Innovation Fund Application to the Multicenter AIDS Cohort Study (MACS)/Womens Interagency HIV Study (WIHS) Combined Cohort Study (MWCCS): COVID-19 Vaccine Acceptance and Hesitancy (CVHB)

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

• 批准号: 10397893
• 负责人: MARIA LUISA ALCAIDE
• 金额: $ 3.38万
• 依托单位: UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
• 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/10397893
• 关键词: 2019-nCoV; Address; Advisory Committees; Age; Aging; Antibody titer measurement; Attenuated; Awareness; Behavioral; Black race; CD4 Positive T Lymphocytes; COVID-19; COVID-19 pandemic; COVID-19 vaccination; COVID-19 vaccine; Cell Count; Centers for Disease Control and Prevention (U.S.); Characteristics; Chills; Chronic; Clinical; Cohort Studies; Communication; Complement; Coughing; Counseling; DNA; Data; Development; Diagnosis; Disease; Economics; Elderly; Eligibility Determination; Enrollment; Ethnic Origin; FDA Emergency Use Authorization; Female; Fever; Foundations; Funding; Future; Gender; HIV; HIV Infections; Headache; Health; Health Personnel; Health care facility; Immune; Immune response; Immunization; Immunization Programs; Immunize; Immunocompromised Host; Incidence; Individual; Infection; Investigation; Logistic Regressions; Long-Term Care; Longitudinal observational study; Measures; Mediating; Medical; Medical Records; Methods; Monitor; Myalgia; Participant; Patient Self-Report; Persons; Pfizer-BioNTech COVID-19 vaccine; Phase; Population Control; Prevalence; Principal Investigator; Proteins; Protocols documentation; Public Health; Race; Reporting; SARS-CoV-2 infection; SARS-CoV-2 positive; Sampling; Serology; Shortness of Breath; Slide; Smell Perception; Social status; Specimen; Sum; Surveys; Symptoms; Taste Perception; Testing; The Multicenter AIDS Cohort Study; Time; Titrations; Trust; United States; Vaccinated; Vaccination; Vaccines; Visit; Women' s Interagency HIV Study; adjudication; aged; base; clinical research site; common symptom; comorbidity; coronavirus disease; data centers; design; disease phenotype; efficacy clinical trial; follow-up; high risk population; innovation; instrument; male; meetings; response; seroconversion; severe COVID-19; sex; social; vaccine acceptance; vaccine efficacy; vaccine hesitancy; vaccine safety; vaccine trial; virology

COVID Vaccine Study Supplement to MWCCS Principal Investigators: C. Rinaldo and J. Martinson 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 with HIV Abstract and Specific Aims 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.

MWCCS主要研究者的COVID疫苗研究补充：C。里纳尔多和J·马丁森 多中心艾滋病队列研究（MACS）/妇女创新基金申请 机构间HIV研究（WIHS）联合队列研究（MWCCS）：COVID-19疫苗接受 艾滋病毒感染者的犹豫和犹豫（CVHB）研究 抽象和具体目标 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，当务之急是 为了他们的健康，他们应该接种新的COVID-19疫苗。然而，迄今为止， 只有关于COVID-19疫苗在艾滋病毒感染者（PWH）中接受和有效性的轶事数据。的 MWCCS是分析（a）COVID-19疫苗在男性和女性中的接受性和效果的理想工具 PWH和匹配的HIV未感染对照（HUC），（B）年龄和合并症对疫苗的影响 免疫反应和对COVID-19的保护，以及（c）社会，经济和行为 与选择不接种疫苗的个体相比，COVID-19免疫接种后的变化。 为了解决这个问题，我们将有2组MWCCS参与者参与本研究：A组：男性 以及选择接种COVID-19疫苗的女性PWH和HUC，B组：男性和女性 威尔斯亲王医院及胡志明市医院选择不接种COVID-19疫苗。我们提出的纵向目标 本OAR创新应用的观察性研究是：目标1：进行MWCCS范围内的混合- 方法调查COVID-19疫苗犹豫的患病率、相关因素和细微差别 MWCCS参与者调查结果将有助进一步了解威尔斯亲王医院及人类福祉委员会的关注事项 基于年龄、性别、人种/种族和潜在共病的COVID-19疫苗相关人群 负担目的2：确定COVID-19后自然SARS-CoV-2感染的发病率 与相同年龄、性别和种族/人种的HUC相比， 与未接种疫苗个体的感染发生率有关。由于预算有限， OAR创新基金补充，我们将限制目标2在基线时获得一个样本， A组中既往接种疫苗，B组中在可比时间段内。后续 在核心MWCCS访视期间采集的样本将用于血清学分析。这些样品 将使我们能够确定免疫前和免疫后的血清学COVID-19状态 S和N蛋白的血清转化。免疫后抗S应答的滴定将表明 疫苗的免疫反应，而抗N抗体滴度将表明自然SARS-CoV-2感染。 信息将有助于识别无症状和有症状的SARS感染者- 接种后和未接种组中的CoV-2。如果MWCCS中的这些感染将允许 有针对性地使用核心样本，深入研究疫苗介导的 突破性SARS-CoV-2的保护作用、免疫反应和病毒学特征 感染，以及疫苗接种对潜在HIV感染的影响。重要的是，及时提供资金 从这个OAR创新机会是至关重要的，我们解决这些目标之前，广泛的 为威尔斯亲王医院参与者推出新型冠状病毒疫苗。我们正在努力获得这个关键的 在当前FDA EUA疫苗广泛提供给我们之前， MWCCS参与者。美国各地的MWCCS临床研究中心和数据中心 我们已经准备好启动这项新的研究，一旦资金到位，我们收到sIRB批准。