Evidence map›Paper›PMID 40968316›Full record

ArticlePharmaceutical research2025

Formulation, Characterization, and In Vivo Immunogenicity of Heat-Stabilized Dissolvable Microneedles Containing a Novel VLP Vaccine.

Aidan Leyba, Alexandra Francian, Mohammad Razjmoo, Amelia Bierle, Ranjith Janardhana, Nathan Jackson, Bryce Chackerian, Pavan Muttil

Abstract read
In one paragraph

Article in Pharmaceutical research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
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  3. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors.

Aidan Leyba *Department of Pharmaceutical Sciences, College of Pharmacy, University of New Mexico Health Sciences Center, Albuquerque, NM, 87131, USA.
Alexandra Francian *Department of Molecular Genetics and Microbiology, School of Medicine, University of New Mexico Health Sciences Center, Albuquerque, NM, 87131, USA.
Mohammad RazjmooDepartment of Pharmaceutical Sciences, College of Pharmacy, University of New Mexico Health Sciences Center, Albuquerque, NM, 87131, USA.
Amelia BierleDepartment of Pharmaceutical Sciences, College of Pharmacy, University of New Mexico Health Sciences Center, Albuquerque, NM, 87131, USA.
Ranjith JanardhanaDepartment of Mechanical Engineering, University of New Mexico, Albuquerque, NM, 87131, USA.
Nathan JacksonDepartment of Mechanical Engineering, University of New Mexico, Albuquerque, NM, 87131, USA.
Bryce ChackerianDepartment of Molecular Genetics and Microbiology, School of Medicine, University of New Mexico Health Sciences Center, Albuquerque, NM, 87131, USA.
Pavan MuttilDepartment of Pharmaceutical Sciences, College of Pharmacy, University of New Mexico Health Sciences Center, Albuquerque, NM, 87131, USA. pmuttil@salud.unm.edu.ORCID http://orcid.org/0000-0001-7636-8141

Funding

Unfolded Protein Response and Autophagy in T Helper Cell Effector FunctionP20GM121176 · NIGMS · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · PI Judy Lin Cannon · 2017 to 2026
$24.9M
Strategies for targeting T follicular helper cells to improve HIV Env vaccine immunogenicity and efficacyP01AI181044 · NIAID · UNIVERSITY OF CALIFORNIA AT DAVIS · PI DENNIS J. HARTIGAN-O'CONNOR · 2025 to 2026
$11.0M
Virus-like Particle based malaria vaccines targeting vulnerable epitopes in the circumsporozoite proteinR01AI169739 · NIAID · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · PI Bryce C Chackerian · 2023 to 2026
$2.5M
NIAID NIH HHS P01 AI181044NIAID NIH HHS R01 AI169739NIDDK NIH HHS R01 AI169739NIGMS NIH HHS P20 GM121176
6 · The paper itself

Abstract

objectiveVaccination has significantly improved health outcomes, but implementing vaccination efforts in low and middle-income countries, particularly in warmer climates, presents challenges. Microneedle technology has been developed for its simple and relatively painless applications of vaccines. However, a few hurdles must be overcome before widespread acceptance, including evaluating the safety and biocompatibility of the polymer used to fabricate these microneedles. Additionally, it is important to demonstrate reliable immune responses comparable to or better than those achieved through traditional administration routes. This study aimed to develop and evaluate dissolvable microneedles loaded with a novel virus-like particle (VLP) vaccine, focusing on their fabrication, characterization, thermostability, and preclinical immunogenicity.

methodsMicroneedles were fabricated using the micro-molding technique with polyacrylic acid (PAA) polymer, incorporating a novel VLP vaccine targeting arbovirus. Characterization studies assessed microneedle sharpness, skin insertion force, and VLP integrity. We also investigated the thermostability of the vaccine after storing the microneedles at elevated temperatures for approximately 140 days. Vaccine immunogenicity was assessed in mice, and transdermal (microneedle) delivery was compared with intramuscular (hypodermic needle) delivery.

resultsThe study successfully fabricated and characterized VLP-loaded microneedles capable of skin insertion while maintaining vaccine integrity after exposure to extreme storage conditions. These microneedles elicited robust and long-lasting antibody responses comparable to those achieved through intramuscular administration.

conclusionsThis study combines a novel VLP-based vaccine with dissolvable MNs fabricated under pH-neutral conditions, preserving antigen integrity and immunogenicity after high-temperature storage. This vaccine delivery platform addresses critical gaps in thermostability and needle-free vaccine delivery for resource-limited settings.

Indexed as

Immunogenicity, VaccineNeedlesVaccines, Virus-Like ParticleAcrylic ResinsAdministration, CutaneousAnimalsAntibodies, ViralDrug Delivery SystemsDrug StabilityFemaleHot TemperatureInjections, IntramuscularMiceMice, Inbred BALB CMicroinjectionsVaccinationAcrylic ResinsAntibodies, Viralcarbopol 940Vaccines, Virus-Like Particlecold-chainmicroneedlesthermostablevaccinationvirus-like particle

Identifiers

PMID40968316
PMCPMC12667035

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Registered trials

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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.