Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia

Logunov Denis Y.; Dolzhikova Inna V.; Shcheblyakov Dmitry V.; Tukhvatulin Amir I.; Zubkova Olga V.; Dzharullaeva Alina S.; Kovyrshina Anna V.; Lubenets Nadezhda L.; Grousova Daria M.; Erokhova Alina S.; Botikov Andrei G.; Izhaeva Fatima M.; Popova Olga; Ozharovskaya Tatiana A.; Esmagambetov Ilias B.; Favorskaya Irina A.; Zrelkin Denis I.; Voronina Daria V.; Shcherbinin Dmitry N.; Semikhin Alexander S.; Simakova Yana V.; Tokarskaya Elizaveta A.; Egorova Daria A.; Shmarov Maksim M.; Nikitenko Natalia A.; Gushchin Vladimir A.; Smolyarchuk Elena A.; Zyryanov Sergey K.; Borisevich Sergei V.; Naroditsky Boris S.; Gintsburg Alexander L.

首页> 外文期刊>The Lancet >Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia

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Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia

机译：RAD26和基于RAD5载体的异源素质促进Covid-19疫苗的安全性和有效性：俄罗斯随机对照第3阶段试验的临时分析

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Background A heterologous recombinant adenovirus (rAd)-based vaccine, Gam-COVID-Vac (Sputnik V), showed a good safety profile and induced strong humoral and cellular immune responses in participants in phase 1/2 clinical trials. Here, we report preliminary results on the efficacy and safety of Gam-COVID-Vac from the interim analysis of this phase 3 trial.

机译：背景：一种基于异源重组腺病毒（rAd）的疫苗Gam-COVID Vac（Sputnik V）在1/2期临床试验的参与者中显示出良好的安全性，并诱导强烈的体液和细胞免疫应答。在这里，我们报告了关于Gam-COVID Vac的疗效和安全性的初步结果，这些结果来自于该3期试验的中期分析。

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《The Lancet》 |2021年第10275期|共11页
作者
Logunov Denis Y.; Dolzhikova Inna V.; Shcheblyakov Dmitry V.; Tukhvatulin Amir I.; Zubkova Olga V.; Dzharullaeva Alina S.; Kovyrshina Anna V.; Lubenets Nadezhda L.; Grousova Daria M.; Erokhova Alina S.; Botikov Andrei G.; Izhaeva Fatima M.; Popova Olga; Ozharovskaya Tatiana A.; Esmagambetov Ilias B.; Favorskaya Irina A.; Zrelkin Denis I.; Voronina Daria V.; Shcherbinin Dmitry N.; Semikhin Alexander S.; Simakova Yana V.; Tokarskaya Elizaveta A.; Egorova Daria A.; Shmarov Maksim M.; Nikitenko Natalia A.; Gushchin Vladimir A.; Smolyarchuk Elena A.; Zyryanov Sergey K.; Borisevich Sergei V.; Naroditsky Boris S.; Gintsburg Alexander L.;
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作者单位

Minist Hlth Russian Federat Fed State Budget Inst Natl Res Ctr Epidemiol &

Microbiol Moscow;

Minist Hlth Russian Federat Fed State Budget Inst Natl Res Ctr Epidemiol &

Microbiol Moscow;

Minist Hlth Russian Federat Fed State Budget Inst Natl Res Ctr Epidemiol &

Microbiol Moscow;

Minist Hlth Russian Federat Fed State Budget Inst Natl Res Ctr Epidemiol &

Microbiol Moscow;

Minist Hlth Russian Federat Fed State Budget Inst Natl Res Ctr Epidemiol &

Microbiol Moscow;

Minist Hlth Russian Federat Fed State Budget Inst Natl Res Ctr Epidemiol &

Microbiol Moscow;

Minist Hlth Russian Federat Fed State Budget Inst Natl Res Ctr Epidemiol &

Microbiol Moscow;

Minist Hlth Russian Federat Fed State Budget Inst Natl Res Ctr Epidemiol &

Microbiol Moscow;

Minist Hlth Russian Federat Fed State Budget Inst Natl Res Ctr Epidemiol &

Microbiol Moscow;

Minist Hlth Russian Federat Fed State Budget Inst Natl Res Ctr Epidemiol &

Microbiol Moscow;

Minist Hlth Russian Federat Fed State Budget Inst Natl Res Ctr Epidemiol &

Microbiol Moscow;

Minist Hlth Russian Federat Fed State Budget Inst Natl Res Ctr Epidemiol &

Microbiol Moscow;

Minist Hlth Russian Federat Fed State Budget Inst Natl Res Ctr Epidemiol &

Microbiol Moscow;

Minist Hlth Russian Federat Fed State Budget Inst Natl Res Ctr Epidemiol &

Microbiol Moscow;

Minist Hlth Russian Federat Fed State Budget Inst Natl Res Ctr Epidemiol &

Microbiol Moscow;

Minist Hlth Russian Federat Fed State Budget Inst Natl Res Ctr Epidemiol &

Microbiol Moscow;

Minist Hlth Russian Federat Fed State Budget Inst Natl Res Ctr Epidemiol &

Microbiol Moscow;

Minist Hlth Russian Federat Fed State Budget Inst Natl Res Ctr Epidemiol &

Microbiol Moscow;

Minist Hlth Russian Federat Fed State Budget Inst Natl Res Ctr Epidemiol &

Microbiol Moscow;

Minist Hlth Russian Federat Fed State Budget Inst Natl Res Ctr Epidemiol &

Microbiol Moscow;

Minist Hlth Russian Federat Fed State Budget Inst Natl Res Ctr Epidemiol &

Microbiol Moscow;

Minist Hlth Russian Federat Fed State Budget Inst Natl Res Ctr Epidemiol &

Microbiol Moscow;

Minist Hlth Russian Federat Fed State Budget Inst Natl Res Ctr Epidemiol &

Microbiol Moscow;

Minist Hlth Russian Federat Fed State Budget Inst Natl Res Ctr Epidemiol &

Microbiol Moscow;

Sechenov Univ IM Sechenov First Moscow State Med Univ Minist Hlth Russian Federat Fed State;

RUDN Univ Peoples Friendship Univ Russia Moscow Russia;

Minist Def Russian Federat Cent Res Inst 48 Moscow Russia;

Minist Hlth Russian Federat Fed State Budget Inst Natl Res Ctr Epidemiol &

Microbiol Moscow;

Minist Hlth Russian Federat Fed State Budget Inst Natl Res Ctr Epidemiol &

Microbiol Moscow;

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正文语种 eng
中图分类医药、卫生;
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1. Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia (vol 397, pg 671, 2021) [J] . Logunov D. Y., Dolzhikova I. V, Shcheblyakov D. V The Lancet . 2021,第10275期

机译：RAD26和RAD5基于载体的异源素质 - 增压Covid-19疫苗的安全性和有效性：俄罗斯随机对照第3阶段试验的临时分析（Vol 397，PG 671,2021）
2. Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia (vol 396, pg 887, 2020) [J] . Logunov D. Y., Dolzhikova I. V, Zubkova O. V The Lancet . 2021,第10269期

机译：rad26和rad5载体的异源素母型促进咖啡酰-19两种配方的安全性和免疫原性：来自俄罗斯的两个开放式，非随机阶段1/2研究（Vol 396，PG 887,2020）
3. Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey [J] . Tanriover Mine Durusu, Doganay Hamdi Levent, Akova Murat, The Lancet . 2021,第10296期

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4. The best evidence: A randomised controlled trial to assess the efficacy of a nutraceutical to treat headshaking [C] . Gina L. Pinchbeck British Equine Veterinary Association Congress . 2009

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5. Efficacy and safety of novel collagen conduits filled with collagen filaments to treat patients with peripheral nerve injury: A multicenter, controlled, open-label clinical trial [D] . Saeki Masaomi, 佐伯将臣 2019

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6. A randomized double-blind placebo-controlled phase III clinical trial to evaluate the efficacy and safety of SARS-CoV-2 vaccine (inactivated Vero cell): a structured summary of a study protocol for a randomised controlled trial [O] . Murat Akova, Serhat Unal 2021

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7. Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia [O] . Denis Y Logunov, Inna V Dolzhikova, Olga V Zubkova, 2020

机译：rad26和rad5载体的异源素母素升压Covid-19的安全性和免疫原性两种配方：来自俄罗斯的两个开放，非随机化阶段1/2研究
8. Chenodiol (Chenodeoxycholic Acid) for Dissolution of Gallstones. The National Cooperative Gallstone Study: A Controlled Trial of Efficacy and Safety (Detailed Statistical Analyses for the Manuscript) [R] . Schoenfield, L. J. , Lachin, J. M. 1981

机译：Chenodiol（Chenodeoxycholic acid）用于溶解胆结石。国家合作性胆结石研究：功效和安全性的对照试验（手稿的详细统计分析）

Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia

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