应对产品短缺的异源新型冠状病毒疫苗接种方案的安全性和免疫原性：一项针对老年人群的随机临床试验
Safety and immunogenicity of heterologous COVID-19 vaccine regimens to deal with product shortage: A randomised clinical trial in an elderly population.
作者信息
Kundro M A, Losso M H, Macchia A, Pastor I, Alonso Serena M, Gestoso C, Moreno Macías L, Crupi F, Acosta M C, Ivalo S, Ghioldi M, Bouzas M B, Mammana L, Zapiola I, Mazzitelli I, Varese A, Geffner J, Biscayart C, Angeleri P, Lopez E, Gentile A, Ferrante D, de Quiros F Gonzalez B
机构信息
Área de Investigación en Enfermedades Emergentes, Hospital General de Agudos "J.M. Ramos Mejía", Ciudad Autónoma de Buenos Aires, Argentina.
Ministerio de Salud del Gobierno de la Ciudad Autónoma de Buenos Aires, Argentina.
出版信息
Public Health Pract (Oxf). 2022 Dec;4:100313. doi: 10.1016/j.puhip.2022.100313. Epub 2022 Sep 6.
OBJECTIVES
In a context of COVID-19 vaccine shortages, this study sought to evaluate the safety and efficacy of receiving one dose of Gam-COVID-Vac rAd26 followed by a second COVID-19 vaccine dose of either Gam-COVID-Vac rAd5, ChAdOx1 nCoV-19 or BBIBP-CorV in a cohort of older adults.
STUDY DESIGN
Single-centre, randomised, open label, non-inferiority trial.
METHODS
Adults aged ≥65 years who had received one dose of Gam-COVID-Vac rAd26 were randomised in a 1:1:1 ratio to receive a second-dose COVID-19 vaccination of either Gam-COVID-Vac rAd5, ChAdOx1 nCoV-19 or BBIBP-CorV. The primary outcome was the assessment of the humoral immune response to vaccination (i.e. antibody titres of SARS-CoV-2 spike protein at 28 days after second-dose vaccination). In addition, neutralising antibody titres at day 28 for the three schedules were measured.
RESULTS
Of 85 participants who were enrolled in the study between 26 and July 30, 2021, 31 individuals were randomised to receive Gam-COVID-Vac rAd5, 27 to ChAdOx1 nCoV-19 and 27 to BBIBP-CorV. The mean age of participants was 68.2 years (SD 2.9) and 49 (57.6%) were female. Participants who received Gam-COVID-Vac rAd5 and ChAdOx1 nCoV1-19 showed significantly increased anti-S titres at 28 days after second-dose vaccination, but this magnitude of difference was not observed for those who received BBIBP-CorV. The ratio between the geometric mean at day 28 and baseline within each group was 11.8 (6.98-19.89) among patients assigned to Gam-COVID-Vac rAd26/rAd5, 4.81 (2.14-10.81) for the rAd26/ChAdOx1 nCoV-19 group and 1.53 (0.74-3.20) for the rAd26/BBIBP-CorV group. All of the schedules were shown to be safe.
CONCLUSIONS
The findings in this study contribute to the scarce information published on the safety and immunogenicity of Gam-COVID-Vac heterologous regimens and will help the development of guidelines and vaccine programme management.
目的
在新冠疫苗短缺的背景下，本研究旨在评估在一组老年人中接种一剂腺病毒载体新冠疫苗（Gam-COVID-Vac rAd26），随后再接种一剂新冠疫苗（Gam-COVID-Vac rAd5、ChAdOx1 nCoV-19或BBIBP-CorV）的安全性和有效性。
研究设计
单中心、随机、开放标签、非劣效性试验。
方法
年龄≥65岁且已接种一剂Gam-COVID-Vac rAd26的成年人按1:1:1的比例随机分组，分别接受第二剂新冠疫苗Gam-COVID-Vac rAd5、ChAdOx1 nCoV-19或BBIBP-CorV接种。主要结局是评估接种疫苗后的体液免疫反应（即第二剂接种后28天的新冠病毒刺突蛋白抗体滴度）。此外，还测量了三种接种方案在第28天的中和抗体滴度。
结果
在2021年6月26日至7月30日期间纳入该研究的85名参与者中，31人被随机分配接受Gam-COVID-Vac rAd5，27人接受ChAdOx1 nCoV-19，27人接受BBIBP-CorV。参与者的平均年龄为68.2岁（标准差2.9），女性49人（57.6%）。接受Gam-COVID-Vac rAd5和ChAdOx1 nCoV1-19的参与者在第二剂接种后28天的抗S滴度显著升高，但接受BBIBP-CorV的参与者未观察到这种差异程度。在分配接受Gam-COVID-Vac rAd26/rAd5的患者中，每组第28天的几何平均值与基线值之比为11.8（6.98-19.89），rAd26/ChAdOx1 nCoV-19组为4.81（2.14-10.81），rAd26/BBIBP-CorV组为1.53（0.74-3.20）。所有接种方案均显示安全。
结论
本研究结果为腺病毒载体新冠疫苗异源接种方案的安全性和免疫原性方面的稀缺信息做出了贡献，并将有助于制定指南和疫苗项目管理。
Zotero 插件