Objectives

The immunogenicity and safety of the Pfizer-BioNTech BNT162b2 mRNA vaccine in people living with human immunodeficiency virus type 1 (PLWH) are unknown. We aimed to assess the immunogenicity and safety of this vaccine in PLWH.

Methods

In this prospective open study, we enrolled 143 PLWH, aged ≥18 years, who attended our clinic and 261 immunocompetent health-care workers (HCWs). Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) receptor binding domain (RBD) IgG and neutralizing antibodies were measured. Adverse events, viral load and CD4 cell counts were monitored.

Results

At a median of 18 days (interquartile range 14–21 days) after the second dose, anti-RBD-IgG was positive in 139/141 (98%) PLWH. Among HCWs, 258/261 (98.9%) developed anti-RBD-IgG at a median of 26 days (interquartile range 24–27 days) after the second dose. Following the second dose, immune sera neutralized SARS-CoV-2 pseudo-virus in 97% and 98% of PLWH and HCWs, respectively. Adverse events were reported in 60% of PLWH, mainly pain at the injection site, fatigue and headache. AIDS-related adverse events were not reported. Human immunodeficiency virus load increased in 3/143 (2%) patients from <40 copies/mL to ≤100 copies/mL. CD4⁺ T-cell count decreased from a geometric mean of 700 cells/μL (95% CI 648–757 cells/μL) to 633.8 cells/μL (95% CI 588–683 cells/μL) (p < 0.01).

Conclusions

BNT162b2 mRNA vaccine appears immunogenic and safe in PLWH who are on antiretroviral therapy with unsuppressed CD4 count and suppressed viral load.

中文翻译：

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BNT162b2 mRNA COVID-19 疫苗对 HIV-1 感染者的免疫原性和安全性

目标

Pfizer-BioNTech BNT162b2 mRNA 疫苗对 1 型人类免疫缺陷病毒 (PLWH) 患者的免疫原性和安全性尚不清楚。我们旨在评估该疫苗在 PLWH 中的免疫原性和安全性。

方法

在这项前瞻性开放研究中，我们招募了 143 名年龄 ≥ 18 岁、就诊于我们诊所的 PLWH 和 261 名具有免疫能力的卫生保健工作者 (HCW)。测量了严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 受体结合域 (RBD) IgG 和中和抗体。监测不良事件、病毒载量和 CD4 细胞计数。

结果

在第二次给药后平均 18 天（四分位距为 14-21 天）时，139/141 (98%) PLWH 的抗 RBD-IgG 呈阳性。在医护人员中，258/261 (98.9%) 在第二次给药后的中位时间为 26 天（四分位距为 24-27 天）产生了抗 RBD-IgG。在第二次给药后，免疫血清分别中和了 97% 和 98% 的 PLWH 和 HCW 中的 SARS-CoV-2 假病毒。60% 的 PLWH 报告了不良事件，主要是注射部位疼痛、疲劳和头痛。未报告与艾滋病相关的不良事件。3/143 (2%) 患者的人类免疫缺陷病毒载量从 <40 拷贝/mL 增加到≤100 拷贝/mL。CD4 ⁺ T 细胞计数从几何平均值 700 个细胞/μL（95% CI 648–757 个细胞/μL）降至 633.8 个细胞/μL（95% CI 588–683 个细胞/μL）（p < 0.01）。

结论

BNT162b2 mRNA 疫苗在接受抗逆转录病毒治疗且 CD4 计数未受抑制和病毒载量受抑制的 PLWH 中具有免疫原性和安全性。