Evidence map›Paper›PMID 38287068›Full record

Trial reportScientific reports2024

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 and 20 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Scientific reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04566276 (A Phase 1/2, Dose-finding Study to Evaluate Safety, Tolerability, and Immunogenicity of the ChulaCov19 Vaccine in Healthy Adults), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04566276 phase1 / phase2completednot on this map

A Phase 1/2, Dose-finding Study to Evaluate Safety, Tolerability, and Immunogenicity of the ChulaCov19 Vaccine in Healthy Adults

TypeinterventionalSponsorChulalongkorn UniversityRan2021 to 2022Enrolled192ConditionsCOVID-19 Vaccine, Safety IssuesArmsChulaCov19 vaccine, Placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Harnessing Nanocarriers to Advance Vaccine Development.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

30 authors.

Thanyawee Puthanakit *Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Eakachai Prompetchara *Center of Excellence in Vaccine Research and Development (Chula VRC), Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Sivaporn GatechompolSchool of Global Health, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Chutitorn KetloyCenter of Excellence in Vaccine Research and Development (Chula VRC), Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Arunee ThitithanyanontDepartment of Microbiology, Faculty of Science, Mahidol University, Bangkok, Thailand.
Anan JongkaewwattanaVirology and Cell Technology Research Team, National Center for Genetic Engineering and Biotechnology (BIOTEC), National Science and Technology Development Agency (NSTDA), Pathum Thani, Thailand.
Supranee BuranapraditkunCenter of Excellence in Vaccine Research and Development (Chula VRC), Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Sasiwimol UbolyamClinical Research Laboratory/HIV-NAT Laboratory, ChulaCRC, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Stephen J KerrBiostatistics Excellence Centre, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Jiratchaya SophonphanBiostatistics Unit, HIVNAT, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.
Tanakorn ApornpongBiostatistics Unit, HIVNAT, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.
Wonngarm KittanamongkolchaiMaha Chakri Sirindhorn Clinical Research Center (ChulaCRC), Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Sarawut SiwamogsathamMaha Chakri Sirindhorn Clinical Research Center (ChulaCRC), Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Somchai SriplienchanSEARCH Research Foundation, Bangkok, Thailand.
Kanitha PatarakulCenter of Excellence in Vaccine Research and Development (Chula VRC), Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Tuangtip TheerawitCenter of Excellent for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Pathariya PromsenaCenter of Excellent for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Rapisa NantaneeDepartment of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Siwaporn ManomaisantiphapDepartment of Pharmacology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Sarun ChokyakornDepartment of Pharmacology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Lina HongGenevant Sciences Corporation, Vancouver, BC, Canada.
Mijo SamijaGenevant Sciences Corporation, Vancouver, BC, Canada.
David C MontefioriDepartment of Surgery, Duke University Medical Center, Durham, NC, USA.
Hongmei GaoDepartment of Surgery, Duke University Medical Center, Durham, NC, USA.
Amanda EatonDepartment of Surgery, Duke University Medical Center, Durham, NC, USA.
Wassana WijagkanalanBioNet Asia, Co. Ltd., Bangkok, Thailand.
Mohamad-Gabriel AlamehPerelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Drew WeissmanPerelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Kiat RuxrungthamCenter of Excellence in Vaccine Research and Development (Chula VRC), Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. kiat.r@chula.ac.th.
ChulaVac001-Phase 2 study team

Funding

National Vaccine Institute (NVI) 2563.1/11The Ratchadapisek Sompoch Endowment Fund (2021), Chulalongkorn University 764002-HE04
6 · The paper itself

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.

Indexed as

COVID-19COVID-19 VaccinesAdolescentAdultAntibodies, NeutralizingAntibodies, ViralDouble-Blind MethodHumansImmunogenicity, VaccineMiddle AgedmRNA VaccinesYoung AdultAntibodies, NeutralizingAntibodies, ViralChulaCov19 vaccineCOVID-19 VaccinesmRNA Vaccines

Identifiers

PMID38287068
PMCPMC10825165

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.