Innovation Fund Application to the Multicenter AIDS Cohort Study/Women's Interagency HIV Study Combined Cohort Study (MWCCS): Covide-19 vaccine Acceptance & Hesitancy (CVBH) Study in People with HIV.

项目概要/摘要 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，他们势在必行 确保他们接种新的 COVID-19 疫苗。但迄今为止，只有轶事 有关 HIV 感染者 (PWH) 的 COVID-19 疫苗接受度和功效的数据。 MWCCS 非常适合 分析 (a) 男性和女性 PWH 以及匹配的 HIV-19 疫苗的接受度和效果 未感染对照（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 接受 COVID-19 疫苗，B 组：选择不接受疫苗接种的男性和女性 PWH 和 HUC COVID-19 疫苗。我们为 OAR 创新提出的纵向观察研究的目的 应用程序是： 目标 1：对 MWCCS 范围内的患病率进行混合方法调查， MWCCS 参与者对 COVID-19 疫苗犹豫的相关性和细微差别。结果将帮助我们 为了更好地了解 PWH 和 HUC 人群对基于年龄的 COVID-19 疫苗的担忧， 性别、种族/民族和潜在的合并症负担。目标 2：确定自然 SARS 的发病率 与相同年龄、性别和年龄的 HUC 相比，PWH 中 COVID-19 免疫后的 CoV-2 感染情况 民族/种族；并将接种疫苗的个体的感染发生率与 未接种疫苗的个体中的感染。作为预算限制的调整，我们将目标 2 限制为 在 A 组接种疫苗之前，在可比较的时间段内，在基线时获取一份样本 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测试 S 和 N 蛋白，以确定血清学 COVID-19 免疫前和免疫后血清转化的状况。抗S反应后的滴定 免疫接种将表明疫苗免疫反应，而抗 N 抗体滴度将表明天然 SARS- CoV-2 感染。这些信息将有助于识别无症状和有症状的个体 接种疫苗后和未接种疫苗的组中感染了 SARS-CoV-2。 MWCCS 中的感染 将允许有针对性地使用核心样本来深入研究疫苗的免疫机制 介导的保护、突破性 SARS-CoV-2 的免疫反应和病毒学特征 感染，以及疫苗接种对潜在艾滋病毒感染的影响。

Project Summary/Abstract MWCCS participants are a high-risk group for severe COVID-19 disease in terms of being HIV-infected, predominately elderly, 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 acceptance 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 a MWCCS-wide, mixed-methods investigation of the prevalence, correlates, and nuances of COVID-19 vaccine hesitancy among MWCCS participants. The results will help us to better understand the concerns of PWH and HUC populations regarding COVID-19 vaccines based on age, sex, race/ethnicity, and underlying comorbidity 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 to compare the incidence of infections in vaccinated individuals with the incidence of infections in non-vaccinated individuals. As an adjustment for budgetary limitations, we will restrict Aim 2 to obtaining one specimen at baseline, just prior to 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 analyses. These samples will allow us to test for S and N proteins to determine the serological COVID-19 status in pre-immunization and post-immunization seroconversions. 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 the non-vaccinated group. The infections in the MWCCS will allow a targeted use of core samples for in depth investigations 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.