Assessment of Chikungunya Virus Seroprevalence Before VLA1553 Vaccination in the Municipalities Selected for Participation in the VLA1553 Pilot Vaccination Strategy in Brazil

NCT ID: NCT07163845

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 4988 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-22
• Study Completion Date: 2026-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Chikungunya Virus Infection

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Live-attenuated CHIKV vaccine VLA1553

Non-interventional study: VLA1553 is used in the pilot vaccination strategy which is carried out after this observational study.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação Butantan

UNKNOWN

Sponsor Role: collaborator

Coalition for Epidemic Preparedness Innovations

OTHER

Sponsor Role: collaborator

Valneva Austria GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

Brazil

Other Identifiers

VLA1553-407

Identifier Type: -

Identifier Source: org_study_id