Safety and Immunogenicity of the Live-Attenuated Quadrivalent Dengue Vaccine V181 Compared With Butantan-DV Among Healthy Adults in Brazil: A Randomized, Double-Blind, Phase 2 Trial

Dengue is caused by infection with 1 of 4 dengue virus (DENV) serotypes (DENV-1 to DENV-4). V181 and Butantan-Dengue Vaccine (Butantan-DV) are independently developed, single-dose, quadrivalent dengue vaccines based on the same attenuated parental strains.

In this randomized, double-blind, active comparator-controlled, multisite, phase 2 trial, we compared the safety and immunogenicity of V181 and Butantan-DV in healthy adults in Brazil. The primary immunogenicity objectives were to compare vaccine-induced neutralizing antibody geometric mean titers (GMTs) and seroconversion rates for DENV-1 to DENV-4 at day 28 postvaccination. The primary and secondary safety objectives, respectively, were to assess vaccine-related serious adverse events and the proportion of participants experiencing solicited adverse events through day 28 postvaccination.