A Test-Negative Case-control Study to Evaluate the Effectiveness of VLA1553 Against Chikungunya Virus Disease During a Pilot Vaccination Strategy in Brazil
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,200
- 试验地点
- 3
- 主要终点
- 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).
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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;
- •Are in an eligible age-group to receive the VLA1553 vaccine;
- •Have been notified in SINAN as a suspected case for CHIK or Dengue surveillance during the study period;
- •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;
- •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.
排除标准
- •Have inconclusive RT-PCR result for CHIKV;
- •Have a detectable vaccine virus identified via sequencing;
- •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;
- •Have the first CHIKV-like symptom onset less than 14 days from date of vaccination.
研究组 & 干预措施
Cases: Test-positive for Chikungunya virus
干预措施: Live-attenuated CHIKV vaccine VLA1553 (Biological)
Controls: Test-negative for Chikungunya virus
干预措施: Live-attenuated CHIKV vaccine VLA1553 (Biological)
结局指标
主要结局
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).
时间窗: Study start through study completion, an average of 23 months
次要结局
- 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)