Understanding the Impact of Early-life RSV Infections on Infant Immunity and Long-term Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
研究概览
简要总结
Respiratory Syncytial Virus (RSV) is a main global cause of respiratory illness and death in infants. Previous infant vaccine trials have failed to demonstrate protection. Moreover, RSV infection during early infancy, particularly in infants younger than 4 months of age, is associated with more severe disease, reduced immune protection, and an increased risk of developing childhood asthma. This study aim to investigate the immunological and long-term health effects of a first exposure to RSV early (<4 months) versus late (>6-9 months) in infancy.
详细描述
In British Columbia (Canada), RSV cases rise each year after mid-October, until April, peaking in December. This study compares outcomes between infants born in April to June, who will be naturally exposed to RSV >6-9 months of age versus infants born in September to November, who will be naturally exposed to RSV <4 months of age. Most infants become infected during their first RSV year.
Primary Objectives:
- Compare post-season RSV immune responses between the spring cohort of infants born in April to June versus the fall cohort of infants born in September to November.
- Compare respiratory outcomes at 3 years of age between the spring cohort of infants born in April to June versus the fall cohort of infants born in September to November.
Secondary Objectives:
- Identify immune maturation events linked to stronger post-season RSV antibody responses.
- Determine how the gut and upper airway microbiota co-evolve in infants over the first year of life, and how these dynamics shape RSV risk, and are shaped by host-related, and specifically seasonal factors (i.e. Apr-Jun versus Sept-Nov).
- Compare immune responses during acute RSV infections between the spring cohort of infants born in April to June versus the fall cohort of infants born in September to November.
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
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Birthing parent/child pairs with a delivery date in April, May or June or September, October or November who delivered or are planning to deliver at BC Women's Hospital + Health Centre or a nearby, local hospital.
排除标准
- •Severe pregnancy-related complications or chronic medical conditions in the children making them automatically eligible to receiving RSV immunoprophylaxis in British Columbia (e.g. infants born prematurely < 35 weeks of gestation, or with chronic medical conditions).
研究者
Pascal Lavoie
Professor and Neonatologist
University of British Columbia