A Multicenter Study to Evaluate Safety and Immunogenicity of a Live-attenuated Chikungunya Vaccine in Adolescents

Summary

This was a prospective, randomized, double-blinded, multicenter, pivotal study evaluating the full dose of VLA1553 (1 x10E4 TCID50 per dose) in comparison to a placebo control. The dose of VLA1553 or control was administered as single vaccination on Day 1. Overall, approximately 750 male and female participants aged 12 years to \<18 years were enrolled into the study. After completion of the trial, a Post Trial Access program was performed to offer the VLA1553 vaccine to all placebo recipients.

Timeline

Start

2022-02-14

Primary completion

2023-03-14

Completion

2024-02-16

Publications

• Results Buerger V, Pfeiffer A, Schoengrundner P, Seebacher J, Hochreiter R, Kosulin K, Zoihsl O, Weisova P, Mader R, Loch AP, Morandi E Jr, Nogueira ML, de Brito CAA, Croda J, Teixeira MM, Coelho IC, Gurgel R, da Fonseca AJ, de Lacerda MVG, Moreira ED Jr, Veiga APR, Eder-Lingelbach S, Jaramillo JC. Safety and immunogenicity of a live-attenuated chikungunya virus vaccine in adolescents: final results from a 12-month, double-blind, randomised, placebo-controlled, phase 3 trial in endemic areas of Brazil. Lancet Infect Dis. 2026 Apr;26(4):417-428. doi: 10.1016/S1473-3099(25)00631-0. Epub 2025 Dec 8.
• Buerger V, Hadl S, Schneider M, Schaden M, Hochreiter R, Bitzer A, Kosulin K, Mader R, Zoihsl O, Pfeiffer A, Loch AP, Morandi E Jr, Nogueira ML, de Brito CAA, Croda J, Teixeira MM, Coelho IC, Gurgel R, da Fonseca AJ, de Lacerda MVG, Moreira ED Jr, Veiga APR, Dubischar K, Wressnigg N, Eder-Lingelbach S, Jaramillo JC. Safety and immunogenicity of a live-attenuated chikungunya virus vaccine in endemic areas of Brazil: interim results of a double-blind, randomised, placebo-controlled phase 3 trial in adolescents. Lancet Infect Dis. 2025 Jan;25(1):114-125. doi: 10.1016/S1473-3099(24)00458-4. Epub 2024 Sep 5.

Drugs

Indications