Maternal Stress, Obesity, and Influenza Virus Vaccine Immunogenicity in Pregnancy

妊娠期母亲压力、肥胖和流感病毒疫苗的免疫原性

基本信息

批准号：
8577552
负责人：
Lisa Michelle Christian
金额：
$ 38.39万
依托单位：
OHIO STATE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-08-07 至 2018-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8577552
关键词：
Adult Age Animals Antibodies Antibody Formation Anxiety Attention Centers for Disease Control and Prevention (U.S.)Cessation of life Child Complex Data Distress Dose Elderly Family suidae Foundations Goals Hemagglutination Inhibition Tests Hospitalization Immune Individual Infant Influenza Influenza A Virus, H1N1 Subtype Influenza vaccination Longevity Maintenance Maternal antibody Maternal-Fetal Transmission Measures Meta-Analysis Modeling Mothers Newborn Infant Non obese Obesity Odds Ratio Outcome Pathway interactions Pattern Pregnancy Pregnancy Trimesters Pregnant Women Premature Birth Psychosocial Stress Publishing Race Rattus Recommendation Reporting Research Design Risk Risk Factors Schedule Seasons Severities Socioeconomic Status Stress Testing Time Transplant Recipients Umbilical Cord Blood Vaccinated Vaccination Vaccines Vulnerable Populations Woman anti-influenza clinical practice depressive symptoms disorder prevention flu high risk immunogenicity influenza virus vaccine influenzavirus innovation interest maternal stress mature animal mortality nonhuman primate novel offspring parity prenatal stress public health relevance response vaccin protein

项目摘要

DESCRIPTION (provided by applicant): Seasonal trivalent influenza virus vaccine (TIV) is recommended for all pregnant women because they are considered at high risk for complications, hospitalization, and death from influenza. Vaccination in pregnancy can also provide protection for infants from 0-6 months, a high risk group for whom vaccination is not approved. However, there are virtually no data on predictors of adequate maternal antibody response or sufficient antibody transfer to the newborn. Studies of nonpregnant adults and animals as well as our own preliminary data on antibody responses following TIV in pregnant women demonstrate that psychosocial stress and obesity are two key risk factors that warrant attention in this regard. Study Design: We will examine effects of psychosocial stress and obesity on 1) antibody responses to TIV in pregnant women and 2) antibody transfer from the mother to the newborn. This study will include 180 women (90 obese, 90 non-obese) who will be vaccinated during the 2nd trimester of pregnancy (13-28 weeks gestation). Maternal antibody levels will be assessed prior to vaccination, at one month post-vaccination and at the time of delivery. Newborn antibody levels will be measured via cord blood at the time of delivery. Data will be collected across three influenza seasons. In each season, 60 women will be assessed; 30 obese and 30 non-obese who will be similar in age, race, parity, and socioeconomic status. Anti-influenza antibody titers to A/H1N1, A/H3N2, and B strains in each year will be determined by the hemagglutination inhibition (HAI) test. Hypothesis 1: Among pregnant women, both stress and obesity will predict decreased likelihood of achieving a protective antibody response at one month after TIV. Effects of obesity will be the most pronounced among highly stressed women. Hypothesis 2: Greater maternal stress and obesity will predict decreased likelihood of protective antibody levels in newborn cord blood, with the most robust effects among those with both risk factors. We will examine four pathways which may contribute to effects in newborns: 1) impaired magnitude of maternal antibody response (Hypothesis 1), 2) poorer maintenance of maternal antibody levels from one month post-vaccination to delivery, 3) less efficient maternal-fetal transmission (newborn cord blood/maternal antibody ratio), and 4) higher rates of preterm birth. This study tests the innovative hypotheses that psychosocial stress and obesity substantially impair maternal antibody responses and antibody levels in newborns following maternal influenza vaccination in pregnancy. If our hypotheses are confirmed, we will identify and quantify the impact of novel risk factors for poor immune protection in two populations vulnerable to influenza complications, pregnant women and infants. High dose vaccine or two dose schedules are now available for other high risk groups who show poor responses to traditional TIV including older adults, children, and transplant recipients. This study will determine if it is justified to re-evaluate influenza vaccine recommendations for pregnant women with specific risk factors.

描述（由申请人提供）：建议所有孕妇接种季节性三价流感病毒疫苗（TIV），因为她们被认为是流感并发症、住院和死亡的高风险人群。怀孕期间接种疫苗还可以为 0-6 个月的婴儿提供保护，该婴儿是不批准接种疫苗的高危人群。然而，实际上没有关于足够的母体抗体反应或足够的抗体转移到新生儿的预测因素的数据。对非怀孕成人和动物的研究以及我们自己关于孕妇 TIV 后抗体反应的初步数据表明，心理社会压力和肥胖是这方面值得关注的两个关键风险因素。研究设计：我们将研究心理社会压力和肥胖对 1) 孕妇对 TIV 的抗体反应和 2) 抗体从母亲转移到新生儿的影响。这项研究将包括 180 名女性（90 名肥胖者，90 名非肥胖者），她们将在怀孕第二个月（妊娠 13-28 周）期间接种疫苗。将在疫苗接种前、疫苗接种后一个月和分娩时评估母体抗体水平。新生儿抗体水平将在分娩时通过脐带血进行测量。将收集三个流感季节的数据。每个赛季将评估 60 名女性； 30 名肥胖者和 30 名非肥胖者在年龄、种族、性别和社会经济地位方面相似。通过血凝抑制（HAI）试验测定每年针对甲型H1N1、甲型H3N2、乙型流感病毒的抗体滴度。假设 1：在孕妇中，压力和肥胖都会预测 TIV 后 1 个月实现保护性抗体反应的可能性降低。肥胖对高压力女性的影响最为明显。假设 2：更大的母亲压力和肥胖将预测新生儿脐带血中保护性抗体水平降低的可能性，在同时具有这两种危险因素的人群中影响最为强烈。我们将研究可能对新生儿产生影响的四种途径：1）母体抗体反应程度受损（假设 1），2）从疫苗接种后 1 个月到分娩期间母体抗体水平维持较差，3）母胎效率较低传播（新生儿脐带血/母体抗体比率），4）早产率较高。这项研究测试了创新假设，即心理社会压力和肥胖会严重损害怀孕期间接种流感疫苗后的母体抗体反应和新生儿的抗体水平。如果我们的假设得到证实，我们将确定并量化新的危险因素对易受流感并发症影响的两个人群（孕妇和婴儿）免疫保护不良的影响。高剂量疫苗或两剂疫苗现在可用于对传统 TIV 反应较差的其他高危人群，包括老年人、儿童和移植受者。这项研究将确定重新评估针对具有特定危险因素的孕妇的流感疫苗建议是否合理。