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| Name | Class |
|---|---|
| Butantan Foundation | OTHER |
| Coalition for Epidemic Preparedness Innovations | OTHER |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Inclusion Criteria:
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.
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal Do Ceará | Fortaleza | Ceará | 60430-160 | Brazil | ||
| Universidade Federal de Minas Gerais, CT Terapias Avançadas e Inovadoras |
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| 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 |
| Vaccination uptake, measured as cumulative incidence, according to prevaccination strategy CHIKV seropositivity (IgG) | on Day 1 |
| CHIKV seropositivity (IgG) among the study participants ≥2 years of age assessed by rapid diagnostic test (RDT) or Enzyme-Linked Immunosorbent Assay (ELISA) tested on a dried blood spot (DBS) sample before the implementation of the VLA1553 PVS | on Day 1 |
| Belo Horizonte |
| Minas Gerais |
| 31270-901 |
| Brazil |
| Centro de Pesquisas Clínicas Universidade Federal Sergipe, Hospital e Maternidade São João de Deus | Laranjeiras | Sergipe | 49060-025 | Brazil |
| Fundação Faculdade Regional De Medicina De São José Do Rio Preto | São Pedro | São Paulo | 15090-000 | Brazil |
| ID | Term |
|---|---|
| D065632 | Chikungunya Fever |
| ID | Term |
|---|---|
| D018354 | Alphavirus Infections |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D014777 | Virus Diseases |
| D014036 | Togaviridae Infections |
| D012327 | RNA Virus Infections |
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