation, we are looking at a significant step forward in the global fight against dengue,” he added.

The vaccine’s efficacy was at 80.2 percent in the 12-month period after the second dose, which was administered three months after the first dose.

Similar degrees of protection were seen in individuals who had and had not been previously infected with dengue, based on planned exploratory analyses of secondary endpoints, Takeda said.

“According to the World Health Organization, dengue represents one of the ten biggest global health threats, and it is critical that we have access to a safe and effective vaccine candidate that can reduce the devastating impact dengue fever has in endemic regions,” said In-Kyu Yoon, Senior Advisor, International Vaccine Institute.

“Historically, vaccine development against dengue has been challenging, especially for people who haven’t previously been exposed to dengue, and these results demonstrate protection from dengue fever, including among many participants without prior dengue,” he added.

The trial

The double-blind, randomised, placebo-controlled Phase 3 TIDES trial is evaluating the safety and efficacy of two doses of TAK-003 in the prevention of laboratory-confirmed symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in children and adolescents.

The trial is taking place at sites in dengue-endemic areas in Latin America (Brazil, Colombia, Panama, Dominican Republic and Nicaragua) and Asia (Philippines, Thailand and Sri Lanka), where there are unmet needs in dengue prevention and where severe dengue is a leading cause of serious illness and death among children.

Both the primary endpoint analysis and formal assessment of secondary endpoints will be presented at the American Society of Tropical Medicine and Hygiene’s 68th Annual Meeting (November 20-24, 2019).

Related Topics