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

联系PD/PI：Rinaldo，Charles R 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，他们必须 新冠肺炎疫苗的接种。然而，迄今为止， 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数据。MWCCS是理想的 分析（a）新型冠状病毒疫苗在男性和女性威尔斯亲王医院及配对的爱滋病病毒感染者中的接受程度和效果- 未感染对照组（HUC），（B）年龄和合并症对疫苗免疫应答和保护的影响 以及（c）COVID-19免疫接种后的社会、经济和行为变化， 与那些选择不接种疫苗的人相比。为了解决这个问题，我们将有两组 本研究的MWCCS参与者：A组：选择接受 COVID-19疫苗，B组：选择不接种COVID-19疫苗的男女PWH和HUC。 我们为OAR创新应用提出的纵向观察性研究的目的是：目的1： 进行MWCCS范围内的，混合方法调查的患病率，相关性，和细微差别， MWCCS参与者对COVID-19疫苗的犹豫。结果将有助于更好地了解问题 根据年龄、性别、种族/民族和基础疾病， 共同负担目的2：确定COVID-19后自然SARS-CoV-2感染的发病率 与同年龄、性别和种族的家庭主妇相比，以及与 未接种疫苗者的感染率。由于OAR创新的预算限制， 基金补充，我们将限制目标2在基线时获得一个样本， A组，以及B组的可比时间段内。在取芯期间采集的后续样本 MWCCS访视将用于血清学分析。这些样本可以让我们确定 免疫前COVID-19状态，以及免疫后S和N蛋白的血清转化。滴定 免疫后的抗-S应答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。这将允许识别无症状和有症状的 SARS-CoV-2疫苗接种后和未接种组的感染者。如果这些感染发生在 MWCCS将允许有针对性地使用核心样本，深入研究免疫机制， 疫苗介导的保护，免疫应答和突破性SARS的病毒学特征， CoV-2感染，以及疫苗接种对潜在HIV感染的影响。重要的是，及时提供资金 从这个OAR创新机会是至关重要的，我们解决这些目标之前，广泛推出 为威尔斯亲王医院的参与者提供新冠疫苗。我们正在竞相获取这一关键信息 在当前FDA EUA疫苗广泛提供给MWCCS参与者之前， 项目摘要/摘要第7页

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