Lombardi Andrea, Butta Giacomo M, Donnici Lorena, Bozzi Giorgio, Oggioni Massimo, Bono Patrizia, Matera Malvina, Consonni Dario, Ludovisi Serena, Muscatello Antonio, Ceriotti Ferruccio, Conti Matteo, Scaglioni Susanna, Gallo Greta, Scarpa Edoardo, Letko Michael, Abrignani Sergio, Grifantini Renata, De Francesco Raffaele, Gori Andrea, Manganaro Lara, Bandera Alessandra
Infectious Diseases Unit, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy.
Lancet Reg Health Eur. 2022 Feb;13:100287. doi: 10.1016/j.lanepe.2021.100287. Epub 2021 Dec 23.
Vaccines against COVID-19 are a powerful tool to control the current SARS-CoV-2 pandemic. A thorough description of their immunogenicity among people living with HIV (PLWHIV) is necessary. We aimed to assess the immunogenicity of the mRNA-1273 vaccine among PLWHIV.
In this prospective cohort, adult PLWHIV outpatients were enrolled during the Italian vaccination campaign. Enrolment was allowed irrespective of ongoing combination antiretroviral therapy (ART), plasma HIV viral load and CD4+ T cell count. A two-dose regimen of mRNA-1273, with administrations performed 28 days apart, was employed. The primary outcomes were anti-spike (anti-S) antibody titres and neutralising antibody activity, assessed 28 days after completing the vaccination schedule. A convenient sample of individuals not affected by HIV was also collected to serve as control (referred as healthy-donors, HDs).
We enrolled 71 PLWHIV, mostly male (84·5%), with a mean age of 47 years, a median CD4+ T cell count of 747·0 cells per µL and a median HIV viral load <50 copies/mL. COVID-19-experienced PLWHIV displayed higher anti-S antibody titres (p=0·0007) and neutralising antibody activity in sera (p=0·0007) than COVID-19-naïve PLWHIV. When stratified according to CD4+ T cell count (<350 cells/μL, 350-500 cells/μL, >500 cells/μL), anti-S antibody titres (6/71, median 2173 U/mL [IQR 987-4109]; 7/71, 5763 IU/mL [IQR 4801->12500]; 58/71, 2449 U/mL [IQR 1524-5704]) were not lower to those observed among HDs (10, median 1425 U/mL [IQR 599-6131]). In addition, neutralising antibody activity, stratified according to the CD4+ T cell count (6/71, median 1314 [IQR 606-2477]; 7/71, 3329 IU/mL [IQR 1905-10508]; 58/71, 1227 U/mL [IQR 761-3032]), was like those displayed by HDs (10, median 2112 U/mL [IQR 719-8889]).
In our cohort of PLWHIV with well-controlled ART, stable viral suppression and robust CD4+ T cell count, inoculation with mRNA-1273 vaccine given 4 weeks apart produced detectable humoral immune response, similar to individuals without HIV infection, supporting vaccination in PLWHIV.
This study was partially supported by Italian Ministry of Health Ricerca Corrente 2021, by Intesa San Paolo COVID-19 emergency 2020 funds, and by Fondazione Cariplo Grant (INNATE-CoV).
新型冠状病毒肺炎（COVID-19）疫苗是控制当前严重急性呼吸综合征冠状病毒2（SARS-CoV-2）大流行的有力工具。全面描述其在人类免疫缺陷病毒（HIV）感染者（PLWHIV）中的免疫原性很有必要。我们旨在评估mRNA-1273疫苗在PLWHIV中的免疫原性。
在这项前瞻性队列研究中，成年PLWHIV门诊患者在意大利疫苗接种活动期间入组。无论是否正在接受联合抗逆转录病毒治疗（ART）、血浆HIV病毒载量和CD4+T细胞计数如何，均允许入组。采用两剂mRNA-1273方案，间隔28天给药。主要结局是在完成疫苗接种计划28天后评估的抗刺突（anti-S）抗体滴度和中和抗体活性。还收集了一个未感染HIV个体的便利样本作为对照（称为健康供体，HDs）。
我们纳入了71例PLWHIV，大多数为男性（84.5%），平均年龄47岁，CD4+T细胞计数中位数为每微升747.0个细胞，HIV病毒载量中位数<50拷贝/毫升。有新型冠状病毒肺炎病史的PLWHIV比无新型冠状病毒肺炎病史的PLWHIV表现出更高的抗S抗体滴度（p=0.0007）和血清中和抗体活性（p=0.0007）。根据CD4+T细胞计数（<350个细胞/微升、350 - 500个细胞/微升、>500个细胞/微升）分层时，抗S抗体滴度（71例中的6例，中位数2173 U/mL[四分位间距987 - 4109]；71例中的7例，5763 IU/mL[四分位间距4801 ->12500]；71例中的58例，2449 U/mL[四分位间距1524 - 5704]）不低于HDs中观察到的滴度（10例，中位数1425 U/mL[四分位间距599 - 6131]）。此外，根据CD4+T细胞计数分层的中和抗体活性（71例中的6例，中位数1314[四分位间距606 - 2477]；71例中的7例，3329 IU/mL[四分位间距1905 - 10508]；71例中的58例，1227 U/mL[四分位间距761 - 3032]）与HDs表现出的活性相似（10例，中位数2112 U/mL[四分位间距719 - 8889]）。
在我们这个接受ART治疗控制良好、病毒抑制稳定且CD4+T细胞计数良好的PLWHIV队列中，间隔4周接种mRNA-1273疫苗产生了可检测到的体液免疫反应，与未感染HIV的个体相似，支持PLWHIV接种疫苗。
本研究部分得到了意大利卫生部2021年当前研究基金、联合圣保罗银行2020年COVID-19紧急基金以及卡里普洛基金会资助（INNATE-CoV）。
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