Evidence map›Paper›PMID 29983563›Full record

ArticleInternational journal of nanomedicine2018

Development of a thermostable nanoemulsion adjuvanted vaccine against tuberculosis using a design-of-experiments approach.

Ryan M Kramer, Michelle C Archer, Mark T Orr, Natasha Dubois Cauwelaert, Elyse A Beebe, Po-Wei D Huang, Quinton M Dowling, Alicia M Schwartz, Dawn M Fedor, Thomas S Vedvick and 1 more

Open access · goldAbstract read
In one paragraph

Article in International journal of nanomedicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
1.8field-weighted citation impact, top 15% 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

23 citing papers in PubMed, 42 citations in OpenAlex.

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  14. Microparticle encapsulation of a tuberculosis subunit vaccine candidate containing a nanoemulsion adjuvant via spray drying.European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V · 2021
    Article
  15. Development of thermostable vaccine adjuvants.Expert review of vaccines · 2021
    Review
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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

11 authors at 1 institution in 1 country.

Ryan M KramerInfectious Disease Research Institute, Seattle, WA, USA, ryan.kramer@idri.org.
Michelle C ArcherInfectious Disease Research Institute, Seattle, WA, USA, ryan.kramer@idri.org.
Mark T OrrInfectious Disease Research Institute, Seattle, WA, USA, ryan.kramer@idri.org.
Natasha Dubois CauwelaertInfectious Disease Research Institute, Seattle, WA, USA, ryan.kramer@idri.org.
Elyse A BeebeInfectious Disease Research Institute, Seattle, WA, USA, ryan.kramer@idri.org.
Po-Wei D HuangInfectious Disease Research Institute, Seattle, WA, USA, ryan.kramer@idri.org.
Quinton M DowlingInfectious Disease Research Institute, Seattle, WA, USA, ryan.kramer@idri.org.
Alicia M SchwartzInfectious Disease Research Institute, Seattle, WA, USA, ryan.kramer@idri.org.
Dawn M FedorInfectious Disease Research Institute, Seattle, WA, USA, ryan.kramer@idri.org.
Thomas S VedvickInfectious Disease Research Institute, Seattle, WA, USA, ryan.kramer@idri.org.
Christopher B FoxInfectious Disease Research Institute, Seattle, WA, USA, ryan.kramer@idri.org.
Infectious Disease Research Institute · US

Funding

NIAID NIH HHS HHSN272201400041C
6 · The paper itself

Abstract

backgroundAdjuvants have the potential to increase the efficacy of protein-based vaccines but need to be maintained within specific temperature and storage conditions. Lyophilization can be used to increase the thermostability of protein pharmaceuticals; however, no marketed vaccine that contains an adjuvant is currently lyophilized, and lyophilization of oil-in-water nanoemulsion adjuvants presents a specific challenge. We have previously demonstrated the feasibility of lyophilizing a candidate adjuvanted protein vaccine against MATERIALS AND

methodsIn this study, we took a systematic approach to the development of a thermostable product by first identifying compatible solution conditions and stabilizing excipients for both antigen and adjuvant. Next, we applied a design-of-experiments approach to identify stable lyophilized drug product formulations.

resultsWe identified specific formulations that contain disaccharide or a combination of disaccharide and mannitol that can achieve substantially improved thermostability and maintain immunogenicity in a mouse model when tested in accelerated and real-time stability studies.

conclusionThese efforts will aid in the development of a platform formulation for use with other similar vaccines.

Indexed as

TemperatureAdjuvants, ImmunologicAnimalsAntibody FormationChemistry, PharmaceuticalDynamic Light ScatteringEmulsionsExcipientsFemaleFreeze DryingHydrogen-Ion ConcentrationImmunity, CellularLipidsMice, Inbred C57BLMycobacterium tuberculosisNanoparticlesAdjuvants, ImmunologicEmulsionsExcipientsLipidsTuberculosis Vaccinesadjuvantcontrolled temperature chaindesign of experimentsformulation developmentGRASlyophilizationtuberculosis

Identifiers

PMID29983563
PMCPMC6028350
OpenAlexW2810532210

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.