Maternal Determinants of Infant Immunity to Pertussis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- IgG titers specific to Bordetella Pertussis Antigens by Enzyme-linked immunosorbent assay (ELISA)
研究概览
简要总结
The overall objective of the project is to identify the determinants of antibody-mediated immunity in infants born to mothers immunized during pregnancy. Using maternal pertussis immunization as a model, the project will identify key predictors and potential determinants of vaccine responses in pregnant women, of the transfer of maternal antibodies to the newborn and of vaccine responses in infants. A systems biology approach will be used to delineate pre-vaccination and post-vaccination cellular and molecular correlates of the immune response to pertussis immunization in peripheral blood and in breastmilk.
详细描述
The overall objective of the project is to identify the determinants of antibody-mediated immunity to pertussis in infants born to mothers immunized during pregnancy. Three specific objectives will be targeted:
- Determine the impact of pregnancy on the quality of antibody response to pertussis immunization and identify immune predictors of vaccine responses in pregnant and non-pregnant women.
- Identify immune predictors of the transfer of maternal antibodies to the newborn and the presence of antibody in breastmilk following pertussis immunization during pregnancy.
- Determine the impact of maternal antibodies on the quality of antibody response to pertussis immunization in infants born to mothers immunized or not immunized during pregnancy and identify immune predictors of vaccine responses in the first months of life.
To reach these objectives, 40 non-pregnant and 80 pregnant women will be recruited into the study and vaccinated with a single dose of a pertussis containing vaccine (Triaxis). Blood samples will be collected from:
- non-pregnant women: before vaccination, and day 1/7/28 and month 5 post-vaccination.
- pregnant women: before vaccination, day 1/7/28 post-vaccination, at delivery, and week 6/12 post-delivery. At week 6/12 post-delivery, breast milk samples will be collected as well.
At delivery, a placenta fragment will be collected.
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 will be blinded to the groups of the subjects (pregnant vs non pregnant ; infants)
入排标准
- 年龄范围
- 2 Months 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For non-pregnant & pregnant women Age between 18 and 45 years Eligible for Tdap vaccination
- •For infants Born to mothers vaccinated or not with Tdap Vaccinated with hexavalent vaccine Age between 2 and 3 months
排除标准
- •For pregnant and non-pregnant women
- •Inability to understand the nature and extent of the study and the procedures required
- •Grade III/IV anemia,
- •Acute infection at the time of immunization
- •Chronic infections such as Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) infection, acute toxoplasmosis
- •Current or recent use of immunosuppressive drugs
- •Active neoplasia
- •Other vaccine(s) administered at the same time as Tdap vaccination (wash out of 4 weeks after others vaccinations and 28 days after Tdap vaccination )
- •For pregnant women
- •Risk of premature delivery or intrauterine growth retardation
- •Twin or triplet pregnancies
- •For non-pregnant women Last Tdap vaccination < 12 months before
- •For infants:
- •Infants born before 35 weeks of gestation
- •Birthweight below 2.5 kg,
- •Severe neonatal distress
- •Serious congenital abnormalities or congenital infection.
研究组 & 干预措施
Pregnant women
Pregnant women will receive one dose of Pertussis-containing vaccine during pregnancy.
干预措施: Triaxis® (Pertussis-containing vaccine) (Biological)
Non pregnant women
Non-Pregnant women will receive one dose of Pertussis-containing vaccine.
干预措施: Triaxis® (Pertussis-containing vaccine) (Biological)
Infants born to Tdap-vaccinated mothers
Infants whose mothers have been immunized during pregnancy with Tdap vaccine. Infants will receive three doses of Pertussis-containing vaccine (with 28 days interval starting at two months of age).
干预措施: Vaxelis® (Pertussis-containing vaccine) (Biological)
Infants born to non Tdap-vaccinated mothers
Infants whose mothers have not been immunized during pregnancy with Tdap vaccine.
Infants will receive three doses of Pertussis-containing vaccine (with 28 days interval starting at two months of age).
干预措施: Vaxelis® (Pertussis-containing vaccine) (Biological)
结局指标
主要结局
IgG titers specific to Bordetella Pertussis Antigens by Enzyme-linked immunosorbent assay (ELISA)
时间窗: At delivery
IgG titers specific to Bordetella Pertussis Antigens will be assessed by ELISA: * in women vaccinated during pregnancy, at delivery * in umbilical cord blood of infants born to mothers vaccinated during pregnancy
IgG titers specific to Bordetella Pertussis Antigens by Enzyme-linked immunosorbent assay (ELISA)
时间窗: Day 28 post-vaccination
IgG titers specific to Bordetella Pertussis Antigens will be assessed by ELISA: * in women (pregnant and non-pregnant) at 28 days post vaccination * in infants (from unvaccinated mothers and mothers vaccinated during pregnancy) at 28 days post third vaccine dose
次要结局
- IgG titers specific to Bordetella Pertussis Antigens by Enzyme-linked immunosorbent assay (ELISA)(up to 9 month after vaccination)
- CD4+ T cell frequencies specific to Bordetella Pertussis Antigens by flow cytometry(up to 9 month after vaccination)
研究者
Tessa Goetghebuer
Head of Clinic
Centre Hospitalier Universitaire Saint Pierre