Fort.media/Цитаты/22

Findings Between June 18 and Aug 3, 2020, we enrolled 76 participants to the two studies (38 in each study). 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.

Иммунитет на 42 день

14 сентября 2020 года

На 42 день рецепторные связывания доменных Igg титров были 14703 с замороженным составом и 11143 с лиофилизированным составом, а нейтрализующие антитела были 49 25 с замороженным составом и 45 95 с лиофилизированным составом, с сероконверсией 100%. Клеточно-опосредованные реакции были обнаружены у всех участников в день 28, при медианном пролиферации клеток 2 5% CD4+ и 1 3% CD8+ с замороженным составом, а медианное пролиферация клеток 1 3% CD4+ и 1 1% CD8+ с лиофилизированным составом.

Fort.media

/ 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 / The LANCET /   

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COVID-19, Эпидемия, Вакцина, КИ, SARS-CoV-2, Результат