• 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based on a live-attenuated DENV-2 strain (PDK-53-V) in which the pre-membrane (prM) and envelope (E) genes of YFV have been replaced by the homologous genes from each one of the four DENV serotypes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.)

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)