Three-year Efficacy and Safety of Takeda's Dengue Vaccine Candidate (TAK-003)
Issued Date
2022-07-01
Resource Type
ISSN
10584838
eISSN
15376591
Scopus ID
2-s2.0-85137134527
Pubmed ID
34606595
Journal Title
Clinical Infectious Diseases
Volume
75
Issue
1
Start Page
107
End Page
117
Rights Holder(s)
SCOPUS
Bibliographic Citation
Clinical Infectious Diseases Vol.75 No.1 (2022) , 107-117
Suggested Citation
Rivera L., Biswal S., Sáez-Llorens X., Reynales H., López-Medina E., Borja-Tabora C., Bravo L., Sirivichayakul C., Kosalaraksa P., Vargas L.M., Yu D., Watanaveeradej V., Espinoza F., Dietze R., Fernando L.K., Wickramasinghe P., Moreira E.D., Fernando A.D., Gunasekera D., Luz K., Da Cunha R.V., Rauscher M., Zent O., Liu M., Hoffman E., LeFevre I., Tricou V., Wallace D., Alera M.T., Borkowski A. Three-year Efficacy and Safety of Takeda's Dengue Vaccine Candidate (TAK-003). Clinical Infectious Diseases Vol.75 No.1 (2022) , 107-117. 117. doi:10.1093/cid/ciab864 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/85732
Title
Three-year Efficacy and Safety of Takeda's Dengue Vaccine Candidate (TAK-003)
Author(s)
Rivera L.
Biswal S.
Sáez-Llorens X.
Reynales H.
López-Medina E.
Borja-Tabora C.
Bravo L.
Sirivichayakul C.
Kosalaraksa P.
Vargas L.M.
Yu D.
Watanaveeradej V.
Espinoza F.
Dietze R.
Fernando L.K.
Wickramasinghe P.
Moreira E.D.
Fernando A.D.
Gunasekera D.
Luz K.
Da Cunha R.V.
Rauscher M.
Zent O.
Liu M.
Hoffman E.
LeFevre I.
Tricou V.
Wallace D.
Alera M.T.
Borkowski A.
Biswal S.
Sáez-Llorens X.
Reynales H.
López-Medina E.
Borja-Tabora C.
Bravo L.
Sirivichayakul C.
Kosalaraksa P.
Vargas L.M.
Yu D.
Watanaveeradej V.
Espinoza F.
Dietze R.
Fernando L.K.
Wickramasinghe P.
Moreira E.D.
Fernando A.D.
Gunasekera D.
Luz K.
Da Cunha R.V.
Rauscher M.
Zent O.
Liu M.
Hoffman E.
LeFevre I.
Tricou V.
Wallace D.
Alera M.T.
Borkowski A.
Author's Affiliation
SENACYT - Secretaría Nacional de Ciencia, Tecnología e Innovación
Faculty of Tropical Medicine, Mahidol University
Takeda Pharmaceuticals International AG
De La Salle Medical and Health Sciences Institute
University of the Philippines Manila
Gokila
University of Kelaniya
University of Colombo
Universidad del Valle, Cali
Federal University of Espirito Santo
Faculty of Medicine, Khon Kaen University
Fundacao Oswaldo Cruz
Universidade Federal do Rio Grande do Norte
Universidade Federal de Mato Grosso do Sul
Phramongkutklao College of Medicine
Caimed
National Autonomous University of Nicaragua
University of Sri Jayawardenenpura
Negombo General Hospital
Takeda Vaccines Inc.
Caimed SAS
Philippines-Armed Forces Research Institute of Medical Sciences Virology Research Unit
Hospital Maternidad Nuestra Señora de la Altagracia
Faculty of Tropical Medicine, Mahidol University
Takeda Pharmaceuticals International AG
De La Salle Medical and Health Sciences Institute
University of the Philippines Manila
Gokila
University of Kelaniya
University of Colombo
Universidad del Valle, Cali
Federal University of Espirito Santo
Faculty of Medicine, Khon Kaen University
Fundacao Oswaldo Cruz
Universidade Federal do Rio Grande do Norte
Universidade Federal de Mato Grosso do Sul
Phramongkutklao College of Medicine
Caimed
National Autonomous University of Nicaragua
University of Sri Jayawardenenpura
Negombo General Hospital
Takeda Vaccines Inc.
Caimed SAS
Philippines-Armed Forces Research Institute of Medical Sciences Virology Research Unit
Hospital Maternidad Nuestra Señora de la Altagracia
Other Contributor(s)
Abstract
Background: Takeda's live attenuated tetravalent dengue vaccine candidate (TAK-003) is under evaluation in a long-Term clinical trial across 8 dengue-endemic countries. Previously, we have reported its efficacy and safety in both seronegative and seropositive participants and that its performance varies by serotype, with some decline in efficacy from first to second year postvaccination. This exploratory analysis provides an update with cumulative and third-year data. Methods: Healthy 4-16 year olds (n=20099) were randomized 2:1 to receive TAK-003 or placebo (0, 3 month schedule). The protocol included baseline serostatus testing of all participants and detection of all symptomatic dengue throughout the trial with a serotype specific reverse transcriptase-polymerase chain reaction. Results: Cumulative efficacy after 3 years was 62.0% (95% confidence interval, 56.6-66.7) against virologically confirmed dengue (VCD) and 83.6% (76.8-88.4) against hospitalized VCD. Efficacy was 54.3% (41.9-64.1) against VCD and 77.1% (58.6-87.3) against hospitalized VCD in baseline seronegatives, and 65.0% (58.9-70.1) against VCD and 86.0% (78.4-91.0) against hospitalized VCD in baseline seropositives. Efficacy against VCD during the third year declined to 44.7% (32.5-54.7), whereas efficacy against hospitalized VCD was sustained at 70.8% (49.6-83.0). Rates of serious adverse events were 2.9% in TAK-003 group and 3.5% in placebo group during the ongoing long-Term follow-up (ie, second half of the 3 years following vaccination), but none were related. No important safety risks were identified. Conclusions: TAK-003 was efficacious against symptomatic dengue over 3 years. Efficacy declined over time but remained robust against hospitalized dengue. A booster dose evaluation is planned.