Evidence map›Paper›PMID 39852865›Full record

ArticleVaccines2025

The Long-Term Immunity of a Microneedle Array Patch of a SARS-CoV-2 S1 Protein Subunit Vaccine Irradiated by Gamma Rays in Mice.

Eun Kim, Muhammad S Khan, Juyeop Shin, Shaohua Huang, Alessandro Ferrari, Donghoon Han, Eunjin An, Thomas W Kenniston, Irene Cassaniti, Fausto Baldanti and 2 more

Abstract read
In one paragraph

Article in Vaccines, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors.

Eun KimDepartment of Surgery, University of Pittsburgh School of Medicine, Pittsburgh, PA 15213, USA.ORCID 0000-0001-7963-7722
Muhammad S KhanDepartment of Surgery, University of Pittsburgh School of Medicine, Pittsburgh, PA 15213, USA.
Juyeop ShinMedical Business Division, Raphas Co., Ltd., Seoul 07793, Republic of Korea.
Shaohua HuangDepartment of Surgery, University of Pittsburgh School of Medicine, Pittsburgh, PA 15213, USA.
Alessandro FerrariMolecular Virology Unit, Microbiology and Virology Department, IRCCS Policlinico San Matteo, 27100 Pavia, Italy.
Donghoon HanMedical Business Division, Raphas Co., Ltd., Seoul 07793, Republic of Korea.
Eunjin AnMedical Business Division, Raphas Co., Ltd., Seoul 07793, Republic of Korea.
Thomas W KennistonDepartment of Surgery, University of Pittsburgh School of Medicine, Pittsburgh, PA 15213, USA.
Irene CassanitiMolecular Virology Unit, Microbiology and Virology Department, IRCCS Policlinico San Matteo, 27100 Pavia, Italy.ORCID 0000-0002-3385-2088
Fausto BaldantiMolecular Virology Unit, Microbiology and Virology Department, IRCCS Policlinico San Matteo, 27100 Pavia, Italy.
Dohyeon JeongMedical Business Division, Raphas Co., Ltd., Seoul 07793, Republic of Korea.ORCID 0000-0002-1856-2998
Andrea GambottoDepartment of Surgery, University of Pittsburgh School of Medicine, Pittsburgh, PA 15213, USA.

Funding

Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
New Strategy to Improve Gastrointestinal Health in SIV/HIVR01DK119936 · NIDDK · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI APETREI, CRISTIAN · 2018 to 2022
$5.1M
U01 Proposal Transfer - 2021U01CA233085 · NCI · UNIVERSITY OF CHICAGO · PI GAMBOTTO, ANDREA, KOZBOR, DANUTA B · 2019 to 2019
$4.1M
GAPHAS PHARMACEUTICAL INC AWD00008437National Institutes of Health grants UM1-AI106701, R01DK119936-S1, and U01-CA233085NCI NIH HHS U01 CA233085NIAID NIH HHS UM1 AI106701NIDDK NIH HHS R01 DK119936
6 · The paper itself

Abstract

BACKGROUND/

objectivesCOVID-19 vaccines effectively prevent severe disease, but unequal distribution, especially in low- and middle-income countries, has led to vaccine-resistant strains. This highlights the urgent need for alternative vaccine platforms that are safe, thermostable, and easy to distribute. This study evaluates the immunogenicity, stability, and scalability of a dissolved microneedle array patch (MAP) delivering the rS1RS09 subunit vaccine, comprising the SARS-CoV-2 S1 monomer and RS09, a TLR-4 agonist peptide.

methodsThe rS1RS09 vaccine was administered via MAP or intramuscular injection in murine models. The immune responses of the MAP with and without gamma irradiation as terminal sterilization were assessed at doses of 5, 15, and 45 µg, alongside neutralizing antibody responses to Wuhan, Delta, and Omicron variants. The long-term storage stability was also evaluated through protein degradation analyses at varying temperatures.

resultsThe rS1RS09 vaccine elicited stronger immune responses and ACE2-binding inhibition than S1 monomer alone or trimer. The MAP delivery induced sgnificantly higher and longer-lasting S1-specific IgG responses for up to 70 weeks compared to intramuscular injections. Robust Th2-prevalent immune responses were generated in all the groups vaccinated via the MAP and significant neutralizing antibodies were elicited at 15 and 45 µg, showing dose-sparing potential. The rS1RS09 in MAP has remained stable with minimal protein degradation for 19 months at room temperature or under refrigeration, regardless of gamma-irradiation. After an additional month of storage at 42 °C, cit showed less than 3% degradation, ompared to over 23% in liquid vaccines Conclusions: Gamma-irradiated MAP-rS1RS09 is a promising platform for stable, scalable vaccine production and distribution, eliminating cold chain logistics. These findings support its potential for mass vaccination efforts, particularly in resource-limited settings.

Indexed as

COVID-19 vaccinegamma irradiation sterilizationmicroneedle array patchS1 protein subunitSARS-CoV-2thermostability

Identifiers

PMID39852865
PMCPMC11768753

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.