Potential Impact of Takeda’s Dengue Vaccine Candidate Reinforced by Long-Term Safety and Efficacy Results
Takeda Pharmaceutical Company
Limited (TSE:4502/NYSE:TAK) (“Takeda”) announced that its
dengue vaccine candidate (TAK-003) demonstrated continued protection against
dengue illness and hospitalization, regardless of an individual’s previous
dengue exposure, with no important safety risks identified through three years
after vaccination in the ongoing pivotal Phase 3 Tetravalent Immunization
against Dengue Efficacy Study (TIDES) trial. TIDES enrolled more than 20,000
healthy children and adolescents ages four to 16 years in dengue-endemic
countries in Latin America and Asia.
“Dengue epidemics occur suddenly,
and hospitals can become overwhelmed with severe disease cases and people
seeking testing,” said LakKumar Fernandoi, M.D., Center
for Clinical Management of Dengue and Dengue Haemorrhagic Fever, Negombo
General Hospital, Sri Lanka and a primary investigator of the TIDES trial.
“Results from the long-term analysis of Takeda’s dengue vaccine candidate
suggest that it could help with outbreak prevention, reduce rates of
hospitalization and protect people from dengue regardless of their previous
exposure. Importantly, no important safety risks were identified.”
Safety and efficacy results from the 36-month follow-up exploratory
analysis of TIDES were presented on May 22, 2021, at the 17th Conference of the
International Society of Travel Medicine (CISTM). Through three years (36
months after the second dose), TAK-003 demonstrated overall vaccine efficacy
(VE) of 62.0% (95% CI: 56.6% to 66.7%) against virologically-confirmed dengue
(VCD), with 65.0% VE (95% CI: 58.9% to 70.1%) in seropositive individuals and
54.3% VE (95% CI: 41.9% to 64.1%) in seronegative individuals. TAK-003 also
demonstrated 83.6% VE (95% CI: 76.8% to 88.4%) against hospitalized dengue,
with 86.0% VE (95% CI: 78.4% to 91.0%) in seropositive individuals and 77.1% VE
(95% CI: 58.6% to 87.3%) in seronegative individuals. Observations of varied VE
by serotype remained consistent with previously reported results. No evidence
of disease enhancement was observed. TAK-003 was generally well tolerated, and
there were no important safety risks observed. The results reinforce the
potential of TAK-003 to help protect those who are living in or traveling to
dengue-endemic countries.
“Our dengue vaccine candidate continued to provide protection
against dengue throughout three years, and was especially robust in
preventing hospitalization,” said Derek Wallace, VP, Dengue Global Program
Leader at Takeda. "These results reinforce my confidence
that TAK-003 can help address the significant global burden of
dengue.”
As previously reported, the TIDES
trial met its primary endpoint of overall VE against VCD at
12-months follow-up (VE: 80.2%; 95% CI: 73.3% to 85.3%; p<0.001) and
all secondary endpoints for which there were a
sufficient number of dengue cases (measured at 18-months follow-up). The TIDES
trial has been amended to include the evaluation of a booster dose to address
the waning of overall VE observed over time (from 12 through 36 months after
the second dose), largely driven by outpatient dengue. Takeda intends to
publish results of the 36-month exploratory analysis in a peer-reviewed journal
this year.
TIDES safety and efficacy data through 36-months follow-up was included
in regulatory submissions to the European Union and dengue-endemic countries
and will be part of additional filings planned for 2021, including in the
United States. Takeda will seek an indication for TAK-003 for the prevention of
dengue disease in individuals four to 60 years of age, regardless of previous
virus exposure, based on data in both adults and children. There remains a need
for dengue vaccines that can be used in both dengue-naïve and dengue-exposed
adults and children.
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