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.

项目总结/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（HUC），（B）年龄和共病对疫苗免疫应答的影响，和 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，他们选择 接种COVID-19疫苗，B组：选择不接种COVID-19疫苗的男性和女性威尔斯亲王医院和HUC COVID-19疫苗我们为这项OAR创新提出的纵向观察研究的目的是 目的1：对MWCCS范围内的患病率进行混合方法调查， MWCCS参与者之间COVID-19疫苗犹豫的相关性和细微差别。结果会帮助我们 为了更好地了解PWH和HUC人群对基于年龄的COVID-19疫苗的关注， 性别、种族/民族和潜在的合并症负担。目的2：确定SARS自然发病率- 与相同年龄、性别和年龄的HUC相比，PWH在COVID-19免疫接种后的CoV-2感染 种族/人种;并将接种疫苗个体的感染发生率与 未接种疫苗的人感染。作为对预算限制的调整，我们将把目标2限制在 在基线时、A组疫苗接种前即刻和可比时间段内采集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测试S和N蛋白，以确定血清学COVID-19 免疫前和免疫后的血清转化状况。抗S应答的滴定 免疫将指示疫苗免疫应答，而抗-N抗体滴度将指示天然SARS- CoV-2感染。这一信息将有助于识别无症状和有症状的个人 在接种疫苗后和未接种疫苗组中感染SARS-CoV-2。MWCCS中的感染 将允许有针对性地使用核心样本，以深入研究疫苗的免疫机制- 突破性SARS-CoV-2介导的保护、免疫应答和病毒学特征 感染，以及疫苗接种对潜在HIV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.