Data Analysis and Coordination Center for the MACS-WIHS Combined Cohort Study

MACS-WIHS 联合队列研究数据分析和协调中心

• 批准号: 10392680
• 负责人: Gypsyamber D'Souza
• 金额: $ 1.63万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-09 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10392680
• 关键词: Address; Age; Antibody titer measurement; Behavioral; COVID-19; COVID-19 vaccine; Characteristics; Cohort Studies; Data; Data Analyses; Disease; Economics; Elderly; Ethnic Origin; FDA Emergency Use Authorization; Female; Funding; HIV; HIV Infections; Health; Immune; Immune response; Immunization; Incidence; Individual; Infection; Investigation; Longitudinal observational study; Mediating; Methods; Participant; Population Control; Prevalence; Proteins; Race; SARS-CoV-2 infection; Sampling; Serology; Specimen; Time; Titrations; Vaccinated; Vaccination; Vaccines; Visit; base; cohort; comorbidity; high risk population; innovation; male; response; seroconversion; severe COVID-19; sex; social; vaccine acceptance; vaccine efficacy; vaccine hesitancy; virology

Contact PD/PI: Rinaldo, Charles R ABSTRACT MWCCS participants are a high-risk group for severe COVID-19 disease in terms of being HIV-infected, predominately of elderly age, and having numerous underlying comorbidities. Therefore, it is imperative for their health that they be vaccinated with the new COVID-19 vaccines. To date, however, there are only anecdotal data on COVID-19 vaccine acceptance and efficacy in people with HIV (PWH). The MWCCS is ideal for analyzing (a) the acceptancy and effects of COVID-19 vaccine(s) in male and female PWH and matched HIV- uninfected controls (HUC), (b) the impact of age and co-morbidities on vaccine immune response and protection against COVID-19, and (c) the social, economic, and behavioral changes after COVID-19 immunization as compared to the individuals who opted to not take the vaccine. To address this issue, we will have 2 groups of MWCCS participants in this study: Group A: Male and female PWH and HUC who choose to receive a COVID-19 vaccine, Group B: Male and female PWH and HUC who choose NOT to receive a COVID-19 vaccine. The aims of our proposed longitudinal observational study for this OAR Innovation application are: Aim 1: To conduct an MWCCS-wide, mixed-methods investigation of the prevalence, correlates, and nuances of COVID-19 vaccine hesitancy among MWCCS participants. Results will help better understand the concerns of PWH and HUC populations regarding COVID-19 vaccines based on age, sex, race/ethnicity, and underlying comormidity burden. Aim 2: To determine the incidence of natural SARS-CoV-2 infections post-COVID-19 immunization in PWH as compared to HUC of the same age, sex, and ethnicity/race and also compare with the incidence of infections in non-vaccinated individuals. Because of budgetary limitations in the OAR Innovation Fund supplement, we will restrict Aim 2 to obtaining one specimen at baseline, just prior vaccination in Group A, and within comparable time periods for Group B. Subsequent samples collected during the core MWCCS visits will be used in the serological analyzes. These samples will allow us to determine the serological COVID-19 status pre-immunization, and post-immunization seroconversions for S and N proteins. The titration of anti-S responses post immunization will indicate vaccine immune response, while anti-N antibody titers will indicate natural SARS-CoV-2 infection. This will allow the identification of asymptomatic and symptomatic individuals infected with SARS-CoV-2 post-vaccination and in non-vaccinated group. The if these infections in the MWCCS will allow a targeted use of core samples in depth investigation of the immune mechanisms of vaccine-mediated protection, the immunologic responses and virologic characteristics of breakthrough SARS- CoV-2 infections, and the impact of the vaccination on underlying HIV infection. Importantly, timely funding from this OAR Innovation opportunity is critical to our addressing these aims prior to the broad rollout of the COVID-19 vaccines to our PWH participants. We are in a race to obtain this critical information and specimens prior to the wide availability of current FDA EUA vaccines to our MWCCS participants. Project Summary/Abstract Page 7

联系PD/PI：Rinaldo，Charles R 摘要 就感染艾滋病毒而言，MWCCS参与者是严重新冠肺炎疾病的高危人群， 主要是老年人，并有许多潜在的合并症。因此，他们势在必行 他们接种了新的新冠肺炎疫苗，这对他们的健康至关重要。然而，到目前为止，只有轶事 有关艾滋病病毒感染者(PWH)对新冠肺炎疫苗接受度和疗效的数据。MWCCS非常适合 分析(A)新冠肺炎疫苗(S)在男女特发性肝炎和配型HIV感染者中的接受性和效果 未感染对照(HUC)，(B)年龄和合并症对疫苗免疫反应和保护的影响 (C)新冠肺炎接种后的社会、经济和行为变化，如 与选择不接种疫苗的人相比。为了解决这个问题，我们将有两个小组， 本研究的MWCCS参与者：A组：男性和女性PWH和Huc，他们选择接受 新冠肺炎疫苗，B组：选择不接种新冠肺炎疫苗的男性和女性威尔斯亲王和胡克。 我们为这项划桨创新应用提出的纵向观察研究的目标是：目标1： 开展MWCCS范围的混合方法调查，以了解以下疾病的患病率、相关性和细微差别 MWCCS参与者中新冠肺炎疫苗接种的犹豫。结果将有助于更好地理解人们的担忧 基于年龄、性别、种族/民族和潜在危险因素的威斯康星和霍乱人群新冠肺炎疫苗接种情况 同质负担。目的2：确定新冠肺炎后SARS-CoV-2自然感染的发生率 威尔斯亲王医院与相同年龄、性别和人种/种族的中心的比较，以及与 未接种疫苗的个人的感染发生率。由于Oar创新中的预算限制 资金补充，我们将限制目标2在基线上只获得一个样本，只是在 A组，并在B组的可比时间段内，在岩芯期间采集的后续样品 MWCCS访问将用于血清学分析。这些样本将使我们能够确定 新冠肺炎状态为免疫前、免疫后血清转换为S和N蛋白。滴定 免疫后抗S抗体滴度表示疫苗免疫应答，而抗N抗体滴度表示疫苗免疫应答 表明是自然感染的SARS-CoV-2。这将允许识别无症状和有症状的 疫苗接种后和未接种组中SARS-CoV-2感染者。如果这些感染发生在 MWCCS将允许有针对性地使用核心样本来深入研究猪瘟的免疫机制 疫苗介导的保护、突破性SARS的免疫学反应和病毒学特征-- CoV-2感染，以及接种疫苗对潜在艾滋病毒感染的影响。重要的是，及时提供资金 从这一点来看，划桨创新机会对于我们在广泛推广之前实现这些目标至关重要 为威尔斯亲王医院的参与者提供新冠肺炎疫苗。我们正在竞相获取这一关键信息 在目前FDA EUA疫苗向我们的MWCCS参与者广泛提供之前。 项目摘要/摘要第7页