Clinic of Infectious Diseases, University of Bari, Bari, Italy.
Department of Biomedical Science, Human Oncology-Hygiene Section, University of Bari, Bari, Italy.
J Med Virol. 2022 May;94(5):2230-2236. doi: 10.1002/jmv.27629. Epub 2022 Feb 8.
In March, people living with HIV infection (PLWH) were included in the risk category of fragile people for severe COVID-19 receiving priority access to vaccination with BNT162b2 vaccine. The aim of the study was to evaluate the immunogenicity and safety of the two doses regimen. The antibodies titer for severe acute respiratory syndrome-related coronavirus-2 (SARS-CoV-2) was evaluated after 21 days since the first administration (Time 1), 1 (Time 2), and 3 (Time 3) months post-vaccination. Information regarding virological and immunological conditions at baseline, previous SARS-CoV-2 state of infection, other immunodeficiencies, current antiretroviral therapy (ART), comorbidities, and severe adverse events (SAE) to vaccination was collected. Six hundred and ninety-seven patients were tested for quantitative anti-spike antibodies at Time 1, 577 patients had a second detection at Time 2, and 491 patients had the third detection. Baseline characteristics of the study population are reported in Table 1. At the time of vaccine administration, all patients were on ART (except one long-term nonprogressor); 632 (90.7%) patients had undetectable HIV-RNA; 12 (1.7%) patients were immunosuppressed due to chemotherapy or other immunosuppressive drugs; 345 (49.5%) patients had at least one COVID-19 related comorbidity and 155 (22.2%) had two or more comorbidities. No SAEs were reported. Final serological results are available for 694 patients after the first dose, 577 and 491 after the second and third ones, respectively; positive titer (values ≥ 50 AU/ml) was demonstrated in 653 (94.1%), 576 (99.8%), 484 (98.6%) patients, respectively. Only one patient was a nonresponder after completing vaccination, who was a newly diagnosed one for HIV infection. All vaccinations were well tolerated, with no SAEs. BNT162b2 mRNA vaccine was immunogenic and safe in PLWH.
在三月份，感染 HIV 的人群（PLWH）被纳入 COVID-19 重症高风险脆弱人群，优先接种 BNT162b2 疫苗。本研究旨在评估两剂方案的免疫原性和安全性。在接种第一剂后 21 天（时间点 1）、1 个月（时间点 2）和 3 个月（时间点 3），评估针对严重急性呼吸综合征相关冠状病毒-2（SARS-CoV-2）的抗体滴度。收集了基线时的病毒学和免疫学状况、既往 SARS-CoV-2 感染状态、其他免疫缺陷、当前抗逆转录病毒治疗（ART）、合并症和接种疫苗后的严重不良事件（SAE）信息。697 例患者在时间点 1 时进行了定量抗刺突抗体检测，577 例患者在时间点 2 时进行了第二次检测，491 例患者在时间点 3 时进行了第三次检测。表 1 报告了研究人群的基线特征。在接种疫苗时，所有患者均接受 ART（除了一名长期非进展者）；632 例（90.7%）患者的 HIV-RNA 不可检测；12 例（1.7%）患者因化疗或其他免疫抑制药物而免疫抑制；345 例（49.5%）患者至少有一种 COVID-19 相关合并症，155 例（22.2%）有两种或更多种合并症。未报告 SAE。第一次接种后，694 例患者的最终血清学结果可用，第二次和第三次接种后，577 例和 491 例患者的结果可用；分别有 653 例（94.1%）、576 例（99.8%）、484 例（98.6%）患者的抗体滴度阳性（值≥50 AU/ml）。仅有 1 例患者在完成接种后未应答，该患者新诊断为 HIV 感染。所有疫苗接种均耐受良好，无 SAE。BNT162b2 mRNA 疫苗在 PLWH 中具有免疫原性和安全性。
