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.

抽象的 MWCCS 参与者是感染 HIV 的严重 COVID-19 疾病的高危人群， 主要是老年人，并且有许多潜在的合并症。因此，当务之急是 为了他们的健康，他们必须接种新的 COVID-19 疫苗。然而迄今为止，只有 有关 HIV 感染者 (PWH) 的 COVID-19 疫苗接受度和功效的轶事数据。 MWCCS 是理想的选择 用于分析 (a) COVID-19 疫苗在男性和女性感染者和匹配人群中的接受度和效果 未感染 HIV 的对照 (HUC)，(b) 年龄和合并症对疫苗免疫反应的影响和 预防 COVID-19，以及 (c) COVID-19 后的社会、经济和行为变化 与选择不接种疫苗的个体相比，免疫接种情况。为了解决这个问题，我们将 本研究有 2 组 MWCCS 参与者： A 组：男性和女性 PWH 和 HUC 选择接种 COVID-19 疫苗，B 组：选择不接种的男性和女性 PWH 和 HUC 接种 COVID-19 疫苗。我们为该 OAR 提出的纵向观察研究的目的 创新应用是： 目标 1：对 MWCCS 范围内的混合方法进行调查 MWCCS 参与者对 COVID-19 疫苗犹豫的患病率、相关性和细微差别。 结果将有助于更好地了解 PWH 和 HUC 人群对 COVID-19 疫苗的担忧 基于年龄、性别、种族/民族和潜在的共病负担。目标 2：确定发生率 与同龄 HUC 相比，PWH 中 COVID-19 免疫后的自然 SARS-CoV-2 感染， 性别和民族/种族，并与未接种疫苗的个体的感染发生率进行比较。 由于 OAR 创新基金补助的预算限制，我们将目标 2 限制为获得 基线时的一份样本，A 组之前接种疫苗，并且在可比较的时间段内 B 组。在 MWCCS 核心访问期间收集的后续样本将用于血清学检测 分析。这些样本将使我们能够确定免疫前的 COVID-19 血清学状态，以及 S 和 N 蛋白的免疫后血清转化。免疫后抗S反应的滴定 将表明疫苗免疫反应，而抗 N 抗体滴度将表明自然 SARS-CoV-2 感染 这些信息将有助于识别感染 SARS 的无症状和有症状的个体 疫苗接种后和未接种疫苗组中的 CoV-2。如果 MWCCS 中的这些感染将允许 针对性利用核心样本深入研究疫苗介导的免疫机制 突破性 SARS-CoV-2 感染的保护、免疫反应和病毒学特征， 以及疫苗接种对潜在艾滋病毒感染的影响。重要的是，OAR 及时提供资金 创新机会对于我们在新冠疫情广泛推广之前实现这些目标至关重要 为我们的 PWH 参与者提供 19 种疫苗。我们正在竞相获取这些关键信息和样本 在向我们的 MWCCS 参与者广泛提供当前 FDA EUA 疫苗之前。 MWCC 美国各地的临床研究中心和数据中心已准备好尽快启动这项新研究 因为资金到位并且我们获得了 SIRB 的批准。