Scientific Reports (Jan 2024)
Phase II prefusion non-stabilised Covid-19 mRNA vaccine randomised study
- Thanyawee Puthanakit,
- Eakachai Prompetchara,
- Sivaporn Gatechompol,
- Chutitorn Ketloy,
- Arunee Thitithanyanont,
- Anan Jongkaewwattana,
- Supranee Buranapraditkun,
- Sasiwimol Ubolyam,
- Stephen J. Kerr,
- Jiratchaya Sophonphan,
- Tanakorn Apornpong,
- Wonngarm Kittanamongkolchai,
- Sarawut Siwamogsatham,
- Somchai Sriplienchan,
- Kanitha Patarakul,
- Tuangtip Theerawit,
- Pathariya Promsena,
- Rapisa Nantanee,
- Siwaporn Manomaisantiphap,
- Sarun Chokyakorn,
- Lina Hong,
- Mijo Samija,
- David C. Montefiori,
- Hongmei Gao,
- Amanda Eaton,
- Wassana Wijagkanalan,
- Mohamad-Gabriel Alameh,
- Drew Weissman,
- Kiat Ruxrungtham,
- ChulaVac001-Phase 2 study team
Affiliations
- Thanyawee Puthanakit
- Department of Pediatrics, Faculty of Medicine, Chulalongkorn University
- Eakachai Prompetchara
- Center of Excellence in Vaccine Research and Development (Chula VRC), Faculty of Medicine, Chulalongkorn University
- Sivaporn Gatechompol
- School of Global Health, Faculty of Medicine, Chulalongkorn University
- Chutitorn Ketloy
- Center of Excellence in Vaccine Research and Development (Chula VRC), Faculty of Medicine, Chulalongkorn University
- Arunee Thitithanyanont
- Department of Microbiology, Faculty of Science, Mahidol University
- Anan Jongkaewwattana
- Virology and Cell Technology Research Team, National Center for Genetic Engineering and Biotechnology (BIOTEC), National Science and Technology Development Agency (NSTDA)
- Supranee Buranapraditkun
- Center of Excellence in Vaccine Research and Development (Chula VRC), Faculty of Medicine, Chulalongkorn University
- Sasiwimol Ubolyam
- Clinical Research Laboratory/HIV-NAT Laboratory, ChulaCRC, Faculty of Medicine, Chulalongkorn University
- Stephen J. Kerr
- Biostatistics Excellence Centre, Faculty of Medicine, Chulalongkorn University
- Jiratchaya Sophonphan
- Biostatistics Unit, HIVNAT, Thai Red Cross AIDS Research Centre
- Tanakorn Apornpong
- Biostatistics Unit, HIVNAT, Thai Red Cross AIDS Research Centre
- Wonngarm Kittanamongkolchai
- Maha Chakri Sirindhorn Clinical Research Center (ChulaCRC), Faculty of Medicine, Chulalongkorn University
- Sarawut Siwamogsatham
- Maha Chakri Sirindhorn Clinical Research Center (ChulaCRC), Faculty of Medicine, Chulalongkorn University
- Somchai Sriplienchan
- SEARCH Research Foundation
- Kanitha Patarakul
- Center of Excellence in Vaccine Research and Development (Chula VRC), Faculty of Medicine, Chulalongkorn University
- Tuangtip Theerawit
- Center of Excellent for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University
- Pathariya Promsena
- Center of Excellent for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University
- Rapisa Nantanee
- Department of Pediatrics, Faculty of Medicine, Chulalongkorn University
- Siwaporn Manomaisantiphap
- Department of Pharmacology, Faculty of Medicine, Chulalongkorn University
- Sarun Chokyakorn
- Department of Pharmacology, Faculty of Medicine, Chulalongkorn University
- Lina Hong
- Genevant Sciences Corporation
- Mijo Samija
- Genevant Sciences Corporation
- David C. Montefiori
- Department of Surgery, Duke University Medical Center
- Hongmei Gao
- Department of Surgery, Duke University Medical Center
- Amanda Eaton
- Department of Surgery, Duke University Medical Center
- Wassana Wijagkanalan
- BioNet Asia, Co. Ltd.
- Mohamad-Gabriel Alameh
- Perelman School of Medicine, University of Pennsylvania
- Drew Weissman
- Perelman School of Medicine, University of Pennsylvania
- Kiat Ruxrungtham
- Center of Excellence in Vaccine Research and Development (Chula VRC), Faculty of Medicine, Chulalongkorn University
- ChulaVac001-Phase 2 study team
- DOI
- https://doi.org/10.1038/s41598-023-49653-6
- Journal volume & issue
-
Vol. 14,
no. 1
pp. 1 – 10
Abstract
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.
