Evidence map›Paper›PMID 40594764›Full record

ArticleScientific reports2025

Efficacy and safety of a novel multivalent mRNA vaccine against SARS-CoV-2 in experimental animals.

Seung Eui Min, Eun-Young Gu, Min Seong Jang, Young-Ju Lee, Ji-Seok Han, Woo Ghil Lee, Seong In Jeong, Ji Young Song, In-Chul Lee, Hyung-Jun Kwon and 5 more

Abstract read
In one paragraph

Article in Scientific reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
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

15 authors.

Seung Eui MinHuman and Environmental Toxicology, University of Science and Technology, 217 Gajeong-ro, Yuseong-gu, Daejeon, 34113, Republic of Korea.
Eun-Young GuDepartment of Advanced Toxicology Research, Korea Institute of Toxicology, 141 Gaejeongro, Yuseong-gu, Daejeon, 34114, Republic of Korea.
Min Seong JangDepartment of Advanced Toxicology Research, Korea Institute of Toxicology, 141 Gaejeongro, Yuseong-gu, Daejeon, 34114, Republic of Korea.
Young-Ju LeeDepartment of Advanced Toxicology Research, Korea Institute of Toxicology, 141 Gaejeongro, Yuseong-gu, Daejeon, 34114, Republic of Korea.
Ji-Seok HanDepartment of Advanced Toxicology Research, Korea Institute of Toxicology, 141 Gaejeongro, Yuseong-gu, Daejeon, 34114, Republic of Korea.
Woo Ghil LeeRnagene Co., Ltd., 603-605, 7 Beobwon-ro 6-gil, Songpa-gu, Seoul-si, 05855, Republic of Korea.
Seong In JeongRnagene Co., Ltd., 603-605, 7 Beobwon-ro 6-gil, Songpa-gu, Seoul-si, 05855, Republic of Korea.
Ji Young SongRnagene Co., Ltd., 603-605, 7 Beobwon-ro 6-gil, Songpa-gu, Seoul-si, 05855, Republic of Korea.
In-Chul LeeKorea Research Institute of Bioscience and Biotechnology, Functional Biomaterial Research Center, 181 Ipsin-gil, Jeongeup-si, Republic of Korea.
Hyung-Jun KwonKorea Research Institute of Bioscience and Biotechnology, Functional Biomaterial Research Center, 181 Ipsin-gil, Jeongeup-si, Republic of Korea.
Young-Bae RyuKorea Research Institute of Bioscience and Biotechnology, Functional Biomaterial Research Center, 181 Ipsin-gil, Jeongeup-si, Republic of Korea.
Kyong-Cheol KoKorea Research Institute of Bioscience and Biotechnology, Korea Preclinical Evaluation Center, 125 Gwahak-ro, Yuseong-gu, Daejeon, 34141, South Korea.
Byung Sun MinCollege of Pharmacy, Daegu Catholic University, Gyeongsan, Gyeongbuk, 38430, Republic of Korea.
Yong-Bum KimDepartment of Advanced Toxicology Research, Korea Institute of Toxicology, 141 Gaejeongro, Yuseong-gu, Daejeon, 34114, Republic of Korea. ybkim@kitox.re.kr.
Kang-Hyun HanHuman and Environmental Toxicology, University of Science and Technology, 217 Gajeong-ro, Yuseong-gu, Daejeon, 34113, Republic of Korea. hankh@kitox.re.kr.

Funding

Bio & Medical Technology Development Program of the National Research Foundation (NRF) & funded by the Korean government (MSIT) 2022M3A9J1072296Korea Institute of Toxicology 2710008772
6 · The paper itself

Abstract

The mRNA vaccine is an innovative new platform that can be developed rapidly, offering a robust tool to managing infectious diseases like COVID-19. However, non-clinical evaluations are essential for safety use. In this study, the efficacy, general toxicity, and safety pharmacology of a novel multivalent mRNA-encapsulated lipid nanoparticle (LNP) vaccine (RGV-DO-003) were evaluated using a focus reduction neutralization test (FRNT), virus challenge test, single- and repeated-dose studies, immunogenicity tests, and neurobehavioral, body temperature, respiratory, and cardiovascular system assessments in experimental animals. The administration route was intramuscular, and the vaccine doses were 5 and 50 μg/head for each efficacy test and toxicity study. Neutralizing antibodies were observed in the vaccinated group through FRNT and virus challenge tests. Macroscopic observations revealed a tendency for the lung lesion area to decrease in the vaccinated group. In the general toxicity study, mild symptoms were observed at the injection site in the vaccine administration group. Immunogenicity analysis revealed an increase in the binding antibody titer in the vaccine-administered group. Safety pharmacology study revealed no significant toxicological changes associated with LNP or vaccine administration. Overall, the RGV-DO-003 mRNA vaccine is effective and safe under experimental conditions, suggesting it is a potential candidate for clinical trials.

Indexed as

COVID-19COVID-19 VaccinesRNA, MessengerSARS-CoV-2AnimalsAntibodies, NeutralizingAntibodies, ViralFemaleLiposomesMaleMicemRNA VaccinesNanoparticlesVaccine EfficacyVaccines, SyntheticAntibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesLipid NanoparticlesLiposomesmRNA VaccinesRNA, MessengerVaccines, SyntheticAdverse effectImmunogenicityIn vivo GLP Toxicity studymRNA vaccineSARS-CoV-2Virus challenge test

Identifiers

PMID40594764
PMCPMC12217173

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.