Evidence map›Paper›PMID 26926241›Full record

ArticleDrug delivery and translational research2017

Long-term stability of influenza vaccine in a dissolving microneedle patch.

Matthew J Mistilis, Jessica C Joyce, E Stein Esser, Ioanna Skountzou, Richard W Compans, Andreas S Bommarius, Mark R Prausnitz

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

Article in Drug delivery and translational research, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 61 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
61citing papers in PubMed, 1 pooled it
6.4field-weighted citation impact, top 3% 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

61 citing papers in PubMed, 1 synthesis or guideline pooled it, 144 citations in OpenAlex.

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1 more citing papers are in PubMed but not listed here.

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

7 authors at 3 institutions in 1 country.

Matthew J MistilisSchool of Chemical and Biomolecular Engineering, Georgia Institute of Technology, 311 Ferst Drive, Atlanta, GA, 30332-0100, USA.
Jessica C JoyceWallace H. Coulter Department of Biomedical Engineering, Georgia Tech and Emory University, Georgia Institute of Technology, 313 Ferst Drive, Atlanta, GA, 30332-0100, USA.
E Stein EsserDepartment of Microbiology and Immunology and Emory Vaccine Center, Emory University School of Medicine, 1518 Clifton Road, Atlanta, GA, 30322, USA.
Ioanna SkountzouDepartment of Microbiology and Immunology and Emory Vaccine Center, Emory University School of Medicine, 1518 Clifton Road, Atlanta, GA, 30322, USA.
Richard W CompansDepartment of Microbiology and Immunology and Emory Vaccine Center, Emory University School of Medicine, 1518 Clifton Road, Atlanta, GA, 30322, USA.
Andreas S BommariusSchool of Chemical and Biomolecular Engineering, Georgia Institute of Technology, 311 Ferst Drive, Atlanta, GA, 30332-0100, USA.
Mark R PrausnitzSchool of Chemical and Biomolecular Engineering, Georgia Institute of Technology, 311 Ferst Drive, Atlanta, GA, 30332-0100, USA. prausnitz@gatech.edu.
Emory University · USGeorgia Institute of Technology · USThe Wallace H. Coulter Department of Biomedical Engineering · US

Funding

Influenza vaccination using a microneedle patchU01EB012495 · NIBIB · GEORGIA INSTITUTE OF TECHNOLOGY · PI PRAUSNITZ, MARK R. · 2010 to 2015
$9.6M
Research Training Program Plan on Cell and Tissue Engineering (CTEng)T32GM008433 · NIGMS · GEORGIA INSTITUTE OF TECHNOLOGY · PI GARCIA, ANDRES J · 1991 to 2021
$7.1M
NIBIB NIH HHS U01 EB012495NIGMS NIH HHS T32 GM008433
6 · The paper itself

Abstract

This study tested the hypothesis that optimized microneedle patch formulations can stabilize trivalent subunit influenza vaccine during long-term storage outside the cold chain and when exposed to potential stresses found during manufacturing and storage. Formulations containing combinations of trehalose/sucrose, sucrose/arginine, and arginine/heptagluconate were successful at retaining most or all vaccine activity during storage at 25 °C for up to 24 months as determined by ELISA assay. The best formulation of microneedle patches contained arginine/heptagluconate, which showed no significant loss of vaccine activity during the study. To validate these in vitro findings, mice were immunized using trivalent influenza vaccine stored in microneedle patches for more than 1 year at 25 °C, which elicited antibody titers greater than or equal to fresh liquid vaccine delivered by intradermal injection, indicating the retention of immunogenicity during storage. Finally, influenza vaccine in microneedle patches lost no significant activity during exposure to 60 °C for 4 months, multiple freeze-thaw cycles, or electron beam irradiation. We conclude that optimally formulated microneedle patches can retain influenza vaccine activity during extended storage outside the cold chain and during other environmental stresses, which suggests the possibility of microneedle patch storage on pharmacy shelves without refrigeration.

Indexed as

MicroinjectionsNeedlesTransdermal PatchAdministration, CutaneousAnimalsDrug StabilityFemaleHemagglutininsInfluenza A Virus, H1N1 SubtypeInfluenza VaccinesMice, Inbred BALB CTemperatureHemagglutininsInfluenza VaccinesInfluenza vaccineMicroneedleSolid dosage formTransdermal deliveryVaccine deliveryVaccine formulationVaccine stability

Identifiers

PMID26926241
PMCPMC5003766
OpenAlexW2288585821

What OpenQuestion holds

Textmetadata
LicenceTDM
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.