Safety and immunogenicity of a prefusion non-stabilized spike protein mRNA COVID-19 vaccine: a phase I trial

التفاصيل البيبلوغرافية
العنوان: Safety and immunogenicity of a prefusion non-stabilized spike protein mRNA COVID-19 vaccine: a phase I trial
المؤلفون: Sivaporn, Gatechompol, Wonngarm, Kittanamongkolchai, Chutitorn, Ketloy, Eakchai, Prompetchara, Arunee, Thitithanyanont, Anan, Jongkaewwattana, Supranee, Buranapraditkun, Mohamad-Gabriel, Alameh, Sasiwimol, Ubolyam, Jiratchaya, Sophonphan, Tanakorn, Apornpong, Stephen, Kerr, Adeeba, Kamarulzaman, Sarawut, Siwamogsatham, Eugène, Kroon, Thanyawee, Puthanakit, Kanitha, Patarakul, Tanapat, Palaga, Wassana, Wijagkanalan, Alexis, Carpenter, Lina, Hong, Drew, Weissman, Kiat, Ruxrungtham
المصدر: Nature microbiology. 7(12)
سنة النشر: 2022
مصطلحات موضوعية: Adult, COVID-19 Vaccines, SARS-CoV-2, Spike Glycoprotein, Coronavirus, Leukocytes, Mononuclear, Humans, COVID-19, RNA, Messenger, Antibodies, Viral, COVID-19 Serotherapy, Aged
الوصف: Effective mRNA SARS-CoV-2 vaccines are available but need to be stored in freezers, limiting their use to countries that have appropriate storage capacity. ChulaCov19 is a prefusion non-stabilized SARS-CoV-2 spike-protein-encoding, nucleoside-modified mRNA, lipid nanoparticle encapsulated vaccine that we report to be stable when stored at 2-8 °C for up to 3 months. Here we report safety and immunogenicity data from a phase I open-label, dose escalation, first-in-human trial of the ChulaCov19 vaccine (NCT04566276). Seventy-two eligible volunteers, 36 of whom were aged 18-55 (adults) and 36 aged 56-75 (elderly), were enroled. Two doses of vaccine were administered 21 d apart at 10, 25 or 50 μg per dose (12 per group). The primary outcome was safety and the secondary outcome was immunogenicity. All three dosages of ChulaCov19 were well tolerated and elicited robust dose-dependent and age-dependent B- and T-cell responses. Transient mild/moderate injection site pain, fever, chills, fatigue and headache were more common after the second dose. Four weeks after the second dose, in the adult cohort, MicroVNT-50 geometric mean titre against wild-type SARS-CoV-2 was 848 (95% CI, 483-1,489), 736 (459-1,183) and 1,140 (854-1,522) IU ml
تدمد: 2058-5276
الوصول الحر: https://explore.openaire.eu/search/publication?articleId=pmid________::0b4e5cee877df36abae9dcb05f69823eTest
https://pubmed.ncbi.nlm.nih.gov/36376393Test
رقم الانضمام: edsair.pmid..........0b4e5cee877df36abae9dcb05f69823e
قاعدة البيانات: OpenAIRE