COVID-19 Vaccination among People Living with HIV: Immunogenicity, Effectiveness, and Safety [COVAXHIV, study data contributed to the CITF Databank]

<b>Background:</b> COVID-19 may pose a greater risk for people living with HIV (PLWH) who already face multiple vulnerabilities and more often belong to groups disproportionately affected by the pandemic. Vaccines that prevent COVID-19 can provide critical benefits for this priority vaccination group. However, people living with HIV have been understudied in COVID-19 vaccine clinical trials. <br>

<b>Objectives of the CITF-funded study:</b> The first aim of the funded study, from which data for the PLWH cohort was shared, was to compare the immunogenicity of COVID-19 vaccines among PLWH compared to people who are HIV-negative, particularly regarding the necessity for additional doses. <br>

<b>Methods:</b> COVAXHIV used a cohort design with the treated group followed from second dose of SARS-CoV-2 vaccination. Outcome measures included SARS-CoV-2 serology and neutralization capacity[, and hospitalization due to COVID-19] up to 12 months post third dose. PLWH 16 years and older were recruited from clinics in Montreal, Ottawa, Toronto, and Vancouver, Canada, and through social media. Enrollment was between April 2021 and January 2022. Participants were excluded if they had an active COVID infection or three doses prior to enrollment. (HIV negative participants 18 years and older were recruited through an existing research project, Stop the Spread Ottawa, and are not in the contributed data.) Data were collected through a standardized questionnaire capturing health behaviors, medical history, and serological samples to evaluate COVID-19-specific antibodies, with a focus on post-third and fourth vaccine doses. <br>

<b>Contributed dataset contents:</b> The contributed data included 375 participants living with HIV who completed baseline visits between January 2021 and May 2022 (344 participants with follow-up). A total of 4,548 serum and plasma from 99 participants were collected for SARS-CoV-2 serology, ACE2 displacement and live virus neutralization between November 2020 and October 2022. Cellular immunity test results for 169 blood samples from 50 participants are stored with the Romney T-cell mediated immunity dataset, linked by participant ID. <br>

Variables include data in the following areas of information: demographics (age, sex and gender, race and indigeneity), general health (tobacco use, chronic conditions, height and weight, flu vaccine), exposure risk factors (travel, occupation, gathering, compliance to COVID-19 preventive behaviors), longitudinal follow-up for COVID infections (COVID tests, symptoms, hospitalization), COVID vaccination history (number of vaccine doses, vaccination during pregnancy) and serology (ACE2 displacement, serology and live virus neutralization).

**背景：** 新型冠状病毒肺炎（COVID-19）对人类免疫缺陷病毒感染者（People Living With HIV, PLWH）的威胁更为严峻——这一群体本已面临多重健康脆弱性，且更常属于新冠疫情中受影响不成比例的高危群体。能够预防新冠的疫苗可为这一优先接种群体带来关键获益。然而，新冠疫苗临床试验中针对PLWH的研究始终不足。

**CITF资助研究的目标：** 本次共享PLWH队列数据的CITF资助研究，其首要目标为对比新冠疫苗在人类免疫缺陷病毒感染者与HIV阴性人群中的免疫原性，尤其关注加强针接种的必要性。

**研究方法：** COVAXHIV研究采用队列研究设计，对疫苗接种队列人群从第二剂严重急性呼吸综合征冠状病毒2型（SARS-CoV-2）疫苗接种后启动随访。结局指标包括第三剂疫苗接种后12个月内的SARS-CoV-2血清学检测结果、中和活性[以及新冠相关住院情况]。研究招募了加拿大蒙特利尔、渥太华、多伦多、温哥华各临床机构以及社交媒体渠道的16岁及以上人类免疫缺陷病毒感染者，招募时间为2021年4月至2022年1月。排除标准为入组前已发生活动性新冠感染或已完成3剂疫苗接种的受试者。（18岁及以上的HIV阴性受试者通过现有研究项目《Stop the Spread Ottawa》招募，未纳入本次共享数据集。）研究通过标准化问卷收集受试者健康行为、病史等信息，并采集血清学样本以评估新冠特异性抗体，重点关注第三剂及第四剂疫苗接种后的相关指标。

**共享数据集内容：** 本次共享的数据涵盖375名于2021年1月至2022年5月间完成基线访视的人类免疫缺陷病毒感染者，其中344名完成了随访。研究于2020年11月至2022年10月期间，从99名受试者中采集了总计4548份血清及血浆样本，用于SARS-CoV-2血清学检测、血管紧张素转换酶2（ACE2）置换检测以及活病毒中和试验。另有来自50名受试者的169份血液样本的细胞免疫检测结果，已通过受试者唯一标识ID关联并存储于Romney T细胞介导免疫数据集（Romney T-cell mediated immunity dataset）。

**数据集变量说明：** 数据集包含以下类别的信息：人口统计学资料（年龄、生理性别与社会性别、种族与原住民身份）、一般健康状况（烟草使用情况、慢性疾病史、身高体重、流感疫苗接种史）、暴露风险因素（旅行史、职业暴露、聚集性活动、新冠防疫行为依从性）、新冠感染纵向随访数据（新冠检测结果、症状、住院情况）、新冠疫苗接种史（疫苗总剂次、妊娠期接种情况）以及血清学检测指标（ACE2置换检测、血清学检测及活病毒中和试验）。