Observational Study to Assess the Effectiveness of VLA1553 Vaccine in Preventing Chikungunya During a Pilot Vaccination Strategy in Brazil

NCT ID: NCT07347002

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-02-02
• Study Completion Date: 2027-12-31

Brief Summary

This is an observational, non-interventional, test-negative case-control (TNCC) study to estimate the vaccine effectiveness of VLA1553 against Chikungunya virus in a real-world setting.

Detailed Description

The objective of this study is to evaluate the effectiveness of vaccination with VLA1553 in the prevention of laboratory-confirmed symptomatic cases of CHIK after a single dose of VLA1553 administered as part of a pilot vaccination strategy following licensure in Brazil.

The study will commence following the implementation of the pilot vaccination strategy in selected municipalities. Data for the analyses will be obtained from official Brazilian Ministry of Health surveillance systems, specifically the GAL (Laboratory Environment Management System), SINAN (Notifiable Diseases Information System), and Si-PNI (National Immunization Program Information System).

Conditions

Chikungunya Virus Infection

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Cases: Test-positive for Chikungunya virus

Live-attenuated CHIKV vaccine VLA1553

Intervention Type: BIOLOGICAL

Non-interventional study: VLA1553 is used in the pilot vaccination strategy which is linked to this observational study.

Controls: Test-negative for Chikungunya virus

Live-attenuated CHIKV vaccine VLA1553

Intervention Type: BIOLOGICAL

Non-interventional study: VLA1553 is used in the pilot vaccination strategy which is linked to this observational study.

Interventions

Live-attenuated CHIKV vaccine VLA1553

Non-interventional study: VLA1553 is used in the pilot vaccination strategy which is linked to this observational study.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Have place of residence in a municipality where the pilot vaccination strategy is implemented;

2. Are in an eligible age-group to receive the VLA1553 vaccine;

3. Have been notified in SINAN as a suspected case for CHIK or Dengue surveillance during the study period;

4. Have a sample registered in GAL that is collected within 0-5 days following the onset of CHIKV-like symptoms and is tested for CHIKV using RT-PCR;

5. Have complete data in the Brazilian MoH databases (SINAN and GAL) on age, sex, municipality of residence, sample collection date, and date of symptom onset and the healthcare facilities where the suspected case was reported.

Exclusion Criteria

1. Have inconclusive RT-PCR result for CHIKV;

2. Have the first CHIKV-like symptom onset less than 14 days from date of vaccination.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 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

Central Contacts

Valneva Late-Stage Clinical Development

Role: CONTACT

office@valneva.com

+43 1 206 20 0

Other Identifiers

VLA1553-402

Identifier Type: -

Identifier Source: org_study_id