Phase II prefusion non-stabilised Covid-19 mRNA vaccine randomised study

Author:

Puthanakit Thanyawee,Prompetchara Eakachai,Gatechompol Sivaporn,Ketloy Chutitorn,Thitithanyanont Arunee,Jongkaewwattana Anan,Buranapraditkun Supranee,Ubolyam Sasiwimol,Kerr Stephen J.,Sophonphan Jiratchaya,Apornpong Tanakorn,Kittanamongkolchai Wonngarm,Siwamogsatham Sarawut,Sriplienchan Somchai,Patarakul Kanitha,Theerawit Tuangtip,Promsena Pathariya,Nantanee Rapisa,Manomaisantiphap Siwaporn,Chokyakorn Sarun,Hong Lina,Samija Mijo,Montefiori David C.,Gao Hongmei,Eaton Amanda,Wijagkanalan Wassana,Alameh Mohamad-Gabriel,Weissman Drew,Ruxrungtham Kiat,Tawan Monta,Sutjarit Aungsumalin,Meepuksom Thutsanun,Athipunjapong Jitthiwa,Jupimai Thidarat,Moonwong Juthamanee,Nadsasarn Rachaneekorn,Khamthi Sasiprapha,Nuncharoen Pornpavee,Chanpoom Yanisar,Khamkhen Phattharapa,Narupan Nirunya,Thongthip Siriwan,Soisoongnern Konsiri,Shanyip Chomnid,Rachpradit Thanakan,Sriphraram Kanipha,Somhanwong Wassana,Boondamnern Timporn,Boonnak Nittaya,Chomchey Nitiya,Tipsuk Somporn,Puttamaswin Suwanna,Yewande Siriyapat,Lertarom Plengsri,Uanithirat Anuntaya,Anuchadbut Anongnart,Chanthaburanun Sararut,Tarawat Katawut,Mahanontharit Apicha,Sinthon Wanida,Plakunmonthonw Sasitorn,Wongmueang Suwat,Dalodom Theera,Sopa Bunruan,Phongam Nuchthida,Sri-Arunsak Anchisa,Chobkarching Umaporn,Bouko Channuwat,Junseeha Sukanya,Phuphalicho Boonsri,Pingthaisong Palida,Khlaiphuengsin Apichaya,Pararit Patcharee,Eamyoung Patcharin,Somjit Thitiporn,Iampornsin Thatri,Thongchomphunut Dutmanee,Manopwisedjaroen Suwimon,Laopanupong Thanida,Ekronarongchai Supanuch,Srisaowakarn Chanya,Jantraphakorn Yuparat,Srisutthisamphan Kanjana,Grandin Ponsuk Visudhipan,

Abstract

AbstractChulaCov19 mRNA vaccine demonstrated promising phase 1 results. Healthy adults aged 18–59 years were double-blind randomised 4:1 to receive two intramuscular doses of ChulaCov19 50 µg or placebo. Primary endpoints were safety and microneutralization antibody against-wild-type (Micro-VNT50) at day 50. One hundred fifty adults with median (IQR) age 37 (30–46) years were randomised. ChulaCov19 was well tolerated, and most adverse events were mild to moderate and temporary. Geometric mean titres (GMT) of neutralizing titre against wild-type for ChulaCov19 on day 50 were 1367 IU/mL. T-cell IFN-γ-ELISpot showed the highest responses at one week (Day29) after dose 2 then gradually declined. ChulaCov19 50 µg is well tolerated and elicited high neutralizing antibodies and strong T-cell responses in healthy adults.Trial registration number: ClinicalTrials.gov Identifier NCT04566276, 28/09/2020.

Funder

Public Donation through Covid-19 vaccine development fund of the Faculty of Medicine, Chulalongkorn University and the Thai Red Cross Society, Thailand

National Vaccine Institute

The Ratchadapisek Sompoch Endowment Fund (2021), Chulalongkorn University

Publisher

Springer Science and Business Media LLC

Subject

Multidisciplinary

Reference17 articles.

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