Live-attenuated CHIKV vaccine VLA1553: Non-interventional study: VLA1553 is used in the pilot vaccination strategy which is linked to this observational study.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
59 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
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
Trial sites (3)
Facility
City
Region
Status
Universidade Federal de Minas Gerais, CT Terapias Avançadas e Inovadoras
Belo Horizonte
Minas Gerais
Centro de Pesquisas Clínicas Universidade Federal Sergipe, Hospital e Maternidade São João de Deus
Laranjeiras
Sergipe
Fundação Faculdade Regional De Medicina De São José Do Rio Preto
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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