Evidence map›Paper›PMID 34430837›Full record

ArticleEClinicalMedicine2021

Efficacy, safety, and immunogenicity of the

Robert W Frenck, Valentino Conti, Pietro Ferruzzi, Augustin G W Ndiaye, Susan Parker, Monica Malone McNeal, Michelle Dickey, Juan Paolo Granada, Giulia Luna Cilio, Iris De Ryck and 14 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in EClinicalMedicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03527173 (Efficacy, Safety and Immunogenicity of GVGH Shigella Sonnei Vaccine), which is not on this map. Cited by 48 papers.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed
2.9field-weighted citation impact, top 7% 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.

NCT03527173 phase2completednot on this map

Efficacy, Safety and Immunogenicity of GVGH Shigella Sonnei Vaccine (1790GAHB) in a Human Challenge Study of Healthy Non-immune Adults

TypeinterventionalSponsorGlaxoSmithKlineRan2018 to 2019Enrolled71ConditionsDysentery, BacillaryArmsS.sonnei vaccine, Placebo, S. sonnei 53G challenge strain
3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 62 citations in OpenAlex.

  1. Trial
  2. Threshold protective levels of serum IgG to Shigella lipopolysaccharide: re-analysis of Shigella vaccine trials data.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2023
    Trial
  3. Trial
  4. Article
  5. Article
  6. Vaccine and Treatment Evaluation Units: A Historical Perspective.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Article
  7. Vaccine Treatment and Evaluation Units: Why Support a "Ready Base" of Clinical Trial Sites?Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Article
  8. Article
  9. Shigellosis.Lancet (London, England) · 2025
    Review
  10. Review
  11. Review
  12. A multifunctional anti-O-Antigen human monoclonal antibody protects againstProceedings of the National Academy of Sciences of the United States of America · 2025
    Article
  13. Article
  14. Review
  15. Article
  16. Review
  17. Article
  18. Article
  19. Article
  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

24 authors at 3 institutions in 2 countries.

Robert W FrenckDivision of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States.
Valentino ContiGSK Vaccines Institute for Global Health, Siena, Italy.
Pietro FerruzziGSK Vaccines Institute for Global Health, Siena, Italy.
Augustin G W NdiayeGSK Vaccines Institute for Global Health, Siena, Italy.
Susan ParkerDivision of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States.
Monica Malone McNealDivision of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States.
Michelle DickeyDivision of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States.
Juan Paolo GranadaGSK Vaccines Institute for Global Health, Siena, Italy.
Giulia Luna CilioGSK, Siena, Italy.
Iris De RyckGSK, Siena, Italy.
Francesca NecchiGSK Vaccines Institute for Global Health, Siena, Italy.
Akamol E SuvarnapunyaDepartment of Diarrheal Disease Research, Bacterial Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States.
Omar RossiGSK Vaccines Institute for Global Health, Siena, Italy.
Alessandra AcquavivaGSK Vaccines Institute for Global Health, Siena, Italy.
Lakshmi ChandrasekaranDepartment of Diarrheal Disease Research, Bacterial Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States.
Kristen A ClarksonDepartment of Diarrheal Disease Research, Bacterial Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States.
Joachim AuerbachGSK Vaccines Institute for Global Health, Siena, Italy.
Elisa MarchettiGSK Vaccines Institute for Global Health, Siena, Italy.
Robert W KaminskiDepartment of Diarrheal Disease Research, Bacterial Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States.
Francesca MicoliGSK Vaccines Institute for Global Health, Siena, Italy.
Rino RappuoliGSK Vaccines Institute for Global Health, Siena, Italy.
Allan SaulGSK Vaccines Institute for Global Health, Siena, Italy.
Laura B MartinGSK Vaccines Institute for Global Health, Siena, Italy.
Audino PoddaGSK Vaccines Institute for Global Health, Siena, Italy.
Toscana Life Sciences · ITCincinnati Children's Hospital Medical Center · USWalter Reed Army Institute of Research · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundShigellosis accounts for substantial morbidity and mortality worldwide and is the second most common cause of moderate and severe diarrhoea in children.

methodsThis phase 2b study (NCT03527173), conducted between August 2018 and November 2019, evaluated vaccine efficacy (VE), safety, and immunogenicity of a

findingsThirty-six and 35 participants received 1790GAHB or placebo, respectively; 33 and 29 were challenged, 15 and 12 developed shigellosis. VE was not demonstrated for any endpoint. Adverse events were more frequent in 1790GAHB versus placebo recipients post-vaccination. Anti-

interpretation1790GAHB had an acceptable safety profile and induced anti-LPS IgG responses but did not demonstrate clinical efficacy against shigellosis. Baseline/pre-challenge antibody levels were higher in participants who did not develop shigellosis post-challenge, suggesting a role of anti-LPS IgG antibodies in clinical protection, although not fully elucidated in this study. For further vaccine development an increased

fundingGlaxoSmithKline Biologicals SA, Bill and Melinda Gates Foundation.

Indexed as

1790GAHB vaccineControlled human infection modelGMMAHuman challenge studyShigella sonneiShigellosis

Identifiers

PMID34430837
PMCPMC8367798
OpenAlexW3194458127

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.