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

  • Back
    bibtex

Document Title

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

Author

Puthanakit T. Prompetchara E. Gatechompol S. Ketloy C. Thitithanyanont A. Jongkaewwattana A. Buranapraditkun S. Ubolyam S. Kerr S.J. Sophonphan J. Apornpong T. Kittanamongkolchai W. Siwamogsatham S. Sriplienchan S. Patarakul K. Theerawit T. Promsena P. Nantanee R. Manomaisantiphap S. Chokyakorn S. Hong L. Samija M. Montefiori D.C. Gao H. Eaton A. Wijagkanalan W. Alameh M.-G. Weissman D. Ruxrungtham K. Tawan M. Sutjarit A. Meepuksom T. Athipunjapong J. Jupimai T. Moonwong J. Nadsasarn R. Khamthi S. Nuncharoen P. Chanpoom Y. Khamkhen P. Narupan N. Thongthip S. Soisoongnern K. Shanyip C. Rachpradit T. Sriphraram K. Somhanwong W. Boondamnern T. Boonnak N. Chomchey N. Tipsuk S. Puttamaswin S. Yewande S. Lertarom P. Uanithirat A. Anuchadbut A. Chanthaburanun S. Tarawat K. Mahanontharit A. Sinthon W. Plakunmonthonw S. Wongmueang S. Dalodom T. Sopa B. Phongam N. Sri-Arunsak A. Chobkarching U. Bouko C. Junseeha S. Phuphalicho B. Pingthaisong P. Khlaiphuengsin A. Pararit P. Eamyoung P. Somjit T. Iampornsin T. Thongchomphunut D. Manopwisedjaroen S. Laopanupong T. Ekronarongchai S. Srisaowakarn C. Jantraphakorn Y. Srisutthisamphan K. Grandin P.V.

Affiliations

Department of Pediatrics Faculty of Medicine Chulalongkorn University Bangkok Thailand; Center of Excellent for Pediatric Infectious Diseases and Vaccines Faculty of Medicine Chulalongkorn University Bangkok Thailand; Maha Chakri Sirindhorn Clinical Research Center (ChulaCRC) Faculty of Medicine Chulalongkorn University Bangkok Thailand; Center of Excellence in Vaccine Research and Development (Chula VRC) Faculty of Medicine Chulalongkorn University Bangkok Thailand; Department of Laboratory Medicine Faculty of Medicine Chulalongkorn University Bangkok Thailand; School of Global Health Faculty of Medicine Chulalongkorn University Bangkok Thailand; Center of Excellence in Tuberculosis Faculty of Medicine Chulalongkorn University Bangkok Thailand; HIV-NAT Thai Red Cross AIDS Research Centre Bangkok Thailand; Department of Microbiology Faculty of Science Mahidol University Bangkok Thailand; Virology and Cell Technology Research Team National Center for Genetic Engineering and Biotechnology (BIOTEC) National Science and Technology Development Agency (NSTDA) Pathum Thani Thailand; Department of Medicine Faculty of Medicine Chulalongkorn University Bangkok Thailand; Clinical Research Laboratory/HIV-NAT Laboratory ChulaCRC Faculty of Medicine Chulalongkorn University Bangkok Thailand; Biostatistics Excellence Centre Faculty of Medicine Chulalongkorn University Bangkok Thailand; Biostatistics Unit HIVNAT Thai Red Cross AIDS Research Centre Bangkok Thailand; The Kirby Institute University of New South Wales Sydney Australia; SEARCH Research Foundation Bangkok Thailand; Department of Microbiology Faculty of Medicine Chulalongkorn University Bangkok Thailand; Department of Pharmacology Faculty of Medicine Chulalongkorn University Bangkok Thailand; Genevant Sciences Corporation Vancouver BC Canada; Department of Surgery Duke University Medical Center Durham NC United States; BioNet Asia Co. Ltd. Bangkok Thailand; Perelman School of Medicine University of Pennsylvania Philadelphia PA United States; Armed Forces Research Institute of Medical Sciences Bangkok Thailand

Type

Article

Source Title

Scientific Reports

ISSN

20452322

Year

2024

Volume

14

Issue

1

Open Access

All Open Access Gold

Publisher

Nature Research

DOI

10.1038/s41598-023-49653-6

Abstract

ChulaCov19 mRNA vaccine demonstrated promising phase 1 results. Healthy adults aged 18�爕ears were double-blind randomised 4:1 to receive two intramuscular doses of ChulaCov19 50�g 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�) 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營U/mL. T-cell IFN-?-ELISpot showed the highest爎esponses燼t one week (Day29) after dose 2 then gradually declined. ChulaCov19 50�g 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. ? 2024 The Author(s).

License

CC BY

Rights

Authors

Publication Source

WOS

Continue browsing