Antibody persistence after conjugate meningococcal group A vaccination in Mali

马里 A 组结合型脑膜炎球菌疫苗接种后抗体持续存在

• 批准号: 8914178
• 负责人: Nicole Elaine Basta
• 金额: $ 10.01万
• 依托单位: PRINCETON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-20 至 2015-01-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8914178
• 关键词: Address; African; Age; Antibodies; Antibody Formation; Blood specimen; Burkina Faso; Clinical Trials; Country; Data; Data Analyses; Data Collection; Disease; Disease Outbreaks; Dose; Epidemic; Future; Goals; Health protection; Immune response; Immunity; Immunoglobulin G; Individual; Life; Mali; Mass Vaccinations; Meningitis; Meningococcal meningitis; Meningococcal vaccine; Morbidity - disease rate; Neisseria meningitidis; Niger; Nutritional status; Participant; Polysaccharides; Population; Prevention; Prevention strategy; Preventive; Public Health; Questionnaires; Recording of previous events; Research Design; Risk Factors; Sampling; Seasons; Serum; Socioeconomic Status; Statistical Methods; Target Populations; Time; United Kingdom; Universities; Vaccination; Vaccines; Washington; age group; aged; bactericide; base; clinically significant; design; immunogenicity; low socioeconomic status; mortality; novel vaccines; pathogen; population based; prevent; prospective; response; success; vaccin protein; vaccination strategy

PROJECT SUMMARY/ABSTRACT Meningitis epidemics, primarily caused by N. meningitidis serogroup A, occur annually during the dry season in the African meningitis belt, leading to significant morbidity and mortality among the 450 million people living in this region. The introduction of MenAfriVac, a newly developed conjugate meningococcal serogroup A vaccine, in Burkina Faso, Mali, and Niger in December 2010 was the first ever population-based, preventive mass-vaccination campaign against meningococcal meningitis in the meningitis belt and the first- ever nationwide use of this vaccine. While clinical trials have demonstrated that MenAfriVac induces a stronger immune response than polysaccharide meningococcal serogroup A vaccines, the duration of protection provided by MenAfriVac is currently unknown. The persistence of the serogroup A-specific serum bactericidal antibody (SBA) response and the IgG response, both accepted correlates of protection against invasive disease, are key determinants of whether the MenAfriVac mass-vaccination campaign will successfully prevent the deadly epidemics of meningitis that have occurred in the region for the past century. Our goal is to address a critical barrier to progress in the field by evaluating the impact of the MenAfriVac mass-vaccination campaign. Specifically, we will assess the duration of protection provided by the vaccine up to five years after the population-based, mass-vaccination campaign targeted to all individuals aged 1-29 years in Bamako, Mali. We will determine when, if at all, population-level immunity begins to wane up to five years after mass- vaccination. Additionally, we will determine the most effective vaccination strategy, which can then be implemented both in Mali and other countries of the African meningitis belt in the future. We will evaluate the antibody persistence following the MenAfriVac mass-vaccination campaign by collecting prospective immunogenicity data from a random sample of 800 residents of Bamako, Mali, aged 1- 29 years at 18 months, 36 months, and 54 months after mass vaccination. Specifically, we aim to: 1.) determine the proportion of individuals with protective levels of serogroup A-specific SBA and IgG both overall and by age at each of the three post-vaccination time points, 2.) evaluate the significance of temporal changes in serogroup A-specific SBA and IgG titers both overall and by age up to five years post-vaccination, and 3.) assess potential risk factors, such as age at vaccination, prior polysaccharide meningococcal vaccination, nutritional status, and socioeconomic status, for low SBA and IgG titers at each of the three post-vaccination time points. Statistical methods will be used to provide evidence for the degree of vaccine-induced antibody persistence and to evaluate risk factors for low antibody response. The results will be used to develop and implement the most effective vaccination strategy in the countries of the African meningitis belt, to determine if there is a need for additional booster doses of vaccine in any age group after five years, and to increase our understanding of the mechanism by which MenAfriVac provides protection against invasive disease.

项目摘要/摘要 脑膜炎流行病主要由脑膜炎链球菌血清群A引起，每年在干燥期间发生 非洲脑膜炎带的季节，导致4.5亿 居住在这个地区的人们。梅纳弗瓦克（Menafrivac）的引入是新开发的共轭脑膜炎球菌 2010年12月，在布基纳法索，马里和尼日尔的血清群疫苗是有史以来第一个以人群为基础的 脑膜炎带和第一个预防性大量疫苗接种运动针对脑膜炎球菌脑膜炎和第一 曾经在全国范围内使用这种疫苗。虽然临床试验表明，梅纳弗瓦克（Menafrivac）诱导了更强的 免疫反应比多糖脑膜炎球菌血清群A疫苗，保护持续时间 Menafrivac提供的目前未知。血清群特异性血清杀菌的持久性 抗体（SBA）响应和IgG响应，两者都接受保护的相关性 疾病，是Menafrivac大规模疫苗接种运动的关键决定因素 脑膜炎的致命流行病是在过去一个世纪中发生的。我们的目标是解决 通过评估MENAFRIVAC群众疫苗接种的影响，在现场进步的关键障碍 活动。具体而言，我们将评估疫苗在五年后提供的疫苗提供的保护持续时间 基于人群的大规模疫苗接种运动针对马里巴马科（Bamako）的所有1-29岁的人。 我们将确定何时，如果何时，在群众质量之后，人口级免疫力最多开始减少五年 疫苗接种。此外，我们将确定最有效的疫苗接种策略，然后可以 将来在马里和其他非洲脑膜炎带的其他国家实施。 我们将评估Menafrivac大规模疫苗接种运动之后的抗体持久性 从Mali的Bamako的800名居民的随机样本中收集前瞻性免疫原性数据，1- 大规模疫苗接种后18个月，36个月和54个月的29年。具体来说，我们的目标是：1。） 确定具有保护性血清群A特异性SBA和IgG的个体的比例 在三个疫苗接种后时间点的每个年龄中，2。）评估时间变化的重要性 在血清群特异性的SBA和IgG滴度中，疫苗接种后的五年和年龄均达到3年。 评估潜在的危险因素，例如疫苗接种时的年龄，先前的多糖脑膜炎球菌疫苗接种， 在三个疫苗接种后的每一个中，每个人的营养状况和社会经济状况，用于低SBA和IgG滴度 时间点。统计方法将用于提供疫苗诱导抗体程度的证据 持久性并评估低抗体反应的危险因素。结果将用于开发和 在非洲脑膜炎带的国家实施最有效的疫苗接种策略，以确定是否是否 五年后，任何年龄段的疫苗需要额外的促进剂量，并增加我们的疫苗 了解Menafrivac提供防止侵入性疾病的机制的理解。