Immunogenicity, Safety, and Efficacy of a Tetravalent Dengue Vaccine in Children and Adolescents: An Analysis by Age Group
1
Issued Date
2025-01-15
Resource Type
ISSN
10584838
eISSN
15376591
Scopus ID
2-s2.0-85217853216
Pubmed ID
38995684
Journal Title
Clinical Infectious Diseases
Volume
80
Issue
1
Start Page
199
End Page
206
Rights Holder(s)
SCOPUS
Bibliographic Citation
Clinical Infectious Diseases Vol.80 No.1 (2025) , 199-206
Suggested Citation
Borja-Tabora C., Fernando L.K., Lopez Medina E., Reynales H., Rivera L., Saez-Llorens X., Sirivichayakul C., Yu D., Folschweiller N., Moss K.J., Rauscher M., Tricou V., Zhao Y., Biswal S. Immunogenicity, Safety, and Efficacy of a Tetravalent Dengue Vaccine in Children and Adolescents: An Analysis by Age Group. Clinical Infectious Diseases Vol.80 No.1 (2025) , 199-206. 206. doi:10.1093/cid/ciae369 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/105389
Title
Immunogenicity, Safety, and Efficacy of a Tetravalent Dengue Vaccine in Children and Adolescents: An Analysis by Age Group
Author's Affiliation
Faculty of Tropical Medicine, Mahidol University
Takeda Pharma AG
De La Salle Medical and Health Sciences Institute
Universidad del Valle, Cali
Research Institute for Tropical Medicine
Negombo General Hospital
Hospital del Niño Dr. José Renán Esquivel
CAIMED
Hospital Maternidad Nuestra Senora de Altagracia
Takeda Pharma AG
De La Salle Medical and Health Sciences Institute
Universidad del Valle, Cali
Research Institute for Tropical Medicine
Negombo General Hospital
Hospital del Niño Dr. José Renán Esquivel
CAIMED
Hospital Maternidad Nuestra Senora de Altagracia
Corresponding Author(s)
Other Contributor(s)
Abstract
Background. Dengue is an increasing threat to global health. This exploratory analysis evaluated the immunogenicity, safety, and vaccine efficacy (VE) of a live-attenuated tetravalent dengue vaccine (TAK-003) in participants enrolled in the phase 3 DEN-301 trial (NCT02747927), stratified by baseline age (4–5 years, 6–11 years, or 12–16 years). Methods. Participants were randomized 2:1 to receive 2 doses of TAK-003, administered 3 months apart, or placebo. Dengue serostatus was evaluated at enrolment. VE against virologically confirmed dengue (VCD) and hospitalized VCD; immunogenicity (geometric mean titers [GMTs]); and safety were evaluated per age group through ∼4 years postvaccination. Results. VE against VCD across serotypes was 43.5% (95% confidence interval [CI]: 25.3%, 57.3%) for 4–5 year-olds; 63.5% (95% CI: 56.9%, 69.1%) for 6–11 year-olds, and 67.7% (95% CI: 57.8%, 75.2%) for 12–16 year-olds. VE against hospitalized VCD was 63.8% (95% CI: 21.1%, 83.4%), 85.1% (95% CI: 77.1%, 90.3%), and 89.7% (95% CI: 77.9%, 95.2%), for the 3 age groups, respectively. GMTs remained elevated against all 4 serotypes for ∼4 years postvaccination, with no evident differences across age groups. No clear differences in safety by age were identified. Conclusions. This exploratory analysis shows TAK-003 was efficacious in dengue prevention across age groups in children and adolescents 4–16 years of age living in dengue endemic areas. Relatively lower VE in 4–5 year-olds was potentially confounded by causative serotype distribution, small sample size, and VE by serotype, and should be considered in benefit-risk evaluations in this age group.