Evidence map›Paper›PMID 23583494›Full record

ArticleEuropean journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V2013

Stabilization of a recombinant ricin toxin A subunit vaccine through lyophilization.

Kimberly J Hassett, Megan C Cousins, Lilia A Rabia, Chrystal M Chadwick, Joanne M O'Hara, Pradyot Nandi, Robert N Brey, Nicholas J Mantis, John F Carpenter, Theodore W Randolph

Abstract read
In one paragraph

Article in European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing 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

24 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Review
  6. Article
  7. An Experimental Adult Zebrafish Model forMicrobiology spectrum · 2022
    Article
  8. Review
  9. Article
  10. Article
  11. Development of thermostable vaccine adjuvants.Expert review of vaccines · 2021
    Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Thermostable Ebola virus vaccine formulations lyophilized in the presence of aluminum hydroxide.European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V · 2019
    Article
  17. Article
  18. Article
  19. Review
  20. Recent advances in the development of vaccines against ricin.Human vaccines & immunotherapeutics · 2016
    Article
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

10 authors.

Kimberly J HassettDepartment of Chemical and Biological Engineering, University of Colorado, Boulder, USA.
Megan C Cousins
Lilia A Rabia
Chrystal M Chadwick
Joanne M O'Hara
Pradyot Nandi
Robert N Brey
Nicholas J Mantis
John F Carpenter
Theodore W Randolph

Funding

Development of stable and rapidly acting adjuvanted vaccines for biodefenseU01AI082210 · NIAID · SOLIGENIX, INC. · PI BREY, ROBERT N. · 2009 to 2013
$9.1M
Predoctoral Training Molecular BiophysicsT32GM065103 · NIGMS · UNIVERSITY OF COLORADO AT BOULDER · PI FALKE, JOSEPH J · 2002 to 2021
$4.3M
LEADERSHIP TRAINING IN PHARMACEUTICAL BIOTECHNOLOGYT32GM008732 · NIGMS · UNIVERSITY OF COLORADO AT BOULDER · PI RANDOLPH, THEODORE W · 2001 to 2015
$2.7M
NIAID NIH HHS U01 AI082210NIGMS NIH HHS T32 GM008732NIGMS NIH HHS T32 GM-065103NIGMS NIH HHS T32 GM065103PHS HHS U01-A1-08-2210
6 · The paper itself

Abstract

Lyophilization was used to prepare dry, glassy solid vaccine formulations of recombinant ricin toxin A-chain containing suspensions of colloidal aluminum hydroxide adjuvant. Four lyophilized formulations were prepared by using combinations of rapid or slow cooling during lyophilization and one of two buffers, histidine or ammonium acetate. Trehalose was used as the stabilizing excipient. Aggregation of the colloidal aluminum hydroxide suspension was reduced in formulations processed with a rapid cooling rate. Aluminum hydroxide particle size distributions, glass transition temperatures, water contents, and immunogenicities of lyophilized vaccines were independent of incubation time at 40 °C for up to 15 weeks. Mice immunized with reconstituted ricin toxin subunit A (RTA) vaccines produced RTA-specific antibodies and toxin-neutralizing antibodies (TNAs) regardless of the length of high temperature vaccine storage or the degree of aluminum adjuvant aggregation that occurred during lyophilization. In murine studies, lyophilized formulations of vaccines conferred protection against exposure to lethal doses of ricin, even after the lyophilized formulations had been stored at 40 °C for 4 weeks. A corresponding liquid formulation of vaccine stored at 40 °C elicited RTA-specific antibody titers but failed to confer immunity during a ricin challenge.

Indexed as

Drug StabilityAdjuvants, ImmunologicAdjuvants, PharmaceuticAluminum HydroxideAnimalsAntibodies, NeutralizingAntibody FormationBuffersChemistry, PharmaceuticalDrug StorageExcipientsFemaleFreeze DryingHot TemperatureMiceParticle SizeAdjuvants, ImmunologicAdjuvants, PharmaceuticAluminum HydroxideAntibodies, NeutralizingBuffersExcipientsRecombinant ProteinsRicinTrehaloseVaccines, SubunitWaterAdjuvantAggregationAluminumBiodefenseFreeze dryingLyophilizationRicinStabilityVaccine

Identifiers

PMID23583494
PMCPMC3797224

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.