NK Cell Mediated Influenza Immunity During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- NK cell function
研究概览
简要总结
Pregnant women have increased morbidity and mortality due to infection with influenza. Changes in T cell function have been proposed as possible mechanisms for this finding. We believe that pregnancy induced changes in NK cell phenotype and function also impact influenza immunity. This study will compare the immune response of pregnant women and controls to TIV influenza vaccination as a surrogate for infection. In addition pregnant women with flu like illness will be enrolled to evaluate changes in immune response following influenza infection as compared to vaccination.
详细描述
We will enroll a cohort of 94 healthy pregnant women from the Lucille Packard Children's Hospital Obstetrics Clinic from 2012-2017.
Women will be enrolled during their 2nd and 3rd trimesters, a time of high risk of complications from influenza infection. All subjects will provide blood samples at day 0, then be immunized with TIV as part of their regular medical care, and will return for additional blood samples on approximately days 7 and 28.
In accordance with minimal risk guidelines in pregnant women, a total of 50 cc of blood will be drawn across all three visits (20 cc, 20 cc, and 10 cc respectively).
An additional blood draw of 20 cc will be performed approximately 6 weeks postpartum to coincide with the standard postpartum obstetrical follow up.
This is a purely observational study. There is no treatment or randomization. Influenza vaccination is the standard of care during pregnancy and will not be influenced by our study design. All subjects will receive standard prenatal care, and will have access to maternal fetal medicine experts.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women (18-42 years of age)
- •Pregnant women planning to receive the TIV seasonal influenza vaccine or Pregnant women presenting with influenza like illness
排除标准
- •Oral immunosuppressive agents (inhaled steroids OK)
- •Serious chronic illness including autoimmune disease or chronic viral infections (eg, systemic lupus erythematosis,HIV, hepatitis B or C)
- •Malignancy or blood dyscrasia
- •Type I or II diabetes or morbid obesity (pre-pregnancy BMI>40)(gestational diabetes ok)
- •Presence of fetal cardiac abnormalities
- •Receipt of blood or blood products within the last year
- •Prior receipt of current seasonal influenza vaccine for influenza vaccine arm
- •History of egg allergy for influenza vaccine arm
结局指标
主要结局
NK cell function
时间窗: 2 years
We are assessing the NK cell repertoire and anti-influenza NK cell function
次要结局
未报告次要终点
研究者
Catherine Blish
Assistant Professor
Stanford University