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

• 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
• 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

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）：建议所有孕妇使用季节性三价流感病毒疫苗（TIV），因为她们认为她们的并发症，住院和流感死亡的高风险很高。怀孕中的疫苗接种还可以为婴儿从0-6个月起提供保护，这是一个未批准疫苗接种的高风险组。但是，几乎没有关于适当的母体抗体反应的预测指标或对新生儿的足够抗体转移的数据。对孕妇TIV后抗体反应的非怀孕成人和动物以及我们自己的初步数据的研究表明，社会心理压力和肥胖是两个关键的危险因素，在这方面值得关注。 研究设计：我们将检查社会心理应激和肥胖对孕妇对TIV的抗体反应的影响，以及2）抗体从母亲到新生儿的转移。这项研究将包括180名妇女（90名肥胖，90个非肥胖），她们将在妊娠第二个三个月（妊娠13-28周）中接种疫苗。孕产妇抗体水平将在疫苗接种之前，疫苗接种后和交付时评估。新生儿抗体水平将在分娩时通过脐带血测量。数据将在三个流感季节中收集。在每个季节，将评估60名女性； 30肥胖和30个非肥胖者，年龄，种族，平等和社会经济地位将相似。每年对A/H1N1，A/H3N2和B菌株的抗炎性抗体滴度将由血凝抑制（HAI）测试确定。 假设1：在孕妇中，压力和肥胖症都可以预测在TIV后一个月实现保护性抗体反应的可能性降低。肥胖症的影响将是高压力的女性中最明显的。假设2：更大的母体压力和肥胖症将预测新生脐带血中保护性抗体水平的可能性降低，这两种危险因素的影响最大。我们将检查四种可能导致新生儿影响的途径：1）母体抗体反应的幅度受损（假设1），2）从疫苗接种后一个月到分娩的孕产妇抗体水平的维持较差，3）较低的母亲孕产妇传播（新生儿血液/母体血液/母体抗体比率）较高（新的孕妇抗体比率），以及4）较高的特先生率。 这项研究检验了创新的假设，即在孕妇孕产妇疫苗接种后，新生儿的孕产妇抗体反应和抗体水平显着损害了孕产妇抗体反应和抗体水平。如果我们的假设得到证实，我们将确定并量化新的风险因素对受到流感并发症，孕妇和婴儿的两个人群的不良免疫保护的影响。现在，对于其他高剂量疫苗或两种剂量时间表，对于其他高风险群体，他们对传统TIV的反应不佳，包括老年人，儿童和移植者。这项研究将确定是否有理由重新评估具有特定危险因素的孕妇的流感疫苗建议。