Maternal Determinants of Immunity to Influenza (MADI-01)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Haemagglutination Inhibition Assay titre
研究概览
简要总结
The overall objective of the project is to determine the impact of pregnancy on the response to influenza immunization.
详细描述
The study compares immune responses to influenza vaccination between a group of pregnant women and a group of non-pregnant controls women. Specifically, the study has three aims:
- To compare the quality of antibodies induced by influenza immunization in pregnant and non-pregnant women;
- To identify immune predictors of vaccine responses in pregnant women and compare them to the determinants of vaccine responses in non-pregnant women;
- To identify immune predictors of the transfer of maternal antibodies to the newborn following influenza immunization during pregnancy;
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
Researchers analyzing the immunological outcomes are blinded to the groups of the subjects (pregnant vs non-pregnant).
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age over 18 and under 40 years.
排除标准
- •Grade III/IV anemia
- •Human Immunodeficiency Virus (HIV) infection
- •Active bacterial infection
- •Opportunistic infection (Tuberculosis, cytomegalovirus (CMV), toxoplasmosis, etc)
- •Inability to understand the nature and extent of the study and the procedures required
- •Current or recent use of immunosuppressive drugs (corticosteroids, anti-tumor necrosis factors (anti-TNF), methotrexate, etc)
- •Active neoplasia
研究组 & 干预措施
Pregnant women
Pregnant women receive one dose of influenza-containing vaccine during pregnancy.
干预措施: Influenza vaccine (Biological)
Non-pregnant women
Non-pregnant women receive one dose of influenza-containing vaccine.
干预措施: Influenza vaccine (Biological)
结局指标
主要结局
Haemagglutination Inhibition Assay titre
时间窗: At delivery
Haemagglutination Inhibition Assay (HAI) titres are used to measure responses to relevant influenza strains. The HAI method exploits the property of the influenza virus to haemagglutinate red blood cells. HAI titres are determined as the highest serum dilution inhibiting haemagglutination. An HAI titre of \>=40 is considered protective in adults. HAI titres will be measured in : * Pregnant women * In umbilical cord blood
次要结局
- Haemagglutination inhibition assay titre(up to 11 months after vaccination)
- Micro neutralization assay titre(up to 11 months after vaccination)
- Influenza virus specific IgG titre(up to 11 month after vaccination)
- Influenza virus specific IgG antibody avidity(up to 11 months after vaccination)
研究者
Nicolas Dauby
Clinical Professor, Infectious Disease Department
Centre Hospitalier Universitaire Saint Pierre