Adult Immunogenicity and Descriptive Safety of TAK-003 Dengue Vaccination: A Systematic Review and Meta-analysis
DOI:
https://doi.org/10.37275/bsm.v10i11.1681Keywords:
Adults, Dengue vaccine, Immunogenicity, Safety, TAK-003Abstract
Background: Adult TAK-003 data differ by formulation, baseline dengue status, coadministration, and outcome definition.
Objective: To synthesize adult immunogenicity and safety of the licensed two-dose final formulation of TAK-003.
Methods: We searched PubMed, Scopus, CENTRAL-derived records, registries, regulatory sources, and citations to the final search update. Screening, extraction, appraisal, and analysis used a reproducible computational workflow without independent duplicate verification. Seropositivity and 270-day serious adverse event (SAE) risk were modeled with binomial-normal logit models; comparative reactogenicity used random-effects risk ratios with modified Hartung-Knapp intervals. Certainty was graded by outcome, and a sensitivity analysis added the single-arm DEN307 cohort.
Results: Of 1,090 records, 606 unique records (553 publications and 53 registry records) were screened; 473 publications were excluded and 80 were retrieved. Five trials supplied quantitative outcomes. Among 620 baseline-seronegative adults, pooled seropositivity about 30 days after dose 2 was 98.7% for DENV-1 (95% CI 95.8–99.6), 99.0% for DENV-2 (97.9–99.6), 96.9% for DENV-3 (95.2–98.0), and 98.4% for DENV-4 (97.0–99.1). With DEN307 added, estimates were 98.8%, 99.2%, 97.1%, and 98.5% (752 participants per serotype). Across four cohorts, 29/1,468 participants had an SAE through day 270 (pooled risk 2.0%, 95% CI 1.4–2.8). Pain and headache estimates, each from two studies, were highly imprecise.
Conclusion: Final-formulation TAK-003 gave high short-term seropositivity in selected adult trial populations. The SAE risk was uncontrolled and does not establish comparative safety. Certainty was low or very low, and inference is limited by study size, surrogate outcomes, and uncontrolled safety data.
Authors
- I Wayan Bagus Abiyoga Suputra1*
- Komang Andjani Putri1
- Cokorda Agung Wahyu Purnamasidhi2
- 1Faculty of Medicine, Universitas Udayana, Denpasar, Indonesia
- 2Department of Internal Medicine, Faculty of Medicine, Universitas Udayana/ Universitas Udayana Hospital, Denpasar, Indonesia
Corresponding author I Wayan Bagus Abiyoga Suputra — i.abiyogas@gmail.com
Article history
- Submitted
- Accepted
- Published
Downloads
Published
Issue
Section
License
Copyright (c) 2026 I Wayan Bagus Abiyoga Suputra, Komang Andjani Putri, Cokorda Agung Wahyu Purnamasidhi
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
Copyright and licensing
Copyright in each article remains with the author(s). Authors grant Bioscientia Medicina: Journal of Biomedicine and Translational Research a non-exclusive right of first publication and the right to identify itself as the original publisher. No exclusive transfer of copyright is required.
All articles are published under the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License (CC BY-NC-SA 4.0): https://creativecommons.org/licenses/by-nc-sa/4.0/. Users may copy, redistribute, remix, transform, and build upon the material for non-commercial purposes, provided appropriate attribution is given, a link to the license is supplied, changes are indicated, and adaptations are distributed under the same license.
The license applies to the article's scholarly content unless a credit line states otherwise. Third-party material may be subject to separate rights. Authors retain patent, trademark, moral, and research-data rights. The copyright year follows the article's publication date.
