MACS/WIHS Combined Cohort Study: Brooklyn Clinical Research Site (Bklyn CRS): COVID-19 Vaccine Acceptance and Hesitancy (CVHB) Study in People with HIV Supplement

MACS/WIHS 联合队列研究：布鲁克林临床研究中心 (Bklyn CRS)：HIV 补充剂人群的 COVID-19 疫苗接受和犹豫 (CVHB) 研究

• 批准号: 10396763
• 负责人: DEBORAH R. GUSTAFSON
• 金额: $ 3.94万
• 依托单位: SUNY DOWNSTATE MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-01 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10396763
• 关键词: Address; Age; Antibody titer measurement; Behavioral; COVID-19; COVID-19 vaccine; Characteristics; Cohort Studies; Data; Disease; Economics; Elderly; Ethnic Origin; FDA Emergency Use Authorization; Female; Funding; HIV; HIV Infections; Health; Immune; Immune response; Immunization; Incidence; Individual; Infection; Investigation; Longitudinal observational study; Mediating; Methods; Participant; Population Control; Prevalence; Proteins; Race; SARS-CoV-2 infection; Sampling; Serology; Specimen; Time; Titrations; Vaccinated; Vaccination; Vaccines; Visit; base; clinical research site; cohort; comorbidity; high risk population; innovation; male; response; seroconversion; severe COVID-19; sex; social; vaccine acceptance; vaccine efficacy; vaccine hesitancy; virology

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 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 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 SARSCoV-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.

抽象的 MWCC参与者是严重Covid-19的高风险组，就艾滋病毒感染而言， 主要是老年时代，并且具有许多潜在的合并症。因此，必须 他们的健康状况是通过新的Covid-19疫苗接种疫苗。但是，迄今为止，只有 有关HIV患者（PWH）的Covid-19疫苗接受和功效的轶事数据。 MWCC是理想的 用于分析（a）男性和女性PWH中covid-19疫苗的接受和影响并匹配 HIV未感染的对照（HUC），（b）年龄和合并症对疫苗免疫反应的影响 防止Covid-19，以及（c）Covid-19之后的社会，经济和行为变化 与选择不接种疫苗的个体相比，免疫接种。为了解决这个问题，我们将 本研究中有2组MWCC参与者：A组：男性和女性PWH和HUC，他们选择 接受Covid-19疫苗B组B组：男性和女性PWH和HUC，他们选择不接受Covid- 19疫苗。我们提出的针对此OAR创新应用的纵向观察性研究的目的是： 目的1：进行MWCCS范围内，对患病率的混合方法调查，相关性和细微差别 MWCC参与者的Covid-19-19疫苗犹豫。结果将有助于更好地了解关注点 根据年龄，性别，种族/种族和基础 合并症负担。目的2：确定COVID后自然SARS-COV-2感染的发生率19 与同一年龄，性别和种族/种族的HUC相比，PWH的免疫接种，也与 未接种疫苗的个体感染的发生率。由于OAR创新的预算限制 基金补充，我们将限制AIM 2在基线时获得一个标本，仅在小组中疫苗接种 A，在B组的相当时间内，在核心MWCC期间收集的随后样品 访问将用于血清学分析。这些样品将使我们能够确定血清学互联 19状态前免疫和S和N蛋白的免疫后血清转化。抗滴定 免疫后的S反应表示疫苗免疫反应，而抗N抗体滴度将表明 天然SARS-COV-2感染。这将允许识别无症状和有症状的个体 感染了SARS-COV-2疫苗接种后和非接种疫苗的组。如果这些感染 MWCC将允许对核心样品进行有针对性的使用，以深入研究 疫苗介导的保护，突破的免疫反应和病毒学特征 SARSCOV-2感染以及疫苗接种对潜在HIV感染的影响。重要的是，及时 从这个桨创新机会中获得的资金对于我们在广泛推出之前解决这些目标至关重要 我们的PWH参与者的Covid-19疫苗。我们正在竞争获得这些关键信息， 在我们的MWCC参与者提供当前FDA EUA疫苗的广泛可用性之前的标本。