MACS/WIHS Combined Cohort Study: Cook County Clinical Research Site (CC_CRS)

MACS/WIHS 联合队列研究：库克县临床研究中心 (CC_CRS)

• 批准号: 10401710
• 负责人: Mardge H Cohen
• 金额: $ 3.13万
• 依托单位: HEKTOEN INSTITUTE FOR MEDICAL RESEARCH
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-01 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10401710
• 关键词: Address; Age; Antibody titer measurement; Behavioral; COVID-19; COVID-19 pandemic; COVID-19 vaccine; Characteristics; Cohort Studies; County; Data; 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; Protocols documentation; Public Health; Race; SARS-CoV-2 infection; Sampling; Serology; Specimen; Time; Titrations; United States; Vaccinated; Vaccination; Vaccines; Visit; base; clinical research site; comorbidity; cooking; coronavirus disease; data centers; design; high risk population; innovation; male; response; seroconversion; severe COVID-19; sex; social; vaccine acceptance; vaccine efficacy; vaccine hesitancy; virology

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 information 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. The MWCCS clinical research sites across the United States and the data center are ready to launch this new study as soon as funding is available and we receive sIRB approval.

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，当务之急 他们为自己的健康接种了新的新冠肺炎疫苗。然而，到目前为止，只有 新冠肺炎疫苗在艾滋病患者中的接受度和有效性的轶事数据。MWCCS是理想的 为分析(A)新冠肺炎疫苗(S)在男女妇女和配对人群中的接受性和效果 艾滋病毒未感染对照(HUC)，(B)年龄和合并症对疫苗免疫反应的影响和 对新冠肺炎的保护，以及(C)新冠肺炎之后的社会、经济和行为变化 与选择不接种疫苗的个人进行比较。为了解决这个问题，我们将 本研究有两组MWCCS参与者：A组：男性和女性PWH和Huc Who 选择接种新冠肺炎疫苗，B组：选择不接种的男女威尔斯亲王和胡克 接种新冠肺炎疫苗。我们提议对这一桨进行纵向观测研究的目的 创新的应用是：目标1：进行MWCCS范围内的混合方法调查 MWCCS参与者中新冠肺炎疫苗迟疑的流行率、相关性和细微差别。 结果将有助于更好地了解威尔斯亲王医院和中心人群对新冠肺炎疫苗的担忧 基于年龄、性别、种族/民族和潜在的共同负担。目标2：确定 威尔斯亲王医院新冠肺炎免疫后自然感染SARS-CoV-2与同龄人群的比较 并将其与未接种疫苗的个人的感染发生率进行比较。 由于OAR创新基金补充资金的预算限制，我们将限制目标2以获得 一份样本处于基线，仅在A组之前接种过疫苗，并在可比时间段内 B组在MWCCS核心访问期间收集的后续样本将用于血清学 分析。这些样本将使我们能够确定免疫前的新冠肺炎血清学状态，以及 免疫后S和N蛋白的血清转换。抗S免疫后效价的测定 将指示疫苗免疫反应，而抗N抗体滴度将指示自然感染SARS-CoV-2 这些资料将有助于识别感染SARS的无症状和有症状的个人- CoV-2疫苗接种后和未接种组。如果MWCCS中的这些感染将允许 靶向利用核心样本深入研究疫苗介导的免疫机制 SARS-CoV-2突破性感染的免疫应答和病毒学特征， 以及接种疫苗对潜在艾滋病毒感染的影响。重要的是，来自这艘桨的及时资金 创新机会对于我们在COVID广泛推出之前实现这些目标至关重要- 19支疫苗给我们的威尔斯亲王医院的参与者。我们正在竞相获取这一关键信息和标本 在我们的MWCCS参与者广泛获得当前FDA EUA疫苗之前。MWCCS 全美各地的临床研究站点和数据中心都准备好尽快推出这项新研究 由于资金可用，我们获得了SIRB的批准。