Evidence map›Paper›PMID 37670042›Full record

ArticleNPJ vaccines2023

A next-generation GMMA-based vaccine candidate to fight shigellosis.

Omar Rossi, Francesco Citiulo, Carlo Giannelli, Emilia Cappelletti, Gianmarco Gasperini, Francesca Mancini, Alessandra Acquaviva, Maria Michelina Raso, Luigi Sollai, Renzo Alfini and 9 more

Open access · goldAbstract read
In one paragraph

Article in NPJ vaccines, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
4.9field-weighted citation impact, top 4% 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

26 citing papers in PubMed, 25 citations in OpenAlex.

  1. Trial
  2. Review
  3. Human vaccines & immunotherapeutics · 2026
    Review
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Shigellosis.Lancet (London, England) · 2025
    Review
  12. Review
  13. Review
  14. Review
  15. Article
  16. Article
  17. Immunogenicity evaluation of altSonflex1-2-3Frontiers in immunology · 2025
    Article
  18. 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

19 authors at 3 institutions in 4 countries.

Omar Rossi *GSK Global Health Vaccines R&D (GVGH), Siena, Italy.ORCID http://orcid.org/0000-0002-0170-1285
Francesco Citiulo *GSK Global Health Vaccines R&D (GVGH), Siena, Italy.
Carlo GiannelliGSK Global Health Vaccines R&D (GVGH), Siena, Italy.ORCID http://orcid.org/0000-0002-6112-6841
Emilia CappellettiGSK Global Health Vaccines R&D (GVGH), Siena, Italy.
Gianmarco GasperiniGSK Global Health Vaccines R&D (GVGH), Siena, Italy.
Francesca ManciniGSK Global Health Vaccines R&D (GVGH), Siena, Italy.
Alessandra AcquavivaGSK Global Health Vaccines R&D (GVGH), Siena, Italy.
Maria Michelina RasoGSK Global Health Vaccines R&D (GVGH), Siena, Italy.
Luigi SollaiGSK Global Health Vaccines R&D (GVGH), Siena, Italy.
Renzo AlfiniGSK Global Health Vaccines R&D (GVGH), Siena, Italy.
Maria Grazia ArutaGSK Global Health Vaccines R&D (GVGH), Siena, Italy.
Claudia Giorgina VitaliGSK Vaccines Srl, Siena, Italy.ORCID http://orcid.org/0009-0001-8793-3051
Mariagrazia PizzaGSK Global Health Vaccines R&D (GVGH), Siena, Italy.
Francesca NecchiGSK Global Health Vaccines R&D (GVGH), Siena, Italy.
Rino RappuoliGSK Vaccines Srl, Siena, Italy.
Laura B MartinGSK Global Health Vaccines R&D (GVGH), Siena, Italy.
Francesco Berlanda ScorzaGSK Global Health Vaccines R&D (GVGH), Siena, Italy.
Anna Maria ColucciGSK Global Health Vaccines R&D (GVGH), Siena, Italy.
Francesca MicoliGSK Global Health Vaccines R&D (GVGH), Siena, Italy. francesca.x.micoli@gsk.com.ORCID http://orcid.org/0000-0001-8243-3181
Toscana Life Sciences · ITGlaxoSmithKline (France) · FRUnited States Pharmacopeial Convention · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Shigellosis is a leading cause of diarrheal disease in low-middle-income countries (LMICs). Effective vaccines will help to reduce the disease burden, exacerbated by increasing antibiotic resistance, in the most susceptible population represented by young children. A challenge for a broadly protective vaccine against shigellosis is to cover the most epidemiologically relevant serotypes among >50 Shigella serotypes circulating worldwide. The GMMA platform has been proposed as an innovative delivery system for Shigella O-antigens, and we have developed a 4-component vaccine against S. sonnei, S. flexneri 1b, 2a and 3a identified among the most prevalent Shigella serotypes in LMICs. Driven by the immunogenicity results obtained in clinic with a first-generation mono-component vaccine, a new S. sonnei GMMA construct was generated and combined with three S. flexneri GMMA in a 4-component Alhydrogel formulation (altSonflex1-2-3). This formulation was highly immunogenic, with no evidence of negative antigenic interference in mice and rabbits. The vaccine induced bactericidal antibodies also against heterologous Shigella strains carrying O-antigens different from those included in the vaccine. The Monocyte Activation Test used to evaluate the potential reactogenicity of the vaccine formulation revealed no differences compared to the S. sonnei mono-component vaccine, shown to be safe in several clinical trials in adults. A GLP toxicology study in rabbits confirmed that the vaccine was well tolerated. The preclinical study results support the clinical evaluation of altSonflex1-2-3 in healthy populations, and a phase 1-2 clinical trial is currently ongoing.

Identifiers

PMID37670042
PMCPMC10480147
OpenAlexW4386443388

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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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.