Evidence map›Paper›PMID 32687736›Full record

ReviewHuman vaccines & immunotherapeutics2021

Outer membrane vesicles: moving within the intricate labyrinth of assays that can predict risks of reactogenicity in humans.

Omar Rossi, Francesco Citiulo, Francesca Mancini

Open access · bronzeAbstract readReview
In one paragraph

Review in Human vaccines & immunotherapeutics, 2021. 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
2.9field-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

24 citing papers in PubMed, 38 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Review
  6. Article
  7. Article
  8. Review
  9. TestingPharmaceutics · 2024
    Article
  10. Review
  11. Molecular Signature of Monocytes Shaped by theInternational journal of molecular sciences · 2024
    Article
  12. Article
  13. Optimization of EnterotoxigenicMicroorganisms · 2023
    Article
  14. Article
  15. Article
  16. Review
  17. Review
  18. Study of Agonists of TLRs as Vaccine Adjuvants.Methods in molecular biology (Clifton, N.J.) · 2023
    Article
  19. 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

3 authors at 1 institution in 1 country.

Omar RossiGSK Vaccines Institute for Global Health S.r.l (GVGH) , Siena, Italy.ORCID 0000-0002-0170-1285
Francesco CitiuloGSK Vaccines Institute for Global Health S.r.l (GVGH) , Siena, Italy.
Francesca ManciniGSK Vaccines Institute for Global Health S.r.l (GVGH) , Siena, Italy.
Toscana Life Sciences · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Outer membrane vesicles (OMV) are exosomes naturally released from the surface of Gram-negative bacteria. Since the '80s, OMVs have been proposed as powerful vaccine platforms due to their intrinsic self-adjuvanticity and ability to present multiple antigens in natural conformation. However, the presence of several pathogen-associated molecular patterns (PAMPs), especially lipid A, has raised concerns about potential systemic reactogenicity in humans. Recently, chemical and genetic approaches allowed to efficiently modulate the balance between reactogenicity and immunogenicity for the use of OMV in humans. Several assays (monocyte activation test, rabbit pyrogenicity test, limulus amebocyte lysate, human transfectant cells, and toxicology studies) were developed to test, with highly predictive potential, the risk of reactogenicity in humans before moving to clinical use. In this review, we provide a historical perspective on how different assays were and can be used to successfully evaluate systemic reactogenicity during clinical development and after licensure.

Indexed as

VaccinesAnimalsAntigen PresentationBacterial Outer Membrane ProteinsHumansLipid AMonocytesRabbitsBacterial Outer Membrane ProteinsLipid AVaccinesendotoxinfeverGMMAhumanmonocyte activation test (MAT)outer membrane vesicle (OMV)rabbit pyrogenicity test (RPT)reactogenicityTLRvaccine

Identifiers

PMID32687736
PMCPMC7899674
OpenAlexW3044066749

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.