Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Butantan Foundation | OTHER |
| Coalition for Epidemic Preparedness Innovations | OTHER |
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases: Test-positive for Chikungunya virus |
| ||
| Controls: Test-negative for Chikungunya virus |
|
| 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 linked to this observational study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Study start through study completion, an average of 23 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Study start through study completion, an average of 23 months |
| Measure | Description | Time Frame |
|---|---|---|
| Detection of CHIKV in VLA1553-vaccinated (≥14 days after vaccination) and unvaccinated individuals with CHIKV-like symptoms confirmed by RT-PCR, stratified by sex and age group (≥18 to 59 and ≥ 60 years, depending on the age group approved for the PVS) | Study start through study completion, an average of 23 months | |
| Detection of CHIKV in VLA1553-vaccinated (≥14 days after vaccination) and unvaccinated study individuals with CHIKV-like symptoms confirmed by RT-PCR, stratified by time since vaccination (from 0 to 6 months after Day 15) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Residents of the selected areas, within the age limits approved for the PVS, presenting at the health care facilities during the study period.
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Study start through study completion, an average of 23 months |
| CHIKV hospitalizations (confirmed by RT-PCR) in VLA1553-vaccinated (≥14 days after vaccination) and unvaccinated study individuals; CHIKV deaths (confirmed by RT-PCR) in VLA1553-vaccinated (≥14 days after vaccination) and unvaccinated study individuals | Study start through study completion, an average of 23 months |
| Magnitude and direction of estimated level of bias due to unmeasured pre-vaccination strategy CHIKV infection, and estimated VE corrected for this bias. | Study start through study completion, an average of 23 months |
| 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 |
Not provided
Not provided