Evidence map›Paper›PMID 38140172›Full record

ArticleVaccines2023

A Phase I/II Clinical Trial of Intradermal, Controllable Self-Replicating Ribonucleic Acid Vaccine EXG-5003 against SARS-CoV-2.

Takenao Koseki, Mayumi Teramachi, Minako Koga, Minoru S H Ko, Tomokazu Amano, Hong Yu, Misa Amano, Erica Leyder, Maria Badiola, Priyanka Ray and 11 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Vaccines, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.4field-weighted citation impact, top 19% of its field
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

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Immunology of RNA-based vaccines: The critical interplay between inflammation and expression.Molecular therapy : the journal of the American Society of Gene Therapy · 2025
    Review
  2. Review
  3. Review
  4. International journal of molecular sciences · 2024
    Article
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

21 authors at 3 institutions in 2 countries.

Takenao KosekiDepartment of Pharmacotherapeutics and Informatics, School of Medicine, Fujita Health University, Toyoake 470-1192, Japan.ORCID 0000-0002-2889-9586
Mayumi TeramachiCenter for Clinical Trial and Research Support, School of Medicine, Fujita Health University, Toyoake 470-1192, Japan.
Minako KogaKM Pharmaceutical Consulting, Washington, DC 20006, USA.
Minoru S H KoElixirgen Therapeutics, Inc., Baltimore, MD 21205, USA.ORCID 0000-0002-3530-3015
Tomokazu AmanoElixirgen Therapeutics, Inc., Baltimore, MD 21205, USA.
Hong YuElixirgen Therapeutics, Inc., Baltimore, MD 21205, USA.
Misa AmanoElixirgen Therapeutics, Inc., Baltimore, MD 21205, USA.
Erica LeyderElixirgen Therapeutics, Inc., Baltimore, MD 21205, USA.
Maria BadiolaElixirgen Therapeutics, Inc., Baltimore, MD 21205, USA.
Priyanka RayElixirgen Therapeutics, Inc., Baltimore, MD 21205, USA.
Jiyoung KimElixirgen Therapeutics, Inc., Baltimore, MD 21205, USA.
Akihiro C KoElixirgen Therapeutics, Inc., Baltimore, MD 21205, USA.
Achouak AchourLaboratory of Molecular Biology and Immunology, National Institute on Aging, National Institutes of Health, Baltimore, MD 20892, USA.
Nan-Ping WengLaboratory of Molecular Biology and Immunology, National Institute on Aging, National Institutes of Health, Baltimore, MD 20892, USA.
Takumi ImaiDepartment of Medical Statistics, Graduate School of Medicine, Osaka Metropolitan University, Osaka 545-8585, Japan.ORCID 0000-0002-0541-3467
Hisako YoshidaDepartment of Medical Statistics, Graduate School of Medicine, Osaka Metropolitan University, Osaka 545-8585, Japan.
Satsuki TaniuchiDepartment of Medical Statistics, Graduate School of Medicine, Osaka Metropolitan University, Osaka 545-8585, Japan.ORCID 0000-0003-1135-3218
Ayumi ShintaniDepartment of Medical Statistics, Graduate School of Medicine, Osaka Metropolitan University, Osaka 545-8585, Japan.
Hidetsugu FujigakiDepartment of Advanced Diagnostic System Development, Graduate School of Health Sciences, Fujita Health University, Toyoake 470-1192, Japan.
Masashi KondoCenter for Clinical Trial and Research Support, School of Medicine, Fujita Health University, Toyoake 470-1192, Japan.
Yohei DoiDepartments of Microbiology and Infectious Diseases, School of Medicine, Fujita Health University, Toyoake 470-1192, Japan.ORCID 0000-0002-9620-2525
Fujita Health University · JPOsaka Metropolitan University · JPNational Institutes of Health · US

Funding

Japan Agency for Medical Research and Development JP21nf0101631
6 · The paper itself

Abstract

mRNA vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have played a key role in reducing morbidity and mortality from coronavirus disease 2019 (COVID-19). We conducted a double-blind, placebo-controlled phase I/II trial to evaluate the safety, tolerability, and immunogenicity of EXG-5003, a two-dose, controllable self-replicating RNA vaccine against SARS-CoV-2. EXG-5003 encodes the receptor binding domain (RBD) of SARS-CoV-2 and was administered intradermally without lipid nanoparticles (LNPs). The participants were followed for 12 months. Forty healthy participants were enrolled in Cohort 1 (5 µg per dose,

Indexed as

COVID-19immunogenicitymessenger RNAreceptor-binding domainsafetyself-amplifying RNAself-replicating RNA

Identifiers

PMID38140172
PMCPMC10747308
OpenAlexW4389044624

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.