Clinical Research Sites for the MACS/WIHS Combined Cohort Study (MACS/WIHS-CCS)

MACS/WIHS 联合队列研究 (MACS/WIHS-CCS) 的临床研究中心

• 批准号: 10401178
• 负责人: Kathryn M. Anastos
• 金额: $ 4.04万
• 依托单位: ALBERT EINSTEIN COLLEGE 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/10401178
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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 Scientific Justification A safe, highly immunogenic vaccine to prevent primary SARS-CoV-2 infection is needed to control the COVID-19 pandemic. As of January, 2021, the United States is racing to vaccinate a significant percentage of our 330 million population to control the COVID-19 pandemic. This extraordinary rapid development resulted from FDA emergency use authorization (EUA) of two COVID-19 vaccines in December, 2020, i.e., the Moderna mRNA-1273 vaccine that codes for the stabilized pre-fusion SARS- CoV-2 spike protein 1, and the Pfizer/BioNTech vaccine BNT162b1 that is a lipid-nanoparticle-formulated, nucleoside-modified mRNA vaccine that encodes the trimerized receptor-binding domain of the spike glycoprotein of SARS-CoV-2 2. Despite this enormous public health issue of stopping the COVID-19 pandemic, there are essentially no data on COVID-9 vaccine acceptance or efficacy in people with HIV (PWH). This is critically important for public health, in that an estimated 1.2 million people aged 13 and older have HIV in the United States, including an estimated 161,800 (14%) people whose infections had not been diagnosed 3. Although several COVID-19 vaccine clinical efficacy trials enrolled PWH without specific selectivity, there are insufficient data exist to determine the efficacy of COVID-19 vaccines in PWH. Indeed, prior to the COVID-19 pandemic, the CDC recommended that PWH with CD4 T cell counts of ≥200 or percentages ≥15% receive all licensed vaccines. Further, the CDC stated in a release December 12, 2020 (https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-12/slides-12-12/COVID-03- Mbaeyi.pdf): “The recently FDA-authorized Pfizer-BioNTech COVID-19 vaccine is not contraindicated for people living with HIV or others with immunocompromised conditions, though vaccine efficacy data does not currently exist for potentially immunocompromised individuals”. According to the CDC Advisory Committee on Immunization Practices (ACIP), “people living with HIV may still receive the vaccine, but should be counseled on unknown vaccine safety and efficacy profiles in immunocompromised persons.” The ACIP also recently recommended that health care personnel and residents of long-term care facilities (LTCFs) be offered vaccination in the initial phase of the COVID-19 vaccination program (Phase 1a) 4. In sum, PWH are looking to us for advice as their scientific and clinical HIV experts, with our response being that the COVID-19 vaccines “should be” safe and effective in them based on no specific data. Our proposed study aims to supply such data through a well-designed protocol nested in the most well-established and trusted MACS-WIHS Combined Cohort Study (MWCCS).

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 科学依据 需要一种安全、高免疫原性的疫苗来预防原发性SARS-CoV-2感染，以控制 2019冠状病毒病大流行。截至2021年1月，美国正在竞相接种疫苗， 占我们3.3亿人口的20%，以控制COVID-19疫情。这一惊人的速度 FDA紧急使用授权（EUA）导致两种COVID-19疫苗的开发， 2020年12月，即，编码稳定的融合前SARS的Moderna mRNA-1273疫苗- CoV-2刺突蛋白1和Pfizer/BioNTech疫苗BNT 162 b1，后者是一种脂质纳米颗粒制剂， 编码刺突的三聚化受体结合结构域的核苷修饰的mRNA疫苗 2. SARS-CoV-2糖蛋白 尽管有阻止COVID-19大流行的巨大公共卫生问题，但基本上没有 关于COVID-9疫苗在艾滋病毒感染者中的接受程度或有效性的数据。这是至关重要的 在公共卫生方面，美国估计有120万13岁及以上的人感染艾滋病毒， 包括估计161，800人（14%）未被诊断出感染3。虽然 几项COVID-19疫苗临床有效性试验在没有特定选择性的情况下招募了PWH， 没有足够的数据来确定2019冠状病毒病疫苗在威尔斯亲王医院的疗效。事实上， COVID-19大流行，CDC建议CD 4 T细胞计数≥200或百分比的PWH ≥15%的人接种了所有许可的疫苗。此外，CDC在2020年12月12日的一份声明中表示， （网址：http：//www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-12/slides-12-12/COVID-03- Mbaeyi.pdf）：“最近FDA授权的辉瑞-BioNTech COVID-19疫苗不禁忌用于 艾滋病毒感染者或其他免疫功能低下的人，尽管疫苗有效性数据 目前还不存在潜在的免疫功能低下的个人”。根据cdc 免疫实践咨询委员会（ACIP），“艾滋病毒感染者仍然可以接受 疫苗，但应咨询未知的疫苗安全性和有效性概况， 免疫力低下的人”ACIP最近还建议卫生保健人员和 在COVID-19的初始阶段为长期护理设施（LTCF）的居民提供疫苗接种 疫苗接种计划（第1a阶段）4.总括而言，威尔斯亲王医院正寻求我们的意见， 我们的回应是，COVID-19疫苗“应该”是安全的， 在没有具体数据的情况下有效。我们拟议的研究旨在通过以下途径提供这些数据： 一个精心设计的协议嵌套在最完善和最值得信赖的MACS-WIHS组合 队列研究（MWCCS）。