rAd26的安全性和免疫原性和rAd5基于矢量不同的启动—提高COVID-19疫苗在两个配方:两个开放、non-randomised 1/2期研究来自俄罗斯。

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Logunov DY, Dolzhikova IV、Zubkova OV Tukhvatullin AI, Shcheblyakov DV, Dzharullaeva, Grousova DM, Erokhova, Kovyrshina AV, Botikov AG) Izhaeva调频,罗德O, Ozharovskaya助教,Esmagambetov IB, Favorskaya IA, Zrelkin DI, Voronina DV, Shcherbinin DN, Semikhin, Simakova青年志愿,Tokarskaya EA Lubenets问,Egorova哒,Shmarov MM,尼克NA, Morozova低频,Smolyarchuk EA Kryukov EV, Babira VF, Borisevich SV, Naroditsky BS, Gintsburg

rAd26的安全性和免疫原性和rAd5基于矢量不同的启动—提高COVID-19疫苗在两个配方:两个开放、non-randomised 1/2期研究来自俄罗斯。

柳叶刀》。2020年9月3。pii: s0140 - 6736 (20) 31866 - 3。doi: 10.1016 / s0140 - 6736 (20) 31866 - 3。

PubMed ID

32896291 (在PubMed

]

文摘

背景:我们开发了一个不等的COVID-19疫苗组成的两个组件,重组腺病毒类型26 (rAd26)向量和一种重组腺病毒5 (rAd5)向量,同时携带严重急性呼吸系统综合症冠状病毒的基因2 (SARS-CoV-2)飙升糖蛋白(rAd26-S和rAd5-S)。我们的目的是评估两个配方的安全性和免疫原性(冷冻和lyophilised)的疫苗。方法:我们做了两个开放、1/2 non-randomised阶段研究在俄罗斯两家医院。我们入学年龄在18 - 60岁之间的健康成人志愿者(男性和女性)来研究。在第一阶段的研究中,我们进行肌内0天一剂rAd26-S或一剂rAd5-S和评估两个组件的安全为28天。在第二阶段的研究,开始于第一阶段接种不早于5天后,我们管理的肌内启动—提高疫苗接种,rAd26-S给天0和rAd5-S 21天。主要结果措施抗原特异体液免疫(SARS-CoV-2-specific抗体的ELISA对天0,14日,21日,28日和42)和安全(不良事件监测整个研究的参与者)。二次结果措施抗原细胞免疫(t细胞反应和移行细胞浓度)和中和抗体的变化(发现SARS-CoV-2中和试验)。这些试验是在ClinicalTrials.gov注册,NCT04436471 NCT04437875。发现:6月18日至8月3日,2020年,我们招收了76名参与者,这两项研究在每个研究(38)。 In each study, nine volunteers received rAd26-S in phase 1, nine received rAd5-S in phase 1, and 20 received rAd26-S and rAd5-S in phase 2. Both vaccine formulations were safe and well tolerated. The most common adverse events were pain at injection site (44 [58%]), hyperthermia (38 [50%]), headache (32 [42%]), asthenia (21 [28%]), and muscle and joint pain (18 [24%]). Most adverse events were mild and no serious adverse events were detected. All participants produced antibodies to SARS-CoV-2 glycoprotein. At day 42, receptor binding domain-specific IgG titres were 14 703 with the frozen formulation and 11 143 with the lyophilised formulation, and neutralising antibodies were 49.25 with the frozen formulation and 45.95 with the lyophilised formulation, with a seroconversion rate of 100%. Cell-mediated responses were detected in all participants at day 28, with median cell proliferation of 2.5% CD4(+) and 1.3% CD8(+) with the frozen formulation, and a median cell proliferation of 1.3% CD4(+) and 1.1% CD8(+) with the lyophilised formulation. INTERPRETATION: The heterologous rAd26 and rAd5 vector-based COVID-19 vaccine has a good safety profile and induced strong humoral and cellular immune responses in participants. Further investigation is needed of the effectiveness of this vaccine for prevention of COVID-19. FUNDING: Ministry of Health of the Russian Federation.

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Gam-COVID-Vac