#Safety and immunogenicity of a live-attenuated #chikungunya virus #vaccine in #adolescents: final results from a ... phase 3 trial in endemic areas of #Brazil
Summary Background Chikungunya outbreaks have recurred in Brazil since 2014 . Building on earlier 28-day post-vaccination data , we now report 12-month safety and immunogenicity results of the VLA1553 vaccine in Brazilian adolescents. Methods In this double-blind, randomised, placebo-controlled, phase 3 trial , generally healthy adolescents aged 12–17 years were recruited at ten sites across Brazil. Individuals were excluded for immune-mediated or chronic arthritis or arthralgia, who are are immunologically compromised, or any recent live vaccines. Random allocation via simple block randomisation in a 2:1 ratio was stratified by baseline IgG and IgM serostatus by ELISA to receive a single intramuscular dose of VLA1553 or placebo . Assessed in the per-protocol population 28 days after vaccination, the primary endpoint was the proportion of baseline seronegative participants with chikungunya virus neutralising antibody levels assessed by a serum dilution achieving a 50% plaque redu...