Innovation Fund Application to the Multicenter AIDS Cohort Study MACS/Women's Interagency HIV Study WIHS Combined Cohort Study-MWCCS: COVID-19 Vaccine Acceptance and Hesitancy (CVHB) Study in People w

创新基金申请多中心艾滋病队列研究 MACS/妇女机构间艾滋病毒研究 WIHS 联合队列研究-MWCCS：人群中的 COVID-19 疫苗接受和犹豫 (CVHB) 研究

• 批准号: 10391742
• 负责人: MIRJAM-COLETTE KEMPF
• 金额: $ 3.36万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 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/10391742
• 关键词: AIDS/HIV problem; Address; Age; Antibody titer measurement; Behavioral; COVID-19; COVID-19 vaccine; Cohort Studies; Data; Disease; Economics; Elderly; Ethnic Origin; Female; Funding; HIV; Health; Immune response; Immunization; Incidence; Individual; Infection; Investigation; Longitudinal observational study; Methods; Participant; Population Control; Positioning Attribute; Prevalence; Proteins; Race; Recording of previous events; Research; SARS-CoV-2 infection; Sampling; Serology; Site; Specimen; The Multicenter AIDS Cohort Study; Time; Titrations; Vaccinated; Vaccination; Vaccines; Visit; Woman; Women' s Interagency HIV Study; base; comorbidity; high risk population; innovation; male; men; response; seroconversion; severe COVID-19; sex; social; vaccine acceptance; vaccine efficacy; vaccine hesitancy

PROJECT SUMMARY 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 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 will not take the vaccine. To address this issue, we will have two groups of MWCCS participants: 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 are: Aim 1: To conduct a mixed-methods investigation of the prevalence, correlates, and nuances of COVID-19 vaccine hesitancy among MWCCS participants. Results will help 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 compare with the incidence of infections in non- vaccinated individuals. 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.

项目摘要 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， 为他们的健康接种COVID-19疫苗。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 与不接种疫苗的人相比，为了解决这个问题，我们将 两组参与者：A组：男性和女性PWH和HUC，他们选择接受 COVID-19疫苗，B组：选择不接种COVID-19疫苗的男女PWH和HUC 疫苗我们提出的纵向观察研究的目的是：目的1：进行混合方法 调查2019冠状病毒病疫苗犹豫的患病率、相关因素和细微差别， MWCCS参与者。结果将有助于了解PWH和HUC人群对以下问题的关注： COVID-19疫苗基于年龄、性别、人种/种族和潜在的合并症负担。目标2： 确定威尔斯亲王医院接种COVID-19疫苗后自然感染SARS-CoV-2的发病率， 相同年龄、性别和种族/人种的HUC，并与非HUC感染的发生率进行比较。 接种疫苗的人。我们将目标2限制为在基线时获得一份标本， A组在接种疫苗期间，B组在相当的时间段内。随后采集的样本 在核心MWCCS访视期间，将在血清学分析中使用。这些样本可以让我们 确定免疫前和免疫后S的血清学COVID-19状态 N蛋白质。免疫后抗S应答的滴定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。这些信息将允许 在疫苗接种后和接种后发现SARS-CoV-2感染的无症状和有症状个体 未接种疫苗组。