Surviving the HIV Epidemic (S/HE) in metropolitan Washington DC - Advancing knowledge through cohort studies

在华盛顿特区大都市的艾滋病毒流行 (S/HE) 中生存 - 通过队列研究增进知识

基本信息

批准号：
10392681
负责人：
SEBLE G KASSAYE
金额：
$ 3.51万
依托单位：
GEORGETOWN UNIVERSITY
依托单位国家：
美国
项目类别：
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/10392681
关键词：
2019-nCoV AIDS clinical trial group Acquired Immunodeficiency Syndrome Address Advisory Committees Age Aging American Antibody titer measurement Asians Attenuated Awareness Behavioral Black race Body mass index CD4 Positive T Lymphocytes COVID-19 COVID-19 pandemic COVID-19 test COVID-19 treatment COVID-19 vaccination COVID-19 vaccine Cardiovascular system Cell Count Centers for Disease Control and Prevention (U.S.)Cessation of life Characteristics Chicago Chronic Clinical Code Cohort Studies Communication Complement Counseling Data Development Diabetes Mellitus Diagnosis Disease District of Columbia Dyslipidemias Economics Elderly Eligibility Determination England Enrollment Epidemic Ethnic Origin FDA Emergency Use Authorization Female Foundations Funding Future Gender HIV HIV Infections HIV Seronegativity HIV Vaccine Trials Network Health Health Personnel Health care facility Hispanics Human Papilloma Virus Vaccine Hypertension Immune Immune response Immunization Immunization Programs Immunize Immunocompromised Host Incidence Individual Infection Infection Control Influenza Influenza A Virus, H1N1 Subtype Investigation Kidney Diseases Knowledge Long-Term Care Longitudinal observational study Lung Malignant Neoplasms Measles Measles-Mumps-Rubella Vaccine Measures Mediating Medical Medical Records Methods Misinformation Moderna COVID-19 vaccine Monitor Morbidity - disease rate Nucleosides Obesity Participant Patient Self-Report Persons Pfizer-BioNTech COVID-19 vaccine Phase Population Population Control Prevalence Principal Investigator Proteins Protocols documentation Public Health RNA vaccine Race Recording of previous events Research Risk SARS-CoV-2 infection SARS-CoV-2 positive SARS-CoV-2 spike protein Safety Sampling Serology Services Severities Slide Smoking Social status Specimen Sum Surveys Symptoms Time Titrations Trust United States United States National Institutes of Health Universities Vaccinated Vaccination Vaccines Visit Woman adjudication aged antiretroviral therapy base clinical research site cohort comorbidity coronavirus disease data centers design disease phenotype distrust efficacy clinical trial ethnic diversity flu follow-up global health high risk population immunogenic innovation instrument lipid nanoparticle male meetings men metropolitan mortality mortality risk pandemic disease prevent protective effect racial and ethnic racial diversity receptor binding response seroconversion severe COVID-19 sex social social media surveillance study treatment response vaccine acceptance vaccine access vaccine efficacy vaccine hesitancy vaccine safety vaccine trial virology

项目摘要

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 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.

抽象的就 HIV 感染而言，MWCCS 参与者是严重 COVID-19 疾病的高危人群感染者，主要是老年人，并且有许多潜在的合并症。所以，为了他们的健康，他们必须接种新的 COVID-19 疫苗。迄今为止，然而，关于 COVID-19 疫苗在人群中的接受度和功效的轶事数据感染艾滋病毒（艾滋病毒感染者）。 MWCCS 非常适合分析 (a) COVID-19 的接受度和影响男性和女性感染者和匹配的未感染艾滋病毒对照 (HUC) 中的疫苗，(b) 影响年龄和合并症对疫苗免疫反应和针对 COVID-19 的保护的影响，以及 (c) 与之前相比，接种 COVID-19 疫苗后的社会、经济和行为变化选择不接种疫苗的人。为了解决这个问题，我们将有 2 个小组本研究中的 MWCCS 参与者人数：A 组：选择的男性和女性 PWH 和 HUC 接受 COVID-19 疫苗，B 组：选择不接种的男性和女性 PWH 和 HUC 接种 COVID-19 疫苗。我们为此提出的纵向观察研究的目的 OAR 创新应用是：目标 1：开展 MWCCS 范围内的混合方法对 COVID-19 疫苗犹豫的流行率、相关性和细微差别的调查 MWCCS 参与者中。结果将有助于更好地理解 PWH 和 HUC 的担忧基于年龄、性别、种族/民族和基础的关于 COVID-19 疫苗的人群共同负担。目标 2：确定自然 SARS-CoV-2 感染后的发生率与相同年龄、性别和民族/种族的 HUC 相比，PWH 中的 COVID-19 免疫接种情况并与未接种疫苗的个体的感染发生率进行比较。由于由于 OAR 创新基金补充中的预算限制，我们将目标 2 限制为获得基线时的一个样本，A 组之前接种疫苗，且在可比较的时间内 B 组的周期。将使用在 MWCCS 核心访问期间收集的后续样本在血清学分析中。这些样本将使我们能够确定 COVID-19 的血清学 S 和 N 蛋白的免疫前状态和免疫后血清转化。这免疫后抗 S 反应的滴定将表明疫苗免疫反应，而抗 S N 抗体滴度将表明自然 SARS-CoV-2 感染该信息将允许识别感染 SARS-CoV-2 后的无症状和有症状个体接种疫苗组和未接种疫苗组。如果 MWCCS 中的这些感染将允许定向利用核心样本深入研究疫苗免疫机制介导的保护、突破的免疫反应和病毒学特征 SARS-CoV-2 感染，以及疫苗接种对潜在 HIV 感染的影响。重要的是，从 OAR 创新机会中及时获得资金对于我们至关重要在我们的感染者卫生院广泛推广 COVID-19 疫苗之前实现这些目标参与者。我们正在竞相在我们的 MWCCS 参与者可以广泛获得当前 FDA EUA 疫苗。 MWCC 美国各地的临床研究中心和数据中心已准备好推出这一新产品一旦资金到位并且我们获得 SRB 批准，我们就会立即进行研究。