Dados do Trabalho

Título

VLA1553-321 Study: Evaluating Safety and Immunogenicity of Single Dose Chikungunya Vaccine in Adolescents – Rationale and Design for Endemic Setting

Introdução

VLA1553, a live-attenuated Chikungunya virus (CHIKV) vaccine candidate, is designed for prevention of CHIKV. In a pivotal study conducted in a non-endemic setting, the vaccine induced seroresponse rate in 98.9% of participants at Day 29 and was well tolerated.
Here, we aim to evaluate the immunogenicity and safety of VLA1553 in a CHIKV endemic setting (i.e., Brazil), 28-days following vaccination in adolescents 12-18 years, after a intramuscular, single-shot immunization.

Objetivo (s)

The aim of this abstract is to provide the rational and the study design of the study in adolscents for VLA 1553-321 that was running in Brazil and the recruitment phase was stopped on February 13rd 2023

Material e Métodos

This is a multicenter, randomized, double-blinded, trial evaluating administration of VLA1553 on Day 1 compared to placebo. Subjects were randomized in a 2:1 ratio to VLA1553 (n= 500) or placebo (n= 250). 750 male and female subjects aged 12-18 years were enrolled in the study, stratified by Enzyme Linked Immunosorbent Assay (ELISA) baseline serostatus: 20% seropositive and 80% seronegative for CHIKV. Age de-escalation of sentinel cohorts were initiated. Enrollment began with 30 sentinel subjects from Cohort I (15 to <18 years) and then progressed to Cohort II (12 to <15 years). The primary efficacy endpoint is a surrogate endpoint defined as μPRNT50 ≥ 150 for μPRNT baseline negative subjects 28-days post-vaccination. Safety will be evaluated by the frequency and severity of solicted and unsolicited adverse events until 28-days and 6-months post-vaccination. Subjects will return at Day 8, Day 29, Month 3, Month 6, and Month 12 for safety and immunogenecity evaluations (Figure 1).
The VLA1553-321 study will determine the immunogenicity and safety of V1553 for the prevention of CHIKV in an endemic setting.

Resultados e Conclusão

The results are still not available and should
Data base lock was on May 2023 and the report of the primary endpoint should be available on November 2023
As mentioned above the aim was to share the rationale and the study design of the study which recrutiment was stopped on Ferbuary 2023

Palavras-chave

*Chikungunya; Vaccine; Adolescents; Brazil; Endemic; Immunogenicity; Safety: Rationale; Design

Agradecimentos

Instituto Butantan SP e equipe de Ensaios Clínicos