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

Immune response and safety to inactivated COVID-19 vaccine: a comparison between people living with HIV and HIV-naive individuals.
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DOI:
10.1186/s12981-022-00459-y
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发表时间:
2022-07-05
影响因子:
2.2
通讯作者:
--
中科院分区:
医学3区
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--
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多种类型的COVID-19疫苗已在成人中显示出对抗COVID-19的安全性和有效性。尽管目前的指南鼓励艾滋病毒感染者(PLWH)接种COVID-19疫苗,但他们对COVID-19疫苗的免疫反应是否与无艾滋病毒的个体不同仍不清楚。2021年3月至6月,48名PLWH和40名HNC(年龄18至59岁)入组了武汉市武昌区的研究。所有受试者均在第0天接种了灭活COVID-19疫苗(国药控股,WIBP-CorV,武汉生物制品研究所有限公司),并在第28天接种了第二剂。主要安全性结局为每次注射后7天内的合并不良反应。主要免疫原性结果是在基线(第0天)、第14天、第28天、第42天和第70天通过化学发光检测的SARS-CoV-2中和抗体(nAbs)应答以及通过ELISA和胶体金检测的总特异性IgM和IgG抗体应答。该研究共包括46名PLWH和38名HNC,他们完成了70天的随访。PLWH(30%和11%)与HNC(32%和24%)之间第一次和第二次给药的不良反应频率没有差异。在PLWH中NAbs反应在第70天达到峰值,而在HNC中在第42天达到峰值。在第42天,PLWH中nAb的几何平均浓度(GMC)和血清转换率为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),血清阳转率(63%,95%CI 44-79)]。PLWH和HNC中的IgG应答在第70天达到峰值。在第70天,PLWH中IgG的几何平均ELISA单位(GMEU)和血清转换率为0.193 ELISA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),血清转换率(86%,95% CI 64-97)]。未发生严重不良事件。与HNC相比,PLWH人群对灭活COVID-19疫苗的早期体液免疫应答较弱且延迟。无论有效抗逆转录病毒治疗的高CD 4计数如何,该观察结果保持一致。在线版本包含补充材料,可通过10.1186/s12981-022-00459-y获得。
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. 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. 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. 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. The online version contains supplementary material available at 10.1186/s12981-022-00459-y.
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