Medigen Vaccine Biologics Corporation, Taipei, Taiwan; Institute of Public Health, National Yang Ming Chiao Tung University, Taipei, Taiwan.
College of Medicine, Chang Gung University, Taoyuan, Taiwan; Department of Family Medicine, Chang Gung Memorial Hospital Linkou Branch, Taoyuan City, Taiwan.
Int J Infect Dis. 2022 Nov;124:21-26. doi: 10.1016/j.ijid.2022.08.021. Epub 2022 Aug 29.
Older adults are subject to higher COVID-19 infection and mortality rates. Safety and immunogenicity of MVC-COV1901, a protein subunit vaccine have been demonstrated in phase 2 clinical trial for the general population, and negative correlations have been observed between immune responses and age, however, older adults were under-represented.
A double-blind, randomized, multi-center study compared safety and immunogenicity of high-dose (25 mcg) to mid-dose (15 mcg) of MVC-COV1901 administered 2 times 28 days apart in 420 participants of 65 years and older. The results have been stratified by the comorbidity status.
Both high and mid-dose regimens elicited mostly mild adverse events and robust immune responses when measured as neutralizing and binding antibodies titers. High doses elicited better immune responses in the group without comorbidities.
Given the general population-associated safety and immunogenicity of MVC-COV1901, we recommend high dose for immunization of elder adults with MVC-COV1901. The clinical trial was registered at https://clinicaltrials.gov/ (NCT04822025).
老年人更容易感染 COVID-19 并因此死亡。在针对普通人群的 2 期临床试验中，MVC-COV1901（一种蛋白亚单位疫苗）已被证明具有安全性和免疫原性，并且观察到免疫反应与年龄之间呈负相关，但老年人的代表性不足。
一项双盲、随机、多中心研究比较了高剂量（25 mcg）和中剂量（15 mcg）MVC-COV1901 在 420 名 65 岁及以上参与者中每 28 天接种 2 次的安全性和免疫原性。结果按合并症状况进行分层。
高剂量和中剂量方案均引起了大多数轻微的不良反应，并产生了中和抗体和结合抗体滴度的强烈免疫反应。高剂量在无合并症组中产生了更好的免疫反应。
鉴于 MVC-COV1901 与普通人群相关的安全性和免疫原性，我们建议使用高剂量为 MVC-COV1901 免疫接种老年人。临床试验注册于 https://clinicaltrials.gov/（NCT04822025）。
