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Peer-reviewedCC BYVaccines

Efficacy, Immunogenicity, Safety, and Evidence Independence of CYD-TDV and TAK-003 Dengue Vaccines in Children and Adolescents: A Systematic Review and Meta-Analysis.

  1. 1Programa de Estudio de Medicina Humana, Facultad de Medicina Humana, Universidad Privada Antenor Orrego, Trujillo 13008, Peru.
  2. 2Programa Academico de Medicina Humana, Facultad de Ciencias de la Salud, Universidad Privada Norbert Wiener, Lima 15072, Peru.

Abstract

Background/Objectives: The efficacy and safety profiles of CYD-TDV and TAK-003 are established, but multiple publications may derive from the same randomized trial population and therefore not represent independent evidence. We evaluated efficacy, immunogenicity, and safety while distinguishing independent trials from overlapping follow-up reports and interpreting absolute effects within each programme. Methods: We conducted a PRISMA 2020 systematic review and meta-analysis of randomized trials and follow-up reports from five databases. Outcomes included virologically confirmed dengue, hospitalization, severe dengue, serotype-specific efficacy, immunogenicity, and safety. Risk ratios (RRs) with 95% confidence intervals (CIs) were calculated; immunogenicity and safety were synthesized narratively. RoB 2 and GRADE were applied. Results: Nine reports were included. CYD-TDV reduced virologically confirmed dengue (RR = 0.41; 95% CI: 0.35-0.48) and hospitalization (RR = 0.41; 95% CI: 0.25-0.67). Across two independent CYD-TDV trials, absolute reductions were 23.2 virologically confirmed dengue cases per 1000 participants (NNV = 44) and 12.0-50.0 hospitalizations per 1000 (NNVs = 84-20). In the primary TIDES report, TAK-003 reduced virologically confirmed dengue (RR = 0.28; 95% CI: 0.22-0.35) and hospitalization (RR = 0.10; 95% CI: 0.05-0.18), with absolute reductions of 23.6 and 12.9 per 1000 (NNVs = 43 and 78). Later TIDES reports extended follow-up of the same population. Conclusions: Both vaccines reduced dengue outcomes within their respective trial programmes. Absolute effects should be interpreted according to baseline risk and trial context, not as direct between-vaccine comparisons. The synthesis distinguishes extended follow-up from independent replication.

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BibTeX
@article{sanchezguanilo2026efficacy,
  title = {{Efficacy, Immunogenicity, Safety, and Evidence Independence of CYD-TDV and TAK-003 Dengue Vaccines in Children and Adolescents: A Systematic Review and Meta-Analysis.}},
  author = {Jessica P Sanchez-Guanilo and Carmen A Contreras and Miguel A Arce-Huamani},
  journal = {Vaccines},
  year = {2026},
  month = sep,
  doi = {10.3390/vaccines14100836},
  url = {https://europepmc.org/article/MED/42931365},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - Efficacy, Immunogenicity, Safety, and Evidence Independence of CYD-TDV and TAK-003 Dengue Vaccines in Children and Adolescents: A Systematic Review and Meta-Analysis.
AU  - Jessica P Sanchez-Guanilo
AU  - Carmen A Contreras
AU  - Miguel A Arce-Huamani
PY  - 2026
DA  - 2026/09/22
JO  - Vaccines
DO  - 10.3390/vaccines14100836
UR  - https://europepmc.org/article/MED/42931365
AB  - Background/Objectives: The efficacy and safety profiles of CYD-TDV and TAK-003 are established, but multiple publications may derive from the same randomized trial population and therefore not represent independent evidence. We evaluated efficacy, immunogenicity, and safety while distinguishing independent trials from overlapping follow-up reports and interpreting absolute effects within each programme. Methods: We conducted a PRISMA 2020 systematic review and meta-analysis of randomized trials and follow-up reports from five databases. Outcomes included virologically confirmed dengue, hospitalization, severe dengue, serotype-specific efficacy, immunogenicity, and safety. Risk ratios (RRs) with 95% confidence intervals (CIs) were calculated; immunogenicity and safety were synthesized narratively. RoB 2 and GRADE were applied. Results: Nine reports were included. CYD-TDV reduced virologically confirmed dengue (RR = 0.41; 95% CI: 0.35-0.48) and hospitalization (RR = 0.41; 95% CI: 0.25-0.67). Across two independent CYD-TDV trials, absolute reductions were 23.2 virologically confirmed dengue cases per 1000 participants (NNV = 44) and 12.0-50.0 hospitalizations per 1000 (NNVs = 84-20). In the primary TIDES report, TAK-003 reduced virologically confirmed dengue (RR = 0.28; 95% CI: 0.22-0.35) and hospitalization (RR = 0.10; 95% CI: 0.05-0.18), with absolute reductions of 23.6 and 12.9 per 1000 (NNVs = 43 and 78). Later TIDES reports extended follow-up of the same population. Conclusions: Both vaccines reduced dengue outcomes within their respective trial programmes. Absolute effects should be interpreted according to baseline risk and trial context, not as direct between-vaccine comparisons. The synthesis distinguishes extended follow-up from independent replication.
SN  - 2076-393X
ER  -