Feng Yanmeng, Zhang Yifan, He Zhangyufan, Huang Haojie, Tian Xiangxiang, Wang Gang, Chen Daihong, Ren Yanqin, Jia Liqiu, Wang Wanhai, Wu Jing, Shao Lingyun, Zhang Wenhong, Tang Heng, Wan Yanmin
Hubei Provincial Center for Disease Control and Prevention, Wuhan 430065, China.
Department of Infectious Disease of Huashan Hospital, National Medical Center for Infectious Diseases and Shanghai Key Laboratory of Infectious Diseases and Biosafety Emergency Response, Fudan University, Shanghai 200040, China.
EClinicalMedicine. 2022 Jan;43:101226. doi: 10.1016/j.eclinm.2021.101226. Epub 2021 Dec 4.
Inactivated COVID-19 vaccines are safe and effective in the general population with intact immunity. However, their safety and immunogenicity have not been demonstrated in people living with HIV (PLWH).
42 HIV-1 infected individuals who were stable on combination antiretroviral therapy (cART) and 28 healthy individuals were enrolled in this open-label two-arm non-randomized study at Hubei Provincial Center for Disease Control and Prevention, China. Two doses of an inactivated COVID-19 vaccine (BBIBP-CorV) were given on April 22, 2021 and May 25, 2021, respectively. The reactogenicity of the vaccine were evaluated by observing clinical adverse events and solicited local and systemic reactions. Humoral responses were measured by anti-spike IgG ELISA and surrogate neutralization assays. Cell-mediated immune responses and vaccine induced T cell activation were measured by flow cytometry.
All the HIV-1 infected participants had a CD4 T cell count >200 cells/μL both at baseline (659·0 ± 221·9 cells/μL) and 4 weeks after vaccination (476·9 ± 150·8 cells/μL). No solicited adverse reaction was observed among all participants. Similar binding antibody, neutralizing antibody and S protein specific T cell responses were elicited in PLWH and healthy individuals. PLWH with low baseline CD4/CD8 T cell ratios (<0·6) generated lower antibody responses after vaccination than PLWH with medium (0·6∼1·0) or high (≥1·0) baseline CD4/CD8 T cell ratios (P<0·01). The CD3, CD4 and CD8 T cell counts of PLWH decreased significantly after vaccination (P<0·0001), but it did not lead to any adverse clinical manifestation. Moreover, we found that the general HIV-1 viral load among the PLWH cohort decreased significantly after vaccination (P=0·0192). The alteration of HIV-1 viral load was not significantly associated with the vaccine induced CD4 T cell activation (P>0·2).
Our data demonstrated that the inactivated SARS-CoV-2 vaccine was safe, immunogenic in PLWH who are stable on cART with suppressed viral load and CD4 T cell count > 200 cells/μL. However, the persistence of the vaccine-induced immunities in PLWH need to be further investigated.
灭活新冠疫苗在免疫功能正常的普通人群中安全有效。然而，其在艾滋病病毒感染者（PLWH）中的安全性和免疫原性尚未得到证实。
42例接受联合抗逆转录病毒治疗（cART）病情稳定的HIV-1感染者和28例健康个体在中国湖北省疾病预防控制中心参与了这项开放标签双臂非随机研究。分别于2021年4月22日和2021年5月25日接种两剂灭活新冠疫苗（BBIBP-CorV）。通过观察临床不良事件以及询问局部和全身反应来评估疫苗的反应原性。通过抗刺突IgG ELISA和替代中和试验检测体液免疫反应。通过流式细胞术检测细胞介导的免疫反应和疫苗诱导的T细胞活化。
所有HIV-1感染参与者在基线时（659.0±221.9个细胞/μL）和接种疫苗4周后（476.9±150.8个细胞/μL）的CD4 T细胞计数均>200个细胞/μL。所有参与者均未观察到询问到的不良反应。PLWH和健康个体产生了相似的结合抗体、中和抗体和S蛋白特异性T细胞反应。基线CD4/CD8 T细胞比率低（<0.6）的PLWH接种疫苗后产生的抗体反应低于基线CD4/CD8 T细胞比率中等（0.6∼1.0）或高（≥1.0）的PLWH（P<0.01）。PLWH接种疫苗后CD3、CD4和CD8 T细胞计数显著下降（P<0.0001），但未导致任何不良临床表现。此外，我们发现PLWH队列中的总体HIV-1病毒载量在接种疫苗后显著下降（P=0.0192）。HIV-1病毒载量的变化与疫苗诱导的CD4 T细胞活化无显著相关性（P>0.2）。
我们的数据表明，灭活SARS-CoV-2疫苗在接受cART治疗病情稳定、病毒载量得到抑制且CD4 T细胞计数>200个细胞/μL的PLWH中是安全且具有免疫原性的。然而，PLWH中疫苗诱导免疫的持久性需要进一步研究。
