Boshku Aleksandra Atanasova, Aleksovski Vasko, Tofoski Gligor, Spasova Rosa
University Clinic of Gynecology and Obstetrics, Faculty of Medicine, Ss. Cyril and Methodius University Skopje, Skopje, North Macedonia.
University Clinic of Neurology, Faculty of Medicine, Ss. Cyril and Methodius University Skopje, Skopje, North Macedonia.
EJIFCC. 2022 Aug 8;33(2):175-186. eCollection 2022 Aug.
Widespread vaccination is considered as one of the best methods in combating any pandemic including COVID-19. Gam-COVID-Vac also known as Sputnik V, is one of the first vaccines that was registered in 74 countries and received an emergency approval for immunization. Monitoring anti-SARS-CoV-2 antibodies over time is essential for evaluation of post-vaccination humoral immune response.To date, there are only a limited number of clinical studies regarding the analysis of immune response after Sputnik V administration. It is of crucial importance to report independently on safety and efficiency of this vaccine with the aim to speed up the process of its final approval by the WHO.
Humoral immune response was monitored by seven immunoassays to analyze different classes of anti-SARS-CoV-2 Ig in five health workers after receiving the combined vector vaccination. This vaccine is based on two replication-deficient rAd26 and rAd5 viral vectors that carry the gene SARS-CoV-2 full-length glycoprotein S(rAd26-S and rAd5-S). Sputnik V was administered with a 21-day interval between the first and second dose. Venous blood was collected two hours before vaccination as a baseline, and then followed by 18 series up to 170-day post-vaccination.
The participants in this study used a self-report form in which they noted their observations on safety at 72 h post-immunization. One participant reported mild side effects, such as muscle pain and fever, while the other four individuals had no noticeable complications. Seroconversion was detected in all individuals at 28 days of post-vaccination. Plateau of seropositivity has been achieved by 50th day of vaccination, while titer values decreased after 6 months.
This study provides some clinical data regarding the kinetics of antibody levels elicited after administration of heterologous rAd26-S and rAd5-S vaccine. Based on the preliminary data from this pilot study, it appears that Sputnik V vaccine generates a solid humoral immune response lasting at least 6 months after immunization.
广泛接种疫苗被认为是对抗包括新冠疫情在内的任何大流行病的最佳方法之一。加马新冠疫苗(Gam-COVID-Vac),也被称为卫星五号疫苗(Sputnik V),是首批在74个国家注册并获得免疫紧急批准的疫苗之一。长期监测抗SARS-CoV-2抗体对于评估疫苗接种后的体液免疫反应至关重要。迄今为止,关于卫星五号疫苗接种后免疫反应分析的临床研究数量有限。独立报告该疫苗的安全性和有效性对于加快其获得世界卫生组织最终批准的进程至关重要。
通过七种免疫测定法监测五名医护人员在接种联合载体疫苗后体液免疫反应,以分析不同类别的抗SARS-CoV-2 Ig。该疫苗基于两种复制缺陷型rAd26和rAd5病毒载体,它们携带SARS-CoV-2全长糖蛋白S基因(rAd26-S和rAd5-S)。卫星五号疫苗的首剂和第二剂接种间隔为21天。在接种前两小时采集静脉血作为基线,然后在接种后长达170天进行18次后续采血。
本研究的参与者使用了一份自我报告表格,记录他们在免疫接种后72小时的安全观察情况。一名参与者报告了轻微副作用,如肌肉疼痛和发烧,而其他四人没有明显并发症。所有个体在接种后28天检测到血清转化。在接种后第50天达到血清阳性平台期,而滴度值在6个月后下降。
本研究提供了一些关于接种异源rAd26-S和rAd5-S疫苗后抗体水平动力学的临床数据。基于这项初步研究的初步数据,卫星五号疫苗似乎能产生持续至少6个月的强烈体液免疫反应。