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

NCT07163845 | Active Not Recruiting DMC

• 1 other identifier: VLA1553-407
• Study Type: observational
• Target: 5,354
• Locations: 1 country
• Sites: 4

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.

Conditions

Chikungunya Virus Infection

Outcome Measures

Primary Outcomes (1)

• To prospectively evaluate the association between vaccination uptake and previous CHIKV exposure (pre-existing immunity to CHIKV infection) after implementing a pilot vaccination in the age-group approved per label.

  on Day 1

Other Outcomes (5)

• To evaluate CHIKV seroprevalence in the selected municipalities before the implementation of a pilot vaccination in the population ≥2 years of age

  on Day 1

• The association, measured as an odds ratio, between vaccination uptake and prevaccination strategy CHIKV seropositivity (IgG)

  on Day 1

• Pre-vaccination strategy CHIKV seropositivity (IgG) stratified by vaccination status with VLA1553 vaccine, among the population approved per label

  on Day 1

Interventions

Live-attenuated CHIKV vaccine VLA1553 BIOLOGICAL

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

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population will consist of individuals ≥2 years of age residing in the municipalities where the pilot VLA1553 vaccination strategy will take place and who meet the eligibility criteria

You may qualify if:

• Individuals residing in the selected municipalities of Brazil where the VLA1553 pilot vaccination strategy will be implemented.
• Individuals ≥2 years of age
• Individuals who sleep 3 nights a week or more in a household that is selected by cluster sampling.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Valneva Austria GmbH: lead
• Coalition for Epidemic Preparedness Innovations: collaborator
• Butantan Foundation: collaborator

Study Sites (4)

Universidade Federal Do Ceará

Fortaleza, Ceará, 60430-160, Brazil

Location

Universidade Federal de Minas Gerais, CT Terapias Avançadas e Inovadoras

Belo Horizonte, Minas Gerais, 31270-901, Brazil

Location

Centro de Pesquisas Clínicas Universidade Federal Sergipe, Hospital e Maternidade São João de Deus

Laranjeiras, Sergipe, 49060-025, Brazil

Location

Fundação Faculdade Regional De Medicina De São José Do Rio Preto

São Pedro, São Paulo, 15090-000, Brazil

Location

MeSH Terms

Conditions

Chikungunya Fever

Condition Hierarchy (Ancestors)

Alphavirus Infections; Arbovirus Infections; Vector Borne Diseases; Infections; Mosquito-Borne Diseases; Virus Diseases; Togaviridae Infections; RNA Virus Infections

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 9, 2025
• Study Start: September 22, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

BR (4)