Fig 1.
Design of the phase 3 randomized trial.
Fig 2.
Schematic of the outbreak vector-borne transmission model.
Note that the model is not serotype or serostatus specific. a: infection of humans depending on the number of infected vectors in the area and the neighboring eight areas. a’: same as a, accounting for vaccine efficacy against infection. b and b’: progression from incubation to asymptomatic state depending on vaccination status and efficacy against symptomatic outcome. birth: the number of new noninfected mosquitoes is equal to the number of dead mosquitoes (death Im + death Sm) in order to have a fixed number of vectors per area. c and c’: progression from incubation to symptomatic state depending on vaccination status and efficacy against symptomatic outcome. d, d’, e, and e’: loss of infectiousness of humans depending on vaccination status. E and Ev: exposed humans nonvaccinated and vaccinated. f: vaccination. g: infection of mosquitoes depending on the number of infected humans in the area and their vaccination status. IAs and IAsv: infected asymptomatic humans nonvaccinated and vaccinated. Im: infected mosquitoes. IS and ISv: infected symptomatic humans nonvaccinated and vaccinated. R and Rv: removed (immune or dead after infection) among humans nonvaccinated and vaccinated. S and Sv: susceptible humans nonvaccinated and vaccinated. Sm: susceptible mosquitoes.
Table 1.
Key epidemiological model parameters.
Fig 3.
Cumulative incidence of VCD caused by dengue serotype 2 from first vaccine dose until 4.5 years after the second dose in participants in Sri Lanka by baseline serostatus (safety set).
Table 2.
VE against VCD and hospitalized VCD from first vaccination until the end of part 1 in participants at trial sites in Sri Lanka (safety set).
Fig 4.
Sensitivity analysis of VE and epidemic curves of (A) VCD and (B) hospitalized VCD.
Fig 5.
Tornado plots of the effect of key variables on the cumulative number of (A) VCD cases caused by DENV-2 and (B) hospitalized VCD cases caused by DENV-2.
Extreme low scenario: start vaccination on day 180, 10% coverage, vaccine efficacy 50%, 50% hospitalization, and 25% asymptomatic. Extreme high scenario: start vaccination on day 15, 80% coverage, and vaccine efficacy baseline.