Effects of Maternal Influenza Immunization: A Field Trial in Guatemala'

孕产妇流感免疫的影响：危地马拉的现场试验

• 批准号: 8012555
• 负责人: Saad B. Omer
• 金额: $ 23.03万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-23 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8012555
• 关键词: Acute; Antibodies; Bacteria; Bangladesh; Biological Assay; Birth Weight; Budgets; Case Report Form; Childhood; Classification; Clinical; Clinical Trials Data Monitoring Committees; Communities; Complication; Consent; Country; Developing Countries; Double-Blind Method; Enrollment; Fetal Growth; Fetus; Grant; Growth and Development function; Guatemala; Half-Life; Hemagglutination; Hospitalization; Immunization; Incidence; Income; Infant; Infection; Influenza; Influenza vaccination; Informed Consent; Laboratories; Lung diseases; Manuals; Morbidity - disease rate; Mothers; Otitis Media; Outcome; Phase; Pneumonia; Population; Postpartum Women; Pregnancy; Pregnant Women; Procedures; Protocols documentation; Public Health; Randomized; Randomized Controlled Trials; Risk; Rosa; Safety; Seasons; Severe Adverse Event; Sinusitis; Site; Streptococcus pneumoniae; System; Third Pregnancy Trimester; Training; U-Series Cooperative Agreements; Vaccination; Vaccines; Virus Diseases; burden of illness; combat; data management; electronic data; evidence base; immunogenicity; infancy; infant outcome; influenza virus vaccine; influenzavirus; mortality; operation; pathogen; pregnant; premature; prevent; primary outcome; protective effect; public health relevance; respiratory; surveillance data; tool

DESCRIPTION (provided by applicant): Infections during pregnancy can cause serious illness in pregnant women and their infants and can have an adverse impact on fetal growth and development. Influenza virus is an important respiratory pathogen that causes substantial burden of disease - including morbidity and mortality among pregnant women and young infants. Moreover, risk of influenza-related morbidity is higher in pregnant women in their second and third trimesters compared to non-pregnant and postpartum women. Vaccination is the most effective tool for preventing morbidity and mortality due to influenza. The potential impact of maternal influenza immunization on maternal and infant outcomes has important clinical and public health implications. Better understanding of infant effects of maternal influenza immunization could provide an important tool to combat respiratory disease in early infancy -not only in developing countries but also in many developed and middle income countries as there is no influenza vaccine currently approved for use in infants younger than 6 months. Therefore, we propose to conduct a randomized, double-blind, controlled, vaccine trial in Guatemala. The trial will be conducted at field sites in the departments (administrative units) of Quetzaltenango in western Guatemala and Santa Rosa in southern Guatemala. The enrollment will be conducted over three years; incorporating three influenza seasons. We will evaluate efficacy and safety of maternal immunization with inactivated influenza vaccine in a) pregnant women (before and after delivery) and b) their infants. The primary outcome of the proposed trial is laboratory (rRT-PCR) confirmed influenza infection in infants younger than 6 months. The secondary infant/fetus outcomes include clinical influenza-like illness, prematurity, birth weight, delivery complications, pneumonia and severe pneumonia (per WHO Integrated Management of Childhood Illness classification), hospitalizations due to severe acute respiratory illness, and adverse and severe adverse events. Moreover, secondary maternal outcomes include laboratory (rRT-PCR) confirmed influenza infection, clinical influenza-like illness, delivery complication, hospitalizations due to severe acute respiratory illness, and adverse and severe adverse events. We will also evaluate immunogenicity of the inactivated influenza vaccine by hemagglutination inhibition assay and microneutralization assay; and will estimate transplacental transfer of maternal influenza antibodies, infant antibody levels, and half life of antibodies acquired passively by infants. PUBLIC HEALTH RELEVANCE: Influenza infection during pregnancy can cause serious illness in pregnant women and their infants. Vaccination is the most effective tool for preventing morbidity and mortality due to influenza. However, currently there is no approved vaccine for infants younger than 6 months. Potential impact of maternal influenza immunization on maternal and infant outcomes has important clinical and public health implications. Therefore, we propose to conduct a randomized, double-blind, controlled, vaccine trial in Guatemala to evaluate the efficacy of influenza immunization in pregnancy for protecting mothers and their infants.

描述（由申请人提供）：怀孕期间的感染可能导致孕妇及其婴儿出现严重疾病，并对胎儿的生长发育产生不利影响。流感病毒是一种重要的呼吸道病原体，会造成巨大的疾病负担，包括孕妇和婴儿的发病率和死亡率。此外，与非孕妇和产后妇女相比，妊娠中期和晚期的孕妇患流感相关发病的风险更高。 疫苗接种是预防流感发病和死亡的最有效工具。孕产妇流感免疫对孕产妇和婴儿结局的潜在影响具有重要的临床和公共卫生意义。更好地了解孕产妇流感免疫对婴儿的影响可以为对抗婴儿早期呼吸道疾病提供重要工具——不仅在发展中国家，而且在许多发达国家和中等收入国家，因为目前还没有批准用于 6 个月以下婴儿的流感疫苗。因此，我们建议进行随机、双盲、对照的疫苗试验 在危地马拉。试点在各部门（行政单位）实地进行 危地马拉西部的克萨尔特南戈和危地马拉南部的圣罗莎。报名将是 进行了三年多；包括三个流感季节。 我们将评估 a) 孕妇（分娩前和分娩后）和 b) 婴儿使用灭活流感疫苗进行母亲免疫的有效性和安全性。拟议试验的主要结果是实验室结果 (rRT-PCR) 证实 6 个月以下婴儿感染流感。第二婴儿/胎儿 结局包括临床流感样疾病、早产、出生体重、分娩并发症、肺炎和重症肺炎（根据世界卫生组织儿童疾病综合管理分类）、因严重急性呼吸道疾病住院以及不良事件和严重不良事件。此外，次要产妇结局包括实验室（rRT-PCR）确诊的流感感染、临床流感样疾病、分娩并发症、因严重急性呼吸道疾病住院以及不良和严重不良事件。我们还将通过血凝抑制试验和微量中和试验评价灭活流感疫苗的免疫原性；并将估计母体流感抗体的经胎盘转移、婴儿抗体水平以及婴儿被动获得的抗体的半衰期。 公共卫生相关性：怀孕期间感染流感可导致孕妇及其婴儿患严重疾病。 疫苗接种是预防流感发病和死亡的最有效工具。然而，目前还没有批准用于 6 个月以下婴儿的疫苗。孕产妇流感免疫对孕产妇和婴儿结局的潜在影响具有重要的临床和公共卫生意义。 因此，我们建议在危地马拉进行一项随机、双盲、对照疫苗试验，以评估妊娠期流感免疫对保护母亲及其婴儿的功效。