Moderna, Cambridge, Massachusetts, USA.
Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
J Infect Dis. 2024 Sep 23;230(3):e591-e600. doi: 10.1093/infdis/jiae140.
Solid organ transplant recipients (SOTRs) are at high risk for severe COVID-19.
This open-label, phase 3b trial evaluated mRNA-1273 in 137 kidney and 77 liver SOTRs and 20 immunocompetent participants. In part A, SOTRs received three 100-µg doses of mRNA-1273; immunocompetent participants received 2 doses. In part B, an additional 100-µg dose was offered ≥4 months after the primary series. Here, we report interim trial results.
mRNA-1273 was well-tolerated in SOTRs. Four serious adverse events were considered vaccine related by the investigator in 3 SOTRs with preexisting comorbidities. No vaccine-related biopsy-proven organ rejection events or deaths were reported. mRNA-1273 elicited modest neutralizing antibody responses after dose 2 and improved responses after dose 3 in SOTRs. Post-dose 3 responses among liver SOTRs were comparable to post-dose 2 responses in immunocompetent participants. Post-additional dose responses were increased in SOTRs, regardless of primary series vaccination. In liver SOTRs, post-additional dose responses were ∼3-fold higher versus post-dose 2 but lower than immunocompetent participant responses. Most kidney SOTRs received multiple immunosuppressants and had reduced antibody responses versus liver SOTRs.
mRNA-1273 was well-tolerated, and dose 3 and the additional dose improved antibody responses among SOTRs.
NCT04860297.
实体器官移植受者（SOTR）患严重 COVID-19 的风险很高。
这项开放标签、3b 期临床试验评估了 mRNA-1273 在 137 例肾和 77 例肝 SOTR 以及 20 例免疫功能正常的参与者中的疗效。在 A 部分，SOTR 接受了三剂 100μg 的 mRNA-1273；免疫功能正常的参与者接受了两剂。在 B 部分，在初级系列完成后≥4 个月提供了额外的 100μg 剂量。在此，我们报告了中期试验结果。
mRNA-1273 在 SOTR 中耐受性良好。在 3 名有预先存在的合并症的 SOTR 中，研究者认为有 4 例严重不良事件与疫苗有关。未报告与疫苗相关的活检证实的器官排斥事件或死亡。SOTR 在接受第 2 剂后产生了适度的中和抗体反应，在接受第 3 剂后反应增强。肝 SOTR 接受第 3 剂后的反应与免疫功能正常的参与者接受第 2 剂后的反应相当。接受额外剂量的反应在 SOTR 中增加，无论初级系列疫苗接种情况如何。在肝 SOTR 中，接受额外剂量的反应比第 2 剂高约 3 倍，但低于免疫功能正常的参与者的反应。大多数肾 SOTR 接受了多种免疫抑制剂治疗，与肝 SOTR 相比，抗体反应降低。
mRNA-1273 耐受性良好，第 3 剂和额外剂量可提高 SOTR 的抗体反应。
NCT04860297。
