Surviving the HIV Epidemic (S/HE) in metropolitan Washington DC - Advancing knowledge through cohort studies

摘要 MWCCS参与者是严重新冠肺炎疾病的高危人群，就感染艾滋病毒而言- 感染的，主要是老年人，并有许多潜在的合并症。因此， 为了他们的健康，他们必须接种新的新冠肺炎疫苗。到目前为止， 然而，关于新冠肺炎疫苗在人群中的接受度和有效性的数据只是坊间数据 感染艾滋病毒(PWH)。MWCCS是分析(A)新冠肺炎的接受度和效果的理想工具 疫苗(S)在男性和女性威尔斯亲王和匹配的艾滋病毒非感染对照(HUC)中的影响，(B) 年龄和并存对疫苗免疫反应和对新冠肺炎的保护作用，以及 (C)与接种新冠肺炎相比，接种新冠肺炎后的社会、经济和行为变化 那些选择不接种疫苗的人。为了解决这个问题，我们将有两个小组 本研究的MWCCS参与者：A组：选择Pwh和Huc的男性和女性 接种新冠肺炎疫苗B组：选择不接种的男女威尔斯亲王和胡克 接种新冠肺炎疫苗。我们为此提出的纵向观测研究的目的 OAR的创新应用有：目标1：在MWCCS范围内进行混合方法 新冠肺炎疫苗迟滞的流行率、相关性和细微差别的调查 在MWCCS参与者中。结果将有助于更好地了解威尔斯亲王医院和Huc的关切 基于年龄、性别、种族/民族和潜在危险因素的新冠肺炎疫苗接种人群 同质负担。目的2：确定SARS-CoV-2自然感染的发病率。 威尔斯亲王医院与同龄、性别、民族/种族人群新冠肺炎免疫接种的比较 并与未接种疫苗的个人的感染发生率进行比较。因为. Oar创新基金补充资金的预算限制，我们将限制目标2以获得 一份样本在基线，A组之前接种过，在可比的时间内 B组的期间将使用在MWCCS核心访问期间收集的后续样本 在血清学分析中。这些样本将使我们能够确定血清新冠肺炎 S和N蛋白免疫前和免疫后血清转换情况。这个 免疫后抗S抗体滴定可提示疫苗免疫应答，而抗S抗体滴定则提示疫苗免疫应答。 N抗体滴度将指示自然感染SARS-CoV-2这一信息将使 SARS-CoV-2后无症状和有症状感染者的鉴定 接种疫苗组和未接种组。如果MWCCS中的这些感染将允许 有针对性地利用核心样本深入研究疫苗的免疫机制-- 突破性免疫应答和病毒学特征 SARS-CoV-2感染，以及疫苗接种对潜在艾滋病毒感染的影响。 重要的是，来自Oar创新机会的及时资金对我们的 在我们威尔斯亲王医院广泛推出新冠肺炎疫苗之前解决这些目标 参与者。我们正在争先恐后地获取这一关键信息和标本 向我们的MWCCS参与者广泛提供当前FDA EUA疫苗。MWCCS 美国各地的临床研究站点和数据中心都已准备好推出这一新的 一旦有资金可用，我们就进行研究，并获得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.