Evidence map›Paper›PMID 30221194›Full record

Trial reportScience advances2018

The adjuvant GLA-AF enhances human intradermal vaccine responses.

Darrick Carter, Neal van Hoeven, Susan Baldwin, Yotam Levin, Efrat Kochba, Al Magill, Nathalie Charland, Nathalie Landry, Khin Nu, Aude Frevol and 4 more

Open access · goldAbstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Science advances, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed
2.8field-weighted citation impact, top 9% 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

25 citing papers in PubMed, 43 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Vaccine adjuvants: mechanisms and platforms.Signal transduction and targeted therapy · 2023
    Review
  5. Emerging adjuvants for intradermal vaccination.International journal of pharmaceutics · 2023
    Review
  6. Review
  7. Review
  8. Article
  9. Article
  10. Influenza vaccines: Past, present, and future.Reviews in medical virology · 2022
    Review
  11. Article
  12. Review
  13. Developments in Vaccine Adjuvants.Methods in molecular biology (Clifton, N.J.) · 2022
    Review
  14. Review
  15. Article
  16. Review
  17. Review
  18. Review
  19. Optimizing a Multi-Component IntranasalFrontiers in immunology · 2021
    Article
  20. 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

14 authors at 3 institutions in 2 countries.

Darrick CarterInfectious Diseases Research Institute, Seattle, WA 98102, USA.ORCID 0000-0001-5901-3402
Neal van HoevenInfectious Diseases Research Institute, Seattle, WA 98102, USA.
Susan BaldwinInfectious Diseases Research Institute, Seattle, WA 98102, USA.ORCID 0000-0003-4543-9239
Yotam LevinNanoPass Technologies Ltd., Nes Ziona, Israel.ORCID 0000-0002-0811-2870
Efrat KochbaNanoPass Technologies Ltd., Nes Ziona, Israel.ORCID 0000-0002-2954-7232
Al MagillDefense Advanced Research Projects Agency, Arlington, VA 22203, USA.
Nathalie CharlandMedicago, Québec City, Québec, Canada.
Nathalie LandryMedicago, Québec City, Québec, Canada.ORCID 0000-0003-3500-0484
Khin NuInfectious Diseases Research Institute, Seattle, WA 98102, USA.
Aude FrevolInfectious Diseases Research Institute, Seattle, WA 98102, USA.ORCID 0000-0002-8661-2942
Jill AshmanInfectious Diseases Research Institute, Seattle, WA 98102, USA.
Zachary K SagawaInfectious Diseases Research Institute, Seattle, WA 98102, USA.
Anna Marie BeckmannInfectious Diseases Research Institute, Seattle, WA 98102, USA.
Steven G ReedInfectious Diseases Research Institute, Seattle, WA 98102, USA.ORCID 0000-0003-2193-100X
Infectious Disease Research Institute · USMedicago (Canada) · CADefense Advanced Research Projects Agency · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Adjuvants are key to shaping the immune response to vaccination, but to date, no adjuvant suitable for human use has been developed for intradermal vaccines. These vaccines could be self-administered and sent through the mail as they do not require long needles or technical expertise in immunization. In the event of a pandemic outbreak, this approach could alleviate the congregation of patients in health centers and thus reduce the potential of these centers to enhance the spread of lethal infection. A reliable and potent vaccine system for self-administration would provide an effective countermeasure for delivery through existing product distribution infrastructure. We report results from preclinical and clinical trials that demonstrate the feasibility of an adjuvanted, intradermal vaccine that induced single shot protection in ferrets and seroprotection in humans against one of the more lethal strains of pandemic flu, Indonesia H5N1. In the human trial, the vaccine was safe and clinical responses were above approvable endpoints for a protective flu vaccine. Inclusion of a modern TLR4 (Toll-like receptor 4) agonist-based adjuvant was critical to the development of the response in the intradermal groups. In humans, this is the first report of a safe and effective intradermal adjuvant, GLA-AF (aqueous formulation of glucopyranosyl lipid adjuvant), and provides a future path for developing a vaccine-device combination for distribution by mail and self-administration in case of a pandemic.

Indexed as

1,2-DipalmitoylphosphatidylcholineAdjuvants, ImmunologicAdultAnimalsDrug CombinationsFemaleFerretsGuinea PigsHumansInfluenza A Virus, H5N1 SubtypeInfluenza VaccinesInjections, IntradermalLipid AMaleMice, Inbred C57BLToll-Like Receptor 41,2-DipalmitoylphosphatidylcholineAdjuvants, ImmunologicDrug CombinationsGLA-AF adjuvantInfluenza VaccinesLipid ATLR4 protein, humanToll-Like Receptor 4

Identifiers

PMID30221194
PMCPMC6136895
OpenAlexW2890481427

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.