une première publication confirme des résultats préliminaires encourageants

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  • Vaccin russe contre le Covid-19 : une première publication confirme des résultats préliminaires encourageants
    https://www.lemonde.fr/planete/article/2020/09/04/vaccin-russe-une-premiere-publication-confirme-des-resultats-preliminaires-e

    Ces résultats ne prouvent pas encore que le vaccin protège efficacement contre une infection par le nouveau coronavirus, souligne toutefois l’étude publiée vendredi dans la revue britannique « The Lancet ».

    Une étude préliminaire, publiée vendredi 4 septembre, montre que le vaccin contre le nouveau coronavirus en cours de développement en Russie déclenche bien une réponse immunitaire et n’a pas entraîné d’effets indésirables graves, ce qu’avait affirmé le gouvernement russe il y a un mois, mais sans publier ses données. Ces résultats ne prouvent pas encore que le vaccin protège efficacement contre une infection par le nouveau coronavirus, ce que devront encore montrer des études de plus grande ampleur, soulignent toutefois des experts.

    • 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
      https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31866-3/abstract

      Summary

      Background
      We developed a heterologous COVID-19 vaccine consisting of two components, a recombinant adenovirus type 26 (rAd26) vector and a recombinant adenovirus type 5 (rAd5) vector, both carrying the gene for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike glycoprotein (rAd26-S and rAd5-S). We aimed to assess the safety and immunogenicity of two formulations (frozen and lyophilised) of this vaccine.

      Methods
      We did two open, non-randomised phase 1/2 studies at two hospitals in Russia. We enrolled healthy adult volunteers (men and women) aged 18–60 years to both studies. In phase 1 of each study, we administered intramuscularly on day 0 either one dose of rAd26-S or one dose of rAd5-S and assessed the safety of the two components for 28 days. In phase 2 of the study, which began no earlier than 5 days after phase 1 vaccination, we administered intramuscularly a prime-boost vaccination, with rAd26-S given on day 0 and rAd5-S on day 21. Primary outcome measures were antigen-specific humoral immunity (SARS-CoV-2-specific antibodies measured by ELISA on days 0, 14, 21, 28, and 42) and safety (number of participants with adverse events monitored throughout the study). Secondary outcome measures were antigen-specific cellular immunity (T-cell responses and interferon-γ concentration) and change in neutralising antibodies (detected with a SARS-CoV-2 neutralisation assay). These trials are registered with ClinicalTrials.gov, NCT04436471 and NCT04437875.

      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.

      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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