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 MWCC参与者是严重Covid-19的高风险组，就HIV-而言被感染，主要由老年时代，并且具有许多潜在的合并症。所以，他们的健康必须接受新的Covid-19疫苗接种疫苗。迄今为止，但是，只有有关Covid-19的疫苗接受和疗效的轶事数据与艾滋病毒（PWH）。 MWCC非常适合分析（a）COVID-19的接受度和影响男性和雌性PWH的疫苗以及匹配的HIV未感染对照（HUC），（b）撞击疫苗免疫反应和针对Covid-19的年龄和合并症，以及（c）相比选择不接受疫苗的人。为了解决这个问题，我们将有2个小组本研究的MWCC参与者：A组：选择的男性和女性PWH和HUC 要接收Covid-19疫苗，B组B组：男性和女性PWH和HUC，他们选择不接收Covid-19疫苗。我们提议的纵向观察研究的目的 OAR创新应用是：目标1：进行MWCCS范围范围的混合方法研究Covid-19疫苗犹豫的患病率，相关性和细微差别在MWCC参与者中。结果将有助于更好地了解PWH和HUC的关注点基于年龄，性别，种族/种族和基础的Covid-19疫苗的人群 Comormity负担。目标2：确定自然SARS-COV-2感染的发生率与同龄年龄，性别和种族/种族的HUC相比还与未接种疫苗的个体感染的发生率相比。由于 OAR创新基金补充中的预算限制，我们将限制AIM 2获得一个基线时的一个标本，仅在A组中的事先疫苗接种，并且在可比的时间内 B组B组的期间将使用核心MWCC访问期间收集的样本在血清学分析中。这些样品将使我们能够确定血清学互联-19 状态前免疫和S和N蛋白的免疫后血清转化。这免疫后抗S反应的滴定将表明疫苗免疫反应，而抗 n抗体滴度将表明天然SARS-COV-2感染此信息将允许鉴定无症状和有症状的个体感染了SARS- COV-2 疫苗接种和非疫苗接种组。如果MWCC中的这些感染将允许有针对性地使用核心样品在深入研究疫苗的免疫机制中介导的保护，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的HIV感染的影响。重要的是，从这个桨创新机会中及时资助对我们来说至关重要在将COVID-19疫苗推出到我们的PWH之前，请解决这些目标参与者。我们正在竞赛，以获取这些关键信息和标本当前的FDA EUA疫苗广泛可用于我们的MWCC参与者。 MWCCS 美国和数据中心的临床研究网站准备启动这个新的一旦获得资金，我们就会获得SIRB批准。