Impact of Helminth Infections During Pregnancy on Humoral Vaccine Immunogenicity in Infants
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 323
- 主要终点
- Difference in Immunoglobulin G (IgG) concentration against EPI vaccine Ags of infants born to helminth infected mothers and non infected mothers at the age of nine months and 12 months
研究概览
简要总结
Helminth infection is associated with low vaccine immunogenicity. Pregnant women are particularly sensitive to helminth infection.
Since most vaccines are given shortly after birth, an effect of parasites on infant immunogenicity is of particular concern. Therefore, within this study the investigators aim to investigate if maternal infection influences vaccine immunogenicity in the newborn.
详细描述
There is evidence that helminth infections during pregnancy affect the immune system of the mother and the unborn child. As a consequence, the antimicrobial- immune and vaccine- response of the infant may be deficient. The aim of the present study is to measure the influence of maternal helminth infection (schistosomal, filarial and intestinal helminth infection) on vaccine immunogenicity of their infants. The main focus is on immune responses of infants to vaccine antigens given as part of the expanded program on immunization (EPI) in Gabon at an age when infants are unlikely to be infected with helminths and are immunologically primed by their intrauterine life. The objective is to investigate if and which species of helminths during pregnancy have an effect on any of the EPI vaccine-induced immune responses.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent form (ICF) by the participant aged 18 years or older or by a legal major representative and the participant
- •Willingness to deliver in one of the two maternities in the study area
- •Willingness and ability to comply with study protocol for the duration of the trial
- •Willingness to give blood for the examinations and to provide samples for helminth assessment (stool, urine, blood)
排除标准
- •Known chronic diseases (diabetes, TB, HIV, HCV or HBV infection); these will be assessed on a regular basis at given examinations during pregnancy
- •Withdrawal of consent
- •Poor general health (including a hemoglobin level out of local reference range)
- •Signs of symptoms of helminth infection which needs immediate treatment of the mother
- •Planned migration from the area
结局指标
主要结局
Difference in Immunoglobulin G (IgG) concentration against EPI vaccine Ags of infants born to helminth infected mothers and non infected mothers at the age of nine months and 12 months
时间窗: 12 months of observation
次要结局
未报告次要终点
研究者
Meral Esen
Groupleader immunology and clinical trials
Centre de Recherche Médicale de Lambaréné