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Takeda Pharmaceutical Co. said Tuesday that its experimental dengue vaccine appeared to be safe and effective in preventing all four types of mosquito-borne disease, which is the main goal of the Japanese manufacturer's advanced clinical trial. drugs.
The company said that no major safety concerns have been raised to date with the vaccine called TAK-003.
Takeda did not disclose how the vaccine had been administered to people who had never been previously exposed to dengue, a group exposed to an increased risk of serious illness badociated with Sanofi dengvaxia, the first the world's vaccine against dengue.
Sanofi had not taken any blood samples on all subjects before the start of the tests. When the company confirmed the safety risk in 2017, the vaccine had already been used by more than 800,000 schoolchildren in the Philippines.
Takeda took blood samples from the 20,000 children in Asia and Latin America aged 4 to 16 who participated in the TIDES Phase III trial. The study examined the safety and effectiveness of the vaccine in children exposed to dengue fever and others.
Takeda said he would publish the details of the vaccine's reaction as soon as possible 15 months after the first dose in a peer-reviewed journal.
The vaccine is given in two separate doses of three months. The first results of effectiveness include 11 months of follow-up.
The second part of the trial, which includes an additional six months of patient data, will review the performance of the vaccine in each of the four types of dengue fever, as well as its performance based on previous exposure. dengue fever and the number of participants who contracted severe dengue fever. .
These two parts will form the basis of Takeda's filings for regulatory approvals. A third part of the study will badess long-term safety by following participants for another three years.
Dr. Rajeev Venkayya, president of Takeda's vaccines division, said in a telephone interview that the next publication would include preliminary data on vaccine performance against each strain of dengue fever and data on exposure previous dengue subjects.
The first safety problems of Sanofi vaccine did not appear until the third year after vaccination. After Sanofi's experience, some experts believe that governments will need several years of follow-up data before integrating Takeda's vaccine into mbad vaccination campaigns.
Venkayya does not speculate on the number of follow ups required by regulators or health authorities, but adds: "I think it will be more than a year."
Sanofi's vaccine was based on a yellow fever virus to which dengue genes were added, while TAK-003 is based on a weakened dengue 2 virus and genes from the other three types of dengue fever. Some infectious disease experts believe that 100% dengue design could trigger a broader immune response.
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