Preterm Immune System Development and Response to Immunization
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 145
- 试验地点
- 7
- 主要终点
- antibody immune response to routine vaccinations in very preterm infants
研究概览
简要总结
In this study the response to vaccination and development of the immune system in very preterm infants upon the current vaccination schedule will be compared to healthy term infants.
详细描述
Preterm infants are at increased risk of developing infections early in life due to a less mature immune system compared to full-term infants. Moreover, protection by the placental transfer of maternal antibodies in general and specifically against vaccine antigens has shown to be significantly lower in very preterm infants (gestational age (GA)< 32 weeks) compared to term infants. In this study we aim to investigate the immune system development of very preterm infants. Adequate immune response to vaccination is considered both clinically important as well as a functional test of the immune system. However, data on the antibody and Ag-specific memory B cell response to vaccination in preterm infants are limited.
Primary objective is to study the antibody immune response to routine vaccinations in very preterm infants (GA<32 weeks). Secondary aim is to study the immune system more extensively using flow cytometry, ELISA and single cell transcriptomics to measure development of Ag-specific memory B cells raised in response to vaccination, and by using proteomics, epigenetics, and microbiome studies.
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
- 1 Day 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Parents/guardians of the infant are not able or willing to provide informed consent
- •Infant with congenital anomaly which are more likely to cause adverse effects after immunization (for example hemodynamically significant congenital heart defect)
- •Infant with a (possible) HIV infection or immunodeficiency
- •Maternal use of immunosuppressive drugs during pregnancy
结局指标
主要结局
antibody immune response to routine vaccinations in very preterm infants
时间窗: 6 months
IgG antibody concentrations against six vaccine antigens in preterm-born infants following primary series of routine vaccinations with Vaxelis in order to assess the proportion of children with IgG concentrations above international-defined thresholds for protection.
次要结局
- IgG antibody concentrations following routine vaccinations with 10-valent pneumococcal conjugate vaccine after primary series and booster vaccination.(6 and 12 months)
- IgG antibody concentrations against pertussis antigens at 2 months of age in preterm-born infants after maternal Tdap vaccination and in infants whose mother did not receive maternal Tdap vaccination.(2 months)
- comparison of response to vaccination between preterm infants and healthy term infants(6 and 12 months)
- IgG antibody concentrations in relation to maternal antibody concentrations against vaccine antigens(birth, 2,6 and 12 months)
- number of antigen-specific memory B cells in cells/microliter following routine vaccinations after primary series and booster vaccination(6 and 12 months)
- IgG antibody concentrations following booster of routine vaccination with Vaxelis(12 months)
- geometrical mean concentrations following primary series and booster of routine vaccination with Vaxelis.(6 and 12 months)
- Comparison of number of antigen-specific memory B cells in cells/microliter with and without preceding maternal Tdap vaccination(6 and 12 months)