Chikungunya Virus Infection
Conditions
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).
Interventions
BIOLOGICALLive-attenuated CHIKV vaccine VLA1553
Non-interventional study: VLA1553 is used in the pilot vaccination strategy which is linked to this observational study.
Sponsors
Valneva Austria GmbH
Butantan Foundation
Coalition for Epidemic Preparedness Innovations
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
1. Have a CHIKV RT-PCR result registered from a municipality where the pilot vaccination strategy is implemented and is in scope of the VLA1553-402 study; 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 a detectable vaccine virus identified via sequencing; 3. For vaccinated and CHIV RT-PCR positive individuals, have no valid sequencing result available for RT-PCR positive samples collected within 30 days post-vaccination; 4. Have the first CHIKV-like symptom onset less than 14 days from date of vaccination.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
Countries
Brazil
Outcome results
None listed