Evidence map›Paper›PMID 31569760›Full record

ReviewVaccines2019

Establishing Preferred Product Characterization for the Evaluation of RNA Vaccine Antigens.

Cristina Poveda, Amadeo B Biter, Maria Elena Bottazzi, Ulrich Strych

Abstract readReview
In one paragraph

Review in Vaccines, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing 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

28 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Review
  5. Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. Review
  11. An antibody-free evaluation of an mRNA COVID-19 vaccine.Biologicals : journal of the International Association of Biological Standardization · 2024
    Article
  12. Generation and Characterization of In Vitro Transcribed mRNA.Methods in molecular biology (Clifton, N.J.) · 2024
    Article
  13. Article
  14. Article
  15. mRNA-Based Nanomedicine: A New Strategy for Treating Infectious Diseases and Beyond.European journal of drug metabolism and pharmacokinetics · 2023
    Review
  16. Review
  17. Article
  18. Review
  19. Advances in COVID-19 mRNA vaccine development.Signal transduction and targeted therapy · 2022
    Review
  20. 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

4 authors.

Cristina PovedaDepartment of Pediatrics, National School of Tropical Medicine, Baylor College of Medicine, One Baylor Plaza, BCM113 Houston, TX 77030, USA. Cristina.Poveda@bcm.edu.
Amadeo B BiterDepartment of Pediatrics, National School of Tropical Medicine, Baylor College of Medicine, One Baylor Plaza, BCM113 Houston, TX 77030, USA. Amadeo.Biter@bcm.edu.
Maria Elena BottazziTexas Children's Hospital Center for Vaccine Development, Baylor College of Medicine, 1102 Bates Street, Houston, TX 77030, USA. bottazzi@bcm.edu.
Ulrich StrychDepartment of Pediatrics, National School of Tropical Medicine, Baylor College of Medicine, One Baylor Plaza, BCM113 Houston, TX 77030, USA. strych@bcm.edu.ORCID 0000-0001-9455-7683

Funding

Robert J. and Helen C. Kleberg Foundation n/aTexas Children's Hospital n/a
6 · The paper itself

Abstract

The preferred product characteristics (for chemistry, control, and manufacture), in addition to safety and efficacy, are quintessential requirements for any successful therapeutic. Messenger RNA vaccines constitute a relatively new alternative to traditional vaccine development platforms, and thus there is less clarity regarding the criteria needed to ensure regulatory compliance and acceptance. Generally, to identify the ideal product characteristics, a series of assays needs to be developed, qualified and ultimately validated to determine the integrity, purity, stability, and reproducibility of a vaccine target. Here, using the available literature, we provide a summary of the array of biophysical and biochemical assays currently used in the field to characterize mRNA vaccine antigen candidates. Moreover, we review various in vitro functional cell-based assays that have been employed to facilitate the early assessment of the biological activity of these molecules, including the predictive immune response triggered in the host cell. Messenger RNA vaccines can be produced rapidly and at large scale, and thus will particularly benefit from well-defined and well-characterized assays ultimately to be used for in-process, release and stability-indications, which will allow equally rapid screening of immunogenicity, efficacy, and safety without the need to conduct often lengthy and costly in vivo experiments.

Indexed as

antigen presenting cellscappingdendritic cellsproduct characteristicstherapeutics

Identifiers

PMID31569760
PMCPMC6963847

What OpenQuestion holds

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LicenceCC BY
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.