The impact of a Hepatitis B birth dose vaccine on HBV immunogenicity and incidence in children in the DRC

乙型肝炎出生剂量疫苗对刚果民主共和国儿童乙型肝炎免疫原性和发病率的影响

• 批准号: 10312874
• 负责人: Samantha Tulenko
• 金额: $ 3.85万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-01 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10312874
• 关键词: AIDS/HIV problem; Adopted; Africa South of the Sahara; African; Age; Age-Months; Asia; Birth; Blood; Categories; Cause of Death; Cessation of life; Child; Childbirth; Childhood; Childhood Acute Lymphocytic Leukemia; Chronic Hepatitis; Communicable Diseases; Communities; Data; Data Analyses; Democratic Republic of the Congo; Development; Disease; Doctor of Philosophy; Dose; Effectiveness; Epidemiologic Methods; Epidemiology; Fellowship; Future; Government; Grant; HIV; Health; Hepatitis B; Hepatitis B Antibodies; Hepatitis B Incidence; Hepatitis B Prevalence; Hepatitis B Transmission; Hepatitis B Vaccines; Horizontal Disease Transmission; Hour; Household; Immunity; Immunology; Incidence; Infant; Infant Health; Infection; Infectious Disease Epidemiology; Intervention; Intervention Studies; Knowledge; Life; Malaria; Measures; Mentors; Modeling; Morbidity - disease rate; Mothers; Newborn Infant; North Carolina; Physicians; Policies; Postdoctoral Fellow; Province; Randomized; Research; Schedule; Scientist; Series; Spottings; Training; Tuberculosis; Universities; Vaccinated; Vaccines; Vertical Disease Transmission; Viral hepatitis; burden of illness; career; cohort; epidemiological model; global health; immunogenicity; infant infection; interest; intervention program; markov model; mathematical model; member; mortality; prevent; protective efficacy; secondary analysis; skills; translational study; vaccination schedule; vaccinology

PROJECT SUMMARY Over the past few decades, viral hepatitis has become a leading cause of death globally, causing more deaths each year than malaria, HIV/AIDS, or tuberculosis. When considering Hepatitis B (HBV), this large burden of disease is largely driven by childhood infections, as 90% of infants infected with HBV will develop chronic hepatitis with lifelong sequelae. Childhood HBV infection occurs through vertical transmission (from mothers to children during childbirth) and through horizontal transmission (between members of the same household or community). In sub-Saharan Africa (SSA), where HBV remains endemic, children are vaccinated against HBV at 6, 10, and 14 weeks of age. This schedule does not protect against vertical transmission, and an estimated 1% of newborns (367,250 infants) in SSA continue to be infected with HBV at birth each year. Administration of the monovalent HBV vaccine at birth has been shown to have up to 95% protective efficacy against vertical transmission in the WHO Western Pacific region. However, few studies have been conducted to characterize the potential impact of providing a birth dose of HBV vaccine in sub-Saharan African settings. Our partners for this project, the Ministry of Health in the Democratic Republic of the Congo (DRC) are particularly interested in understanding whether to adopt a national HBV birth dose intervention. This translational study will provide estimates of the effectiveness and impact of a 4-dose HBV vaccine series (including a birth dose) in the DRC. The proposed research will utilize previously collected data and dried blood spots from two trials in Kinshasa Province, DRC: the Birth Dose Immunogenicity Study and the Continuous Quality Improvement Study. Using advanced epidemiological methods and mathematical modeling, this proposal aims to 1) compare the proportion of infants who achieve protective immunity to HBV at 12 months of age by vaccine dose series and mothers' HBV and HIV status and 2) model the impact of adopting a national 4-dose HBV vaccine series, including the birth dose, on the incidence of HBV in children under 5 in the DRC. The results will provide valuable estimates of the immunogenicity and potential impact of an HBV birth dose that will inform vaccine policy in the DRC and greater sub-Saharan African region. Through the completion of these research aims, the trainee will gain a unique set of skills in advanced epidemiologic methods, mathematical modeling, and vaccine intervention research. Expert mentors in vaccinology, immunology, modeling, and epidemiology will support the trainee's successful completion of the proposed research, associated training plan, and MD/PhD degree at the University of North Carolina at Chapel Hill. This F30 fellowship will aid the applicant's development as a future interdisciplinary physician-scientist practicing at the intersection of infectious disease, infant health, and interventional epidemiology.

项目摘要 在过去的几十年中，病毒肝炎已成为全球死亡的主要原因，导致更多死亡 每年都比疟疾，艾滋病毒/艾滋病或结核病。在考虑乙型肝炎（HBV）时，这很大的负担 疾病主要是由儿童感染驱动的，因为90％的感染HBV的婴儿会慢性发展 肝炎和终身后遗症。儿童HBV感染是通过垂直传播发生的（从母亲到 分娩期间的儿童）和通过横向传播（同一家庭成员之间或 社区）。在撒哈拉以南非洲（SSA），HBV仍处于特有的地方，儿童接种了HBV 在6、10和14周龄。该时间表不能防止垂直传输，估计 SSA中有1％的新生儿（367,250名婴儿）每年出生时继续感染HBV。管理 出生时单价HBV疫苗已显示出高达95％的防护功能 西太平洋地区的传播。但是，很少进行研究 表征在撒哈拉以南非洲提供HBV疫苗的出生剂量的潜在影响 设置。我们的该项目的合作伙伴，刚果民主共和国卫生部（DRC） 特别有兴趣了解是否采用国家HBV出生剂量干预。 这项翻译研究将估算4剂HBV疫苗系列的有效性和影响 （包括出生剂量）在DRC中。拟议的研究将利用先前收集的数据和干血 来自金沙萨省的两个试验的景点，刚果民主共和国：出生剂量免疫原性研究和连续的 质量改进研究。使用高级流行病学方法和数学建模， 提案的目的是1）比较12岁时获得保护性免疫力的婴儿的比例 疫苗剂量系列和母亲的HBV和艾滋病毒状况以及2）建模的影响 在HBV发病率上采用全国4剂HBV疫苗系列，包括出生剂量 刚果民主共和国5岁以下的儿童。结果将为免疫原性和潜力提供有价值的估计值 HBV出生剂量的影响将为刚果民主共和国和大撒哈拉以南非洲地区的疫苗政策提供依据。 通过完成这些研究目的，学员将获得一系列高级技能 流行病学方法，数学建模和疫苗干预研究。专家导师 疫苗接种，免疫学，建模和流行病学将支持学员成功完成 北卡罗来纳大学教堂大学的拟议研究，相关培训计划和医学博士学位 爬坡道。该F30奖学金将帮助申请人作为未来的跨学科医师科学家的发展 在传染病，婴儿健康和介入流行病学的交汇处进行实践。