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.

多中心艾滋病队列研究/妇女机构间艾滋病毒研究联合队列研究 (MWCCS) 创新基金申请：Covide-19 疫苗接受情况

• 批准号: 10397365
• 负责人: Roger Detels
• 金额: $ 9.74万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-15 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10397365
• 关键词: Address; Age; Antibody titer measurement; Behavioral; COVID-19; COVID-19 vaccine; Characteristics; Cohort Studies; Data; Development; Disease; Disease Outbreaks; Economics; Effectiveness; Elderly; Ethnic Origin; Female; Funding; Future; HIV; HIV Infections; Health; Immune; Immune response; Immunization; Incidence; Individual; Infection; Investigation; Longitudinal observational study; Mediating; Methods; Participant; Population Control; Prevalence; Proteins; Race; Research; SARS-CoV-2 infection; Sampling; Serology; Specimen; Testing; The Multicenter AIDS Cohort Study; Time; Titrations; Vaccinated; Vaccination; Vaccines; Visit; Women' s Interagency HIV Study; base; comorbidity; high risk population; improved; innovation; male; protective effect; response; seroconversion; severe COVID-19; sex; social; vaccination strategy; vaccine acceptance; vaccine efficacy; vaccine hesitancy; virology

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.

项目摘要/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，他们势在必行 他们接种了新的新冠肺炎疫苗，这对他们的健康至关重要。然而，到目前为止，只有轶事 有关艾滋病病毒感染者(PWH)对新冠肺炎疫苗接受度和疗效的数据。MWCCS非常适合 分析(A)新冠肺炎疫苗(S)在男女生殖器疱疹及配型艾滋病病毒感染者中的接受度和效果 未感染对照(HUC)，(B)年龄和合并症对疫苗免疫反应的影响以及 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：选择不接种的男性和女性威尔斯亲王和胡克 新冠肺炎疫苗。我们为这项划桨创新提出的纵向观测研究的目标 应用：目标1：进行大规模、混合方法的流行情况调查， 新冠肺炎疫苗接种迟疑与MWCCS参与者之间的相关性和细微差别。结果将对我们有所帮助 为了更好地了解威尔斯亲王医院和中心人群对基于年龄的新冠肺炎疫苗的关注， 性别、种族/民族和潜在的共病负担。目标2：确定自然SARS的发病率- 威尔斯亲王医院新冠肺炎免疫后CoV-2感染与同龄、同性别、同年龄、同年龄、同性别、同年龄、同年龄、同性别、同年龄、 人种/种族；并比较接种疫苗个人的感染发生率与 未接种疫苗的个人感染。作为对预算限制的调整，我们将目标2限制为 在A组接种疫苗之前和可比的时间段内，在基线上获得一份样本 对于B组，在MWCCS核心访问期间收集的后续样本将用于血清学 分析。这些样本将使我们能够检测S和N蛋白，以确定血清学新冠肺炎 免疫前和免疫后血清转换情况。抗S抗体滴定后的结果 免疫将表明疫苗免疫反应，而抗N抗体滴度将表明自然SARS- 冠状病毒2型感染。这一信息将有助于识别无症状和有症状的个人。 接种后和未接种组均感染SARS-CoV-2。MWCCS中的感染 将允许有针对性地使用核心样本来深入研究疫苗的免疫机制- 突破性SARS-CoV-2的免疫应答和病毒学特征 感染情况，以及接种疫苗对潜在艾滋病毒感染的影响。