• Manufacturer: Laboratory of Infectious Diseases (LID) of the National Institute of Allergy and Infectious Diseases (NIAID)
• Type: Live, attenuated vaccine
• Status: Clinical trial
• Host Species for Licensed Use: None
• Preparation: (Torres-Flores et al., 2022)TV003/TV005 was constructed by a deletion of 30 nucleotides (172–143) in the TL2 stem-loop of the 3′-UTR of DENV-4 and DENV-1 (rDEN4∆30 and rDEN1∆30), DENV-2 and DENV-3 components were constructed from the rDEN4∆30 backbone
• Immunization Route: Intramuscular injection (i.m.)

Human Response

• Vaccination Protocol: The lyophilized vaccine formulation was reconstituted before administration. One 0.5-ml dose of TAK-003 contained approximately 3.6, 4.0, 4.6, and 5.1 log10 plaque-forming units of TDV-1, TDV-2, TDV-3, and TDV-4, respectively. The placebo was a 0.5-ml injection of saline. Vaccine and placebo were administered subcutaneously into the upper arm (Biswal et al., 2019).
• Immune Response: Against any serotype, efficacy was 80.2% in the per-protocol population (95% confidence interval [CI], 73.3 to 85.3; P<0.001; 61 cases of virologically confirmed dengue in the vaccine group and 149 in the placebo group).
  For specific serotypes; efficacious for DENV-2,3, and 1. 97.7% efficacy against DENV-2, 73.7% efficacy against DENV-1, and 62.6% efficacy against DENV-3; Inconclusive against DENV-4.
  
  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) (Biswal et al., 2019).