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.

摘要 就感染艾滋病毒而言，MWCCS参与者是严重新冠肺炎疾病的高危人群， 主要是老年人，并有许多潜在的合并症。因此，当务之急 他们为自己的健康接种了新的新冠肺炎疫苗。然而，到目前为止，只有 新冠肺炎疫苗在艾滋病患者中的接受度和有效性的轶事数据。MWCCS是理想的 为分析(A)新冠肺炎疫苗(S)在男女妇女和配对人群中的接受性和效果 艾滋病毒未感染对照(HUC)，(B)年龄和合并症对疫苗免疫反应的影响和 对新冠肺炎的保护，以及(C)新冠肺炎之后的社会、经济和行为变化 与选择不接种疫苗的个人进行比较。为了解决这个问题，我们将 本研究有两组MWCCS参与者：A组：男性和女性PWH和Huc，选择 接种新冠肺炎疫苗，B组：选择不接种COVID的男性和女性威尔斯亲王和胡克 19种疫苗。我们为这项划桨创新应用提出的纵向观测研究的目标是： 目标1：对MWCCS范围内的患病率、相关性和细微差别进行混合方法调查 MWCCS参与者中新冠肺炎疫苗接种迟疑的比例。结果将有助于更好地理解人们的担忧 基于年龄、性别、种族/民族和潜在危险因素的威斯康星和霍乱人群新冠肺炎疫苗接种情况 共病负担。目的2：确定新冠肺炎后SARS-CoV-2自然感染的发生率 威尔斯亲王医院与相同年龄、性别和人种/种族的中心的比较，以及与 未接种疫苗的个人的感染发生率。由于Oar创新中的预算限制 资金补充，我们将限制目标2在基线上只获得一个样本，只是在小组接种之前 A组和B组在可比时间段内，在核心MWCCS期间收集的后续样本 访问将用于血清学分析。这些样本将使我们能够确定血清学冠状病毒- 19免疫前、免疫后血清S和N蛋白阳转率。抗血凝素滴定 S免疫后应答表示疫苗免疫应答，而抗N抗体滴度表示疫苗免疫应答 自然感染SARS-CoV-2。这将允许识别无症状和有症状的个体。 接种后和未接种组均感染SARS-CoV-2。如果这些感染发生在 MWCCS将允许有针对性地使用核心样本来深入研究猪瘟的免疫机制 疫苗介导的保护、免疫应答和病毒学特征的突破 SARSCoV-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，及时 来自Oar创新机会的资金对于我们在广泛推广之前实现这些目标至关重要 为威尔斯亲王医院的参与者提供新冠肺炎疫苗。我们正在争先恐后地获取这些关键信息 在我们的MWCCS参与者广泛获得当前FDA EUA疫苗之前的样本。