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

N/AEnrolling By InvitationNCT07347002

Valneva Austria GmbH1,200 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

1,200

Conditions

Chikungunya Virus Infection

Interventions

Live-attenuated CHIKV vaccine VLA1553BIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 59 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (4)

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

Outcomes

Primary Outcomes

Detection of CHIKV in VLA1553-vaccinated (≥14 days after vaccination) and unvaccinated study individuals with CHIKV-like symptoms confirmed by reverse transcriptase polymerase chain reaction (RT-PCR).

Time frame: Study start through study completion, an average of 23 months

Secondary Outcomes

Detection of CHIKV in VLA1553-vaccinated (≥14 days after vaccination) and unvaccinated study individuals ≥50 years of age with CHIKV-like symptoms confirmed by RT-PCR.

Time frame: Study start through study completion, an average of 23 months

Data from ClinicalTrials.gov

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