Evidence map›Paper›PMID 33278492›Full record

ArticleInternational journal of pharmaceutics2021

Development of a formulation platform for a spray-dried, inhalable tuberculosis vaccine candidate.

Mellissa Gomez, Joseph McCollum, Hui Wang, Mani Ordoubadi, Chester Jar, Nicholas B Carrigy, David Barona, Isobel Tetreau, Michelle Archer, Alana Gerhardt and 4 more

Abstract read
In one paragraph

Article in International journal of pharmaceutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing 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

21 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Characterization of Spray-Dried Powders Using a Coated Alberta Idealized Nasal Inlet.Journal of aerosol medicine and pulmonary drug delivery · 2025
    Article
  6. Review
  7. Article
  8. Review
  9. Review
  10. Nanotechnology of inhalable vaccines for enhancing mucosal immunity.Drug delivery and translational research · 2024
    Review
  11. MedComm · 2024
    Review
  12. Review
  13. Neutralisation of SARS-CoV-2 by monoclonal antibody through dual targeting powder formulation.Journal of controlled release : official journal of the Controlled Release Society · 2023
    Article
  14. Article
  15. Article
  16. Review
  17. Article
  18. 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
  19. Development of thermostable vaccine adjuvants.Expert review of vaccines · 2021
    Review
  20. The Research Progress in Immunotherapy of Tuberculosis.Frontiers in cellular and infection microbiology · 2021
    Review
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

14 authors.

Mellissa GomezDepartment of Mechanical Engineering, University of Alberta, Edmonton, AB, Canada.
Joseph McCollumInfectious Disease Research Institute, Seattle, WA, USA.
Hui WangDepartment of Mechanical Engineering, University of Alberta, Edmonton, AB, Canada.
Mani OrdoubadiDepartment of Mechanical Engineering, University of Alberta, Edmonton, AB, Canada.
Chester JarDepartment of Mechanical Engineering, University of Alberta, Edmonton, AB, Canada.
Nicholas B CarrigyDepartment of Mechanical Engineering, University of Alberta, Edmonton, AB, Canada.
David BaronaDepartment of Mechanical Engineering, University of Alberta, Edmonton, AB, Canada.
Isobel TetreauDepartment of Mechanical Engineering, University of Alberta, Edmonton, AB, Canada.
Michelle ArcherInfectious Disease Research Institute, Seattle, WA, USA.
Alana GerhardtInfectious Disease Research Institute, Seattle, WA, USA.
Chris PressInfectious Disease Research Institute, Seattle, WA, USA.
Christopher B FoxInfectious Disease Research Institute, Seattle, WA, USA; Department of Global Health, University of Washington, Seattle, WA, USA.
Ryan M KramerInfectious Disease Research Institute, Seattle, WA, USA.
Reinhard VehringDepartment of Mechanical Engineering, University of Alberta, Edmonton, AB, Canada. Electronic address: reinhard.vehring@ualberta.ca.

Funding

NIAID NIH HHS HHSN272201400041C
6 · The paper itself

Abstract

Protection against primarily respiratory infectious diseases, such as tuberculosis (TB), can likely be enhanced through mucosal immunization induced by direct delivery of vaccines to the nose or lungs. A thermostable inhalable dry powder vaccine offers further advantages, such as independence from the cold chain. In this study, we investigate the formulation for a stable, inhalable dry powder version of ID93 + GLA-SE, an adjuvanted subunit TB vaccine candidate, containing recombinant fusion protein ID93 and glucopyranosyl lipid A (GLA) in a squalene emulsion (SE) as an adjuvant system, via spray drying. The addition of leucine (20% w/w), pullulan (10%, 20% w/w), and trileucine (3%, 6% w/w) as dispersibility enhancers was investigated with trehalose as a stabilizing agent. Particle morphology and solid state, nanoemulsion droplet size, squalene and GLA content, ID93 presence, and aerosol performance were assessed for each formulation. The results showed that the addition of leucine improved aerosol performance, but increased aggregation of the emulsion droplets was demonstrated on reconstitution. Addition of pullulan preserved emulsion droplet size; however, the antigen could not be detected after reconstitution. The trehalose-trileucine excipient formulations successfully stabilized the adjuvant system, with evidence indicating retention of the antigen, in an inhalable dry powder format suitable for lung delivery.

Indexed as

TuberculosisTuberculosis VaccinesAdjuvants, ImmunologicAdministration, InhalationAerosolsExcipientsHumansParticle SizePowdersAdjuvants, ImmunologicAerosolsExcipientsPowdersTuberculosis VaccinesDispersibilityInhalable deliveryNanoencapsulationParticle engineeringSpray dryingTuberculosis vaccine

Identifiers

PMID33278492
PMCPMC7790949

What OpenQuestion holds

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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.