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

摘要 MWCCS参与者是严重COVID-19疾病的高风险群体，因为他们感染了艾滋病毒， 主要是老年人，并有许多潜在的合并症。因此， 他们的健康，他们接种新的COVID-19疫苗。然而，到目前为止，只有 关于COVID-19疫苗在艾滋病毒感染者中的接受程度和有效性的轶事数据。MWCCS是理想的 分析（a）男女威尔斯亲王医院及配对病人对COVID-19疫苗的接受程度及效果 未感染HIV的对照（HUC），（B）年龄和共病对疫苗免疫应答的影响， 预防COVID-19;及（c）COVID-19后的社会、经济及行为变化 与选择不接种疫苗的人相比，为了解决这个问题，我们将 在这项研究中有两组MWCCS参与者：A组：男性和女性PWH和HUC， 选择接种COVID-19疫苗，B组：选择不接种疫苗的男女PWH和HUC 接种新冠疫苗我们提出的这项OAR纵向观察性研究的目的是 创新应用是：目标1：进行MWCCS范围内的混合方法调查， MWCCS参与者中COVID-19疫苗犹豫的患病率、相关因素和细微差别。 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/民族和潜在的共患病负担。目的2：确定 与同龄的HUC相比，PWH在COVID-19免疫接种后自然感染SARS-CoV-2， 性别和种族/人种，并与未接种疫苗个体的感染发生率进行比较。 由于OAR创新基金补充的预算限制，我们将目标2限制为获得 A组基线时、接种前即刻和接种后相当时间段内的1份标本 B组。在核心MWCCS访视期间采集的后续样本将用于血清学分析。 分析。这些样本将使我们能够确定免疫前的血清学COVID-19状态， 免疫后S和N蛋白的血清转化。免疫后抗S应答的滴定 将表明疫苗免疫应答，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无症状和有症状的SARS感染者- 接种后和未接种组中的CoV-2。如果MWCCS中的这些感染将允许 有针对性地使用核心样本，深入研究疫苗介导的 保护，免疫应答和突破性SARS-CoV-2感染的病毒学特征， 以及疫苗接种对潜在HIV感染的影响。重要的是，该业务成果办公室及时提供资金， 创新机会对于我们在COVID-19大范围推广之前实现这些目标至关重要- 为威尔斯亲王医院参与者提供19种疫苗。我们正在竞相获取这些重要的信息和标本 在当前FDA EUA疫苗广泛提供给我们的MWCCS参与者之前。MWCCS 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 因为资金是可用的，我们收到sIRB的批准。

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.