Phase II prefusion non-stabilised Covid-19 mRNA vaccine randomised study
Issued Date
2024-12-01
Resource Type
eISSN
20452322
Scopus ID
2-s2.0-85183624400
Journal Title
Scientific Reports
Volume
14
Issue
1
Rights Holder(s)
SCOPUS
Bibliographic Citation
Scientific Reports Vol.14 No.1 (2024)
Suggested Citation
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. Phase II prefusion non-stabilised Covid-19 mRNA vaccine randomised study. Scientific Reports Vol.14 No.1 (2024). doi:10.1038/s41598-023-49653-6 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/95914
Title
Phase II prefusion non-stabilised Covid-19 mRNA vaccine randomised study
Author(s)
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.
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.
Author's Affiliation
Duke University Medical Center
The Kirby Institute
The HIV Netherlands Australia Thailand Research Collaboration
Armed Forces Research Institute of Medical Sciences, Thailand
Mahidol University
Thailand National Center for Genetic Engineering and Biotechnology
University of Pennsylvania Perelman School of Medicine
Faculty of Medicine, Chulalongkorn University
Genevant Sciences Corporation
Co. Ltd.
SEARCH
The Kirby Institute
The HIV Netherlands Australia Thailand Research Collaboration
Armed Forces Research Institute of Medical Sciences, Thailand
Mahidol University
Thailand National Center for Genetic Engineering and Biotechnology
University of Pennsylvania Perelman School of Medicine
Faculty of Medicine, Chulalongkorn University
Genevant Sciences Corporation
Co. Ltd.
SEARCH
Corresponding Author(s)
Other Contributor(s)
Abstract
ChulaCov19 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.