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).

COVID疫苗研究补充：MWCCS主要研究人员：C.Rinaldo和J.Martinson 创新基金应用于多中心艾滋病队列研究(MACS)/妇女 机构间艾滋病毒研究(WIHS)联合队列研究：新冠肺炎疫苗接受度 艾滋病毒携带者的犹豫不决(CVHB)研究 科学论证 需要一种安全的、高免疫原性的疫苗来预防原发SARS-CoV-2感染，以控制 新冠肺炎大流行。截至2021年1月，美国正在竞相接种一种重要的 占我们3.3亿人口的比例，以控制新冠肺炎疫情。这一惊人的速度 年FDA对两种新冠肺炎疫苗的紧急使用授权(EUA)导致的开发 2020年12月，即编码稳定的融合前SARS的现代mRNA-1273疫苗- CoV-2 Spike Protein 1，以及辉瑞/BioNTech疫苗BNT162b1，这是一种脂质纳米颗粒配方， 编码刺激区三聚化受体结合域的核苷修饰的信使核糖核酸疫苗 SARS-CoV-2糖蛋白 尽管存在阻止新冠肺炎大流行的巨大公共卫生问题，但基本上没有 关于艾滋病病毒感染者(PWH)对COVID-9疫苗接受度或有效性的数据。这一点至关重要。 在公共卫生方面，据估计，美国13岁及以上的人中有120万人感染艾滋病毒， 包括估计有161,800人(14%)的感染未被诊断3。 几项新冠肺炎疫苗临床疗效试验在没有特定选择性的情况下纳入了PWH，有 目前还没有足够的数据来确定新冠肺炎疫苗在威斯康星医院的疗效。事实上，在此之前 在新冠肺炎大流行期间，疾控中心建议威斯康星患者的CD4T细胞计数为≥200或百分数 15%的≥接种所有获得许可的疫苗。此外，疾控中心在2020年12月12日的一份新闻稿中表示 (https://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-生物技术新冠肺炎疫苗没有禁忌 艾滋病毒携带者或其他免疫功能受损的人，尽管疫苗效力数据 目前还不适用于可能存在免疫功能受损的个人“。根据疾控中心的说法 免疫接种做法咨询委员会(ACIP)表示：“艾滋病毒携带者仍有可能获得 疫苗，但应就未知的疫苗安全性和有效性在 免疫功能受损的人。“ACIP最近还建议卫生保健人员和 在新冠肺炎初期为长期护理设施居民提供疫苗接种 疫苗接种计划(1a期)4.总括而言，威尔斯亲王医院正寻求我们的意见，因为他们的科学和 临床艾滋病毒专家，我们的反应是，新冠肺炎疫苗应该是安全和 在没有具体数据的情况下对它们有效。我们建议的研究旨在通过以下方式提供这些数据 设计良好的协议嵌套在最成熟和最受信任的Mac-WIHS组合中 队列研究(MWCCS)。