| Registry | NCT07163845 |
|---|---|
| Status | Active not recruiting |
| Study type | Observational |
| Enrollment | 5354 (Actual) |
| Sponsor | Valneva Austria GmbH (Industry); collaborators: Butantan Foundation, Coalition for Epidemic Preparedness Innovations |
| Conditions | Chikungunya Virus Infection |
| Interventions | Live-attenuated CHIKV vaccine VLA1553 (Biological) |
| Dates | start 2025-09-22, primary completion 2026-07-31 (estimated), completion 2026-12-31 (estimated), first posted 2025-09-09, last updated 2026-02-11 |
| Locations | 4 sites in Brazil |
Related Papers Related Patents Related Grants Related Experts
All trials for Chikungunya Virus Infection All trials of Live-attenuated CHIKV vaccine VLA1553
This is a cross-sectional serosurvey using household cluster sampling conducted before the VLA1553 pilot vaccination strategy will be implemented in about 10 municipalities in Brazil.
Households will be selected randomly using a multi-stage random sampling at the census tract, street, and household levels, to select study participants. The study aims to prospectively evaluate the association between vaccination uptake and previous CHIKV exposure (pre-existing immunity to CHIKV infection) in the age-group approved per label in Brazil (e.g., adults \[≥18 years of age\] or individuals ≥12 years of age). Seroprevalence among vaccinated and unvaccinated individuals will be used to parameterize a probabilistic bias analysis conducted as part of the VE study. Finally, the study will explore the prevalence of CHIKV exposure in the different study communities before the VLA1553 pilot vaccination strategy in individuals ≥2 years of age.
Sex: All, ages: 2 Years to any, accepts healthy volunteers
Inclusion Criteria: 1. Individuals residing in the selected municipalities of Brazil where the VLA1553 pilot vaccination strategy will be implemented. 2. Individuals ≥2 years of age 3. Individuals who sleep 3 nights a week or more in a household that is selected by cluster sampling. Exclusion Criteria: 1\. Individuals or their legally accepted representatives (LAR) who are not willing or not able to provide informed consent (and assent, as required) according to country-specific procedures.
| Facility | City | Country | Status |
|---|---|---|---|
| Universidade Federal Do Ceará | Fortaleza, Ceará | Brazil | |
| Universidade Federal de Minas Gerais, CT Terapias Avançadas e Inovadoras | Belo Horizonte, Minas Gerais | Brazil | |
| Centro de Pesquisas Clínicas Universidade Federal Sergipe, Hospital e Maternidade São João de Deus | Laranjeiras, Sergipe | Brazil | |
| Fundação Faculdade Regional De Medicina De São José Do Rio Preto | São Pedro, São Paulo | Brazil |