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免疫应答和安全性:感染 HIV 人群与 HIV 阴性人群接种新冠灭活疫苗的比较

Immune response and safety to inactivated COVID-19 vaccine: a comparison between people living with HIV and HIV-naive individuals.

机构信息

Department of Infectious Diseases, Zhongnan Hospital of Wuhan University, Wuhan, China.

Wuchang District Center for Disease Control and Prevention, Wuhan, China.

出版信息

AIDS Res Ther. 2022 Jul 5;19(1):33. doi: 10.1186/s12981-022-00459-y.

Abstract

BACKGROUND

Multi-types COVID-19 vaccines have shown safety and efficacy against COVID-19 in adults. Although current guidelines encourage people living with HIV (PLWH) to take COVID-19 vaccines, whether their immune response to COVID-19 vaccines is distinct from HIV-free individuals is still unclear.

METHODS

Between March to June 2021, 48 PLWH and 40 HNC, aged 18 to 59 years, were enrolled in the study in Wuchang district of Wuhan city. All of them received inactivated COVID-19 vaccine (Sinopharm, WIBP-CorV, Wuhan Institute of Biological Products Co. Ltd) at day 0 and the second dose at day 28. The primary safety outcome was the combined adverse reactions within 7 days after each injection. The primary immunogenicity outcomes were SARS-CoV-2 neutralizing antibodies (nAbs) responses by chemiluminescence and total specific IgM and IgG antibodies responses by ELISA and colloidal gold at baseline (day 0), day 14, day 28, day 42, and day 70.

RESULTS

In total, the study included 46 PLWH and 38 HNC who finished 70 days' follow-up. The frequency of adverse reactions to the first and second dose was not different between PLWH (30% and 11%) vs. HNC (32% and 24%). NAbs responses among PLWH peaked at day 70, while among HNC peaked at day 42. At day 42, the geometric mean concentration (GMC) and seroconversion rate of nAbs among PLWH were 4.46 binding antibody units (BAU)/mL (95% CI 3.18-5.87) and 26% (95% CI 14-41), which were lower than that among HNC [GMC (18.28 BAU/mL, 95% CI 10.33-32.33), seroconversion rate (63%, 95% CI 44-79)]. IgG responses among both PLWH and HNC peaked at day 70. At day 70, the geometric mean ELISA units (GMEU) and seroconversion rate of IgG among PLWH were 0.193 ELISA units (EU)/mL (95% CI 0.119-0.313) and 51% (95% CI 34-69), which was lower than that among HNC [GMEU (0.379 EU/mL, 95% CI 0.224-0.653), seroconversion rate (86%, 95% CI 64-97)]. There were no serious adverse events.

CONCLUSIONS

Early humoral immune response to the inactivated COVID-19 vaccine was weaker and delayed among the PLWH population than that among HNC. This observation remained consistent regardless of a high CD4 count with effective antiretroviral therapy.

摘要

背景

多种类型的 COVID-19 疫苗已在成年人中显示出对 COVID-19 的安全性和有效性。尽管目前的指南鼓励 HIV 感染者(PLWH)接种 COVID-19 疫苗,但他们对 COVID-19 疫苗的免疫反应是否与无 HIV 个体不同仍不清楚。

方法

2021 年 3 月至 6 月期间,在武汉市武昌区招募了 48 名 PLWH 和 40 名 HNC(年龄在 18 至 59 岁之间)。他们均于第 0 天和第 28 天接受了灭活的 COVID-19 疫苗(国药中生,WIBP-CorV,武汉生物制品研究所)。主要安全性结局是每次注射后 7 天内的联合不良反应。主要免疫原性结局是通过化学发光测定 SARS-CoV-2 中和抗体(nAbs)反应,通过 ELISA 和胶体金测定总特异性 IgM 和 IgG 抗体反应,基线(第 0 天)、第 14 天、第 28 天、第 42 天和第 70 天。

结果

总共有 46 名 PLWH 和 38 名 HNC 完成了 70 天的随访。PLWH(分别为 30%和 11%)和 HNC(分别为 32%和 24%)第一剂和第二剂的不良反应频率无差异。PLWH 的 nAbs 反应在第 70 天达到峰值,而 HNC 的 nAbs 反应在第 42 天达到峰值。在第 42 天,PLWH 的 nAbs 的几何平均浓度(GMC)和血清转化率为 4.46 结合抗体单位(BAU)/mL(95%CI 3.18-5.87)和 26%(95%CI 14-41),低于 HNC [GMC(18.28 BAU/mL,95%CI 10.33-32.33),血清转化率(63%,95%CI 44-79%)]。PLWH 和 HNC 的 IgG 反应均在第 70 天达到峰值。在第 70 天,PLWH 的 IgG 的酶联免疫吸附测定单位(GMEU)和血清转化率为 0.193 酶联免疫吸附测定单位(EU)/mL(95%CI 0.119-0.313)和 51%(95%CI 34-69),低于 HNC [GMEU(0.379 EU/mL,95%CI 0.224-0.653),血清转化率(86%,95%CI 64-97%)]。没有严重不良事件。

结论

与 HNC 相比,PLWH 人群对灭活 COVID-19 疫苗的早期体液免疫反应较弱且延迟。这种观察结果在 CD4 计数高且抗逆转录病毒治疗有效的情况下仍然一致。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c5cc/9254537/8e7069846436/12981_2022_459_Fig1_HTML.jpg

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