Takeda Announced 3-Year Phase III Trials Data of Dengue Vaccine TAK-003

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Dengue vaccine! Takeda announced the three-year long-term data of the attenuated quadrivalent vaccine TAK-003 Phase III clinical trials: long-term protection and good safety!

Takeda Announced 3-Year Phase III Trials Data of Dengue Vaccine TAK-003 .  Takeda Pharmaceuticals (Takeda) recently announced that data from the ongoing key phase 3 TIDES trial of dengue vaccine TAK-003 shows that TAK-003 is a vaccine within 3 years after vaccination The vaccinators provide durable protection against dengue fever disease and hospitalization, regardless of whether they have been previously exposed to dengue fever.

Specifically, during the 3 years after vaccination, TAK-003 prevented 83.6% of hospitalizations and 62.0% of dengue fever diseases, and no major safety risks were found.

The TIDES trial recruited more than 20,000 healthy children and adolescents between the ages of 4-16 in countries where dengue fever is prevalent in Latin America and Asia.

An exploratory analysis of the 36-month follow-up of the trial yielded safety and efficacy results. Within 3 years (36 months after the second dose), the overall vaccine efficacy (VE) of TAK-003 against virologically confirmed dengue fever (VCD) was 62.0% (95% CI: 56.6%-66.7%), seropositivity Among individuals, it was 65.0% (95% CI: 58.9%-70.1%), and among seronegative individuals, it was 54.3% (95% CI: 41.9%-64.1%).

The VE of TAK-003 against hospitalized dengue fever was 83.6% (95% CI: 76.8%-88.4%), 86.0% (95% CI: 78.4%-91.0%) in seropositive individuals, and 77.1% in seronegative individuals ( 95%CI: 58.6%-87.3%).

The observation results of the difference of different serotypes of VE are consistent with the previously reported results. No signs of exacerbation of the disease were observed. TAK-003 is generally well tolerated, and no important safety risks have been observed.

This result strengthens the potential of TAK-003 and helps protect those who live in or travel to dengue-endemic countries.

As mentioned earlier, the TIDES trial reached the overall VE primary endpoint for VCD (VE: 80.2%; 95% CI: 73.3%-85.3%; p<0.001) and sufficient numbers of dengue fever cases were available for analysis during the 12-month follow-up All secondary endpoints (measured at 18 months of follow-up). The TIDES trial has been revised to include assessment of booster doses to address the overall reduction in VE observed over time (from 12 months to 36 months after the second vaccination), which mainly exists in outpatient dengue fever patients in. The results of the 36-month exploratory analysis of the trial will be published in a peer-reviewed journal this year.

LakKumar Fernandoi, the lead researcher of the TIDES trial and the Clinical Management Center for Dengue Fever and Dengue Haemorrhagic Fever, Negombo General Hospital, Sri Lanka, said: “The sudden outbreak of dengue fever may cause the hospital to be overwhelmed by the large number of severe disease cases and people seeking testing. TAK The results of the long-term analysis of the -003 vaccine show that the vaccine can help prevent outbreaks, reduce hospitalization rates, and protect people from dengue infection, regardless of whether they have been exposed to dengue before. Importantly, no major safety risks have been identified.”

Derek Wallace, Takeda Dengue Global Program Leader and Vice President, said: “Our dengue vaccine candidate continues to provide durable protection against dengue for the entire 3 years and is particularly effective in preventing hospitalization. These results have strengthened my confidence, namely TAK- 003 helps to solve the major burden of global dengue fever.”

TAK-003 is an attenuated quadrivalent dengue vaccine, developed based on the attenuated dengue serotype 2 virus (DENV-2), which provides a genetic backbone for all four vaccine viruses. Data from a phase II clinical study in children and adolescents shows that TAK-003 induces neutralizing antibodies against four serotypes of dengue virus across all age groups and in seropositive individuals and serology negative individuals. Simultaneous vaccine The safety and well tolerated.

The key phase 3 TIDES trial reached the primary endpoint of vaccine efficacy (VE) against virologically proven dengue fever (VCD) at 12 months of follow-up, and reached all secondary endpoints at 18 months of follow-up, including for hospitalization Dengue VE, VE in baseline seropositive and baseline seronegative individuals. The VE of TAK-003 varies by serotype. The results of the study show that TAK-003 is well tolerated and no major safety risks have been observed so far.

In April this year, the European Medicines Agency (EMA) has accepted the application documents for TAK-003, the vaccine developed for people aged 4-60 to prevent dengue fever (dengue) caused by any dengue virus serotype.

The safety and efficacy data during the 36-month follow-up period of the TIDES trial has been included in regulatory documents submitted to the European Union and dengue-endemic countries, and will become part of other regulatory documents scheduled to be submitted in 2021, including in the United States. Takeda will seek indications for TAK-003 to prevent dengue fever among people aged 4-60 based on data from adults and children, regardless of whether they were previously exposed to dengue fever. Currently, there is still a need for a dengue vaccine that can be used for both adults and children who have not been exposed to dengue-naive and dengue-exposed.

Dengvaxia: The world’s first dengue vaccine, produced by Sanofi

At present, there is only one dengue vaccine product on the market in the world, that is, Dengvaxia, a vaccine product developed by the French pharmaceutical giant Sanofi over 20 years. The vaccine was approved by Mexico in December 2015, becoming the first approved vaccine in the world. A dengue vaccine product. Since then, the vaccine has been approved by many dengue-endemic countries in Latin America and Asia, and it was approved by the European Union in December 2018. In the United States, Dengvaxia was approved by the FDA in May 2019, becoming the first medical preventive tool for dengue fever in the U.S. market.

Dengue fever (Dengue) is an acute vector-borne disease caused by the transmission of dengue virus through mosquitoes. Clinical manifestations include high fever, headache, severe aches and pains in muscles and bones and joints, skin rash, bleeding tendency, lymphadenopathy, decreased white blood cell count, thrombocytopenia, etc. Dengue fever is one of the main causes of death in children in Southeast Asia.

Dengue fever, commonly known as “breakbone fever”, is the fastest-spreading mosquito-borne viral disease and is one of the top ten global health threats to the World Health Organization (WHO) in 2019. Dengue fever is mainly transmitted by Aedes aegypti, followed by Aedes albopictus. It is caused by any of the 4 dengue virus serotypes, each of which can cause dengue fever or severe dengue fever. Different geography, countries, regions, seasons, and over time, the prevalence of individual serotypes is also different. Recovering from an infection of a serotype only produces life-long immunity to that serotype, and subsequent exposure to any other serotype will increase the risk of serious diseases.

Dengue fever is easily endemic, with outbreaks in tropical and subtropical regions, and recently also caused outbreaks in the continental United States and parts of Europe. About half of the world’s population is now under the threat of dengue fever. It is estimated that globally, dengue fever will cause 390 million infections and approximately 20,000 deaths each year. Dengue virus can infect people of all ages and is the leading cause of serious illnesses in children in some countries in Latin America and Asia.

Currently, there is no targeted treatment for dengue hemorrhagic fever. Dengue fever is caused by 4 different serotypes of dengue virus, and there is no immune effect between the virus strains, so it can be reinfected by different serotypes of dengue virus.

(source:internet, reference only)

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