Prospective Surveillance and Case Definition Study of Zika Virus Disease and Infection in Adolescents and Adults in Latin America in Preparation for an Efficacy Trial of a Zika Virus Whole Virion, Purified Inactivated Vaccine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,400
- 试验地点
- 2
- 主要终点
- Number of participants with suspected ZVD and virologically confirmed Zika (VCZ) infection in the cohort
研究概览
简要总结
This prospective, surveillance study will assess the operational Zika virus definition for use in future Zika purified inactivated virus (ZIKV) vaccine efficacy trials in order to identify Zika virus disease (ZVD) cases among the study cohort.
详细描述
This prospective, multicenter, cohort study will conduct active and passive surveillance for ZVD and determine its prevalence and seroconversion incidence in areas of Latin America experiencing Zika epidemic activity. A description of the occurrence of dengue virus and chikungunya virus infections in the cohort may also be provided as differential diagnosis of ZVD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 15 to 40 years on the day of inclusion, currently residing in the site zone, and planning to continue to reside in the site zone for the duration of the study
- •For subjects under the age of majority on the day of inclusion: the assent form has been signed and dated by the subject (if required by local regulations), and the informed consent form has been signed and dated by the parent(s) or legal guardian(s).
- •For subjects at or over the age of majority on the day of inclusion: the informed consent form has been signed and dated.
- •Subject (and parent/guardian if subject is under the age of majority) able to attend all scheduled visits and to comply with all study procedures 4) In good health, based on medical history and physical examination
排除标准
- •Subject is pregnant (as self-reported)
- •Participation in the 4 weeks preceding enrollment, or planned participation during the present study period, in a clinical trial investigating a vaccine, drug, medical device, or a medical procedure
- •Receipt of any dengue or yellow fever vaccine in the 4 weeks preceding the day of enrollment or planned receipt of any dengue or yellow fever vaccine during the study period
- •Receipt of immune globulins, blood or blood-derived products in the past 3 months
- •Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- •History of Zika virus disease, confirmed either clinically, serologically, or virologically
- •Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- •Current alcohol abuse or drug addiction
- •Deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized involuntarily
- •Identified as an investigator or an employee of the investigator or study center, with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the investigator or employee with direct involvement in the proposed study.
结局指标
主要结局
Number of participants with suspected ZVD and virologically confirmed Zika (VCZ) infection in the cohort
时间窗: Day 0 to Day 365
Number of suspected ZVD and VCZ infections
Summary of the signs and symptoms accompanying suspected ZVD and VCZ cases in the study participants
时间窗: Day 0 to Day 365
Occurrence, intensity, and duration of signs and symptoms of ZVD and VCZ cases
次要结局
未报告次要终点