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Vaccine Detail
TAK-003 |
Vaccine Information |
- Vaccine Name: TAK-003
- Target Pathogen: Dengue Virus
- Target Disease: Dengue Fever
- Product Name: DENVax
- Type: Live, attenuated vaccine
- Status: Clinical trial
- Host Species for Licensed Use: None
- Antigen: whole virus (DENV2) and prM/E (serotypes 1 - 4) (Torres-Flores et al., 2022)
- Preparation: (Torres-Flores et al., 2022)Tak-003/DENVax is based on a live-attenuated DENV-2 strain (PDK-53-V) in which the pre-membrane (prM) and envelope (E) genes of YFV have been replaced by the homologous genes from each one of the four DENV serotypes
- Immunization Route: Intramuscular injection (i.m.)
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Host Response |
Human Response
- Vaccination Protocol: Healthy children and adolescents 4 to 16 years of age in regions of Asia and Latin America were randomly assigned in a 2:1 ratio (stratified according to age category and region) to receive two doses of vaccine or placebo 3 months apart. (Biswal et al., 2019)
- Immune Response: Of the 20,071 participants who were given at least one dose of vaccine or placebo (safety population), 19,021 (94.8%) received both injections and were included in the per-protocol analysis. The overall vaccine efficacy in the safety population was 80.9% (95% confidence interval [CI], 75.2 to 85.3; 78 cases per 13,380 [0.5 per 100 person-years] in the vaccine group vs. 199 cases per 6687 [2.5 per 100 person-years] in the placebo group). In the per-protocol analyses, vaccine efficacy was 80.2% (95% CI, 73.3 to 85.3; 61 cases of virologically confirmed dengue in the vaccine group vs. 149 cases in the placebo group), with 95.4% efficacy against dengue leading to hospitalization (95% CI, 88.4 to 98.2; 5 hospitalizations in the vaccine group vs. 53 hospitalizations in the placebo group). Planned exploratory analyses involving the 27.7% of the per-protocol population that was seronegative at baseline showed vaccine efficacy of 74.9% (95% CI, 57.0 to 85.4; 20 cases of virologically confirmed dengue in the vaccine group vs. 39 cases in the placebo group). (Biswal et al., 2019)
- Side Effects: The incidence of serious adverse events was similar in the vaccine group and placebo group (3.1% and 3.8%, respectively) (Biswal et al., 2019)
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References |
Biswal et al., 2019: Biswal S, Reynales H, Saez-Llorens X, Lopez P, Borja-Tabora C, Kosalaraksa P, Sirivichayakul C, Watanaveeradej V, Rivera L, Espinoza F, Fernando L, Dietze R, Luz K, Venâncio da Cunha R, Jimeno J, López-Medina E, Borkowski A, Brose M, Rauscher M, LeFevre I, Bizjajeva S, Bravo L, Wallace D. Efficacy of a Tetravalent Dengue Vaccine in Healthy Children and Adolescents. The New England journal of medicine. 2019; 381(21); 2009-2019. [PubMed: 31693803].
Torres-Flores et al., 2022: Torres-Flores JM, Reyes-Sandoval A, Salazar MI. Dengue Vaccines: An Update. BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy. 2022; 36(3); 325-336. [PubMed: 35608749].
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