Rodríguez-Martinó Esteban, Medina-Prieto Rafael, Santana-Bagur Jorge, Santé María, Pantoja Petraleigh, Espino Ana M, Sariol Carlos A, Torres Esther A
MD. Division of Gastroenterology, Department of Medicine, University of Puerto Rico School of Medicine, San Juan, Puerto Rico.
Division of Infectious Diseases, Department of Medicine, University of Puerto Rico School of Medicine, San Juan.
medRxiv. 2021 Sep 15:2021.09.11.21263211. doi: 10.1101/2021.09.11.21263211.
Patients with immune conditions and immune-modifying therapies were excluded from the Covid-19 vaccine trials. Studies have shown conflicting response to different vaccines in persons receiving immune suppressors or biologics. The aim of this study is to evaluate humoral and cellular response to Covid-19 vaccines in patients with Inflammatory Bowel Disease (IBD) using biologic and/or immunomodulatory (IMM) therapies.
Participants are adults with IBD receiving biologics or IMM planning to receive a Covid 19 vaccine. Cellular immunity (CD4+ and CD8+ T cell levels) with flow cytometry are measured at baseline and 2 weeks after each vaccine dose. Humoral immunity (antibody titers and neutralizing capacity,VNT%) is analyzed by ELISA at baseline, 2 weeks after each dose, and 6 and 12 months after vaccine. We present the early results of the first 19 subjects. The study is approved by the IRB.
19 subjects (18 in biologics and 1 in IMM) who received 2 doses of the Pfizer-BioNTech vaccine are included. Total IgG antibodies increased 21.13 times after the first dose and 90 times after the second dose. VTN% increased 11.92 times after the first dose and 53.79 times after the second dose. When compared with a healthy control cohort, total IgG antibodies and VTN% were lower in the subjects after the first dose. After the second dose, IgG antibodies increased but remained lower than controls, but VTN% were similar to controls. CD4 and CD8 mean levels had an upward trend after vaccination.
Neutralizing capacity response to the vaccine in subjects was similar to a healthy cohort in spite of lower increases in total IgG antibodies. The CD4 and CD8 results observed may support the capacity to mount an effective cellular response in patients on biologics. Larger studies are needed to determine vaccine efficacy in these patients.
患有免疫疾病和接受免疫调节治疗的患者被排除在新冠疫苗试验之外。研究表明，接受免疫抑制剂或生物制剂治疗的人群对不同疫苗的反应存在差异。本研究的目的是评估使用生物制剂和/或免疫调节（IMM）疗法的炎症性肠病（IBD）患者对新冠疫苗的体液和细胞免疫反应。
参与者为患有IBD且正在接受生物制剂或IMM治疗并计划接种新冠疫苗的成年人。在每次接种疫苗的基线期和接种后2周，通过流式细胞术测量细胞免疫（CD4+和CD8+T细胞水平）。通过酶联免疫吸附测定法（ELISA）在基线期、每次接种后2周以及接种后6个月和12个月分析体液免疫（抗体滴度和中和能力，VNT%）。我们展示了前19名受试者的早期结果。该研究已获得机构审查委员会（IRB）的批准。
纳入了19名接受2剂辉瑞 - 生物科技疫苗的受试者（18名接受生物制剂治疗，1名接受IMM治疗）。首次接种后总IgG抗体增加了21.13倍，第二次接种后增加了90倍。首次接种后VTN%增加了11.92倍，第二次接种后增加了53.79倍。与健康对照队列相比，首次接种后受试者的总IgG抗体和VTN%较低。第二次接种后，IgG抗体增加但仍低于对照组，但VTN%与对照组相似。接种疫苗后CD4和CD8平均水平呈上升趋势。
尽管总IgG抗体增加幅度较小，但受试者对疫苗的中和能力反应与健康队列相似。观察到的CD4和CD8结果可能支持正在接受生物制剂治疗的患者产生有效细胞免疫反应的能力。需要开展更大规模的研究来确定这些患者的疫苗疗效。
