Evidence map›Paper›PMID 25581103›Full record

ArticleJournal of pharmaceutical sciences2015

Glassy-state stabilization of a dominant negative inhibitor anthrax vaccine containing aluminum hydroxide and glycopyranoside lipid A adjuvants.

Kimberly J Hassett, David J Vance, Nishant K Jain, Neha Sahni, Lilia A Rabia, Megan C Cousins, Sangeeta Joshi, David B Volkin, C Russell Middaugh, Nicholas J Mantis and 2 more

Open access · bronzeAbstract read
In one paragraph

Article in Journal of pharmaceutical sciences, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
1.2field-weighted citation impact, top 21% 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

16 citing papers in PubMed, 31 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Review
  6. Review
  7. Article
  8. Development of thermostable vaccine adjuvants.Expert review of vaccines · 2021
    Review
  9. Article
  10. Article
  11. Article
  12. 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
  13. Review
  14. Article
  15. Review
  16. Development of a highly thermostable, adjuvanted human papillomavirus vaccine.European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V · 2015
    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

12 authors at 5 institutions in 2 countries.

Kimberly J HassettDepartment of Chemical and Biological Engineering, Center for Pharmaceutical Biotechnology, University of Colorado, Boulder, Boulder, Colorado, 80303.
David J Vance
Nishant K Jain
Neha Sahni
Lilia A Rabia
Megan C Cousins
Sangeeta Joshi
David B Volkin
C Russell Middaugh
Nicholas J Mantis
John F Carpenter
Theodore W Randolph
University of Kansas · USUniversity of Colorado Boulder · USNew York State Department of Health · USUniversity at Albany, State University of New York · USUniversity of Colorado Denver · US

Funding

Development of stable and rapidly acting adjuvanted vaccines for biodefenseU01AI082210 · NIAID · SOLIGENIX, INC. · PI BREY, ROBERT N. · 2009 to 2013
$9.1M
NIAID NIH HHS U01 AI082210PHS HHS U01-A1-08-2210
6 · The paper itself

Abstract

During transport and storage, vaccines may be exposed to temperatures outside of the range recommended for storage, potentially causing efficacy losses. To better understand and prevent such losses, dominant negative inhibitor (DNI), a recombinant protein antigen for a candidate vaccine against anthrax, was formulated as a liquid and as a glassy lyophilized powder with the adjuvants aluminum hydroxide and glycopyranoside lipid A (GLA). Freeze-thawing of the liquid vaccine caused the adjuvants to aggregate and decreased its immunogenicity in mice. Immunogenicity of liquid vaccines also decreased when stored at 40°C for 8 weeks, as measured by decreases in neutralizing antibody titers in vaccinated mice. Concomitant with efficacy losses at elevated temperatures, changes in DNI structure were detected by fluorescence spectroscopy and increased deamidation was observed by capillary isoelectric focusing (cIEF) after only 1 week of storage of the liquid formulation at 40°C. In contrast, upon lyophilization, no additional deamidation after 4 weeks at 40°C and no detectable changes in DNI structure or reduction in immunogenicity after 16 weeks at 40°C were observed. Vaccines containing aluminum hydroxide and GLA elicited higher immune responses than vaccines adjuvanted with only aluminum hydroxide, with more mice responding to a single dose.

Indexed as

Adjuvants, PharmaceuticAluminum HydroxideAnimalsAnthrax VaccinesDrug StabilityFemaleFreeze DryingFreezingGlassLipid AMiceMice, Inbred BALB CAdjuvants, PharmaceuticAluminum HydroxideAnthrax VaccinesLipid Aaluminumanthraxdominant negative inhibitorformulationfreeze-thawglycopyranoside lipid A (GLA)lyophilizationstabilityvaccine adjuvantsvaccines

Identifiers

PMID25581103
PMCPMC4312196
OpenAlexW2027217738

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.