Evidence map›Paper›PMID 36243351›Full record

Trial reportClinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases2023

Threshold protective levels of serum IgG to Shigella lipopolysaccharide: re-analysis of Shigella vaccine trials data.

Dani Cohen, Shai Ashkenazi, Rachel Schneerson, Nahid Farzam, Anya Bialik, Shiri Meron-Sudai, Valeria Asato, Sophy Goren, Tomer Ziv Baran, Khitam Muhsen and 2 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing 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

22 citing papers in PubMed.

  1. Human vaccines & immunotherapeutics · 2026
    Review
  2. Article
  3. Article
  4. Shigellosis.Lancet (London, England) · 2025
    Review
  5. Article
  6. mBio · 2025
    Article
  7. Review
  8. Article
  9. Article
  10. International journal of molecular sciences · 2024
    Review
  11. Article
  12. IgG Serum Antibodies toVaccines · 2024
    Article
  13. Oral immunization withmSphere · 2024
    Article
  14. Age-dependent acquisition of IgG antibodies toFrontiers in immunology · 2024
    Article
  15. Review
  16. Review
  17. Article
  18. Article
  19. Toward aInternational journal of molecular sciences · 2023
    Review
  20. Functional assays to evaluate antibody-mediated responses againstFrontiers in cellular and infection microbiology · 2023
    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

12 authors.

Dani CohenDepartment of Epidemiology and Preventive Medicine, School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: dancohen@tauex.tau.ac.il.
Shai AshkenaziAdelson School of Medicine, Ariel University, Ariel, Israel; Schneider Children's Medical Center, Petach Tikva, Israel.
Rachel SchneersonNational Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.
Nahid FarzamDivision of Endocrinology, Diabetes and Metabolism, Sheba Medical Center, Tel Hashomer, Ramat Gan, Tel Aviv, Israel.
Anya BialikDepartment of Epidemiology and Preventive Medicine, School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Shiri Meron-SudaiDepartment of Epidemiology and Preventive Medicine, School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Valeria AsatoDepartment of Epidemiology and Preventive Medicine, School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Sophy GorenDepartment of Epidemiology and Preventive Medicine, School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Tomer Ziv BaranDepartment of Epidemiology and Preventive Medicine, School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Khitam MuhsenDepartment of Epidemiology and Preventive Medicine, School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Peter B GilbertVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA; Department of Biostatistics, University of Washington, Seattle, WA, USA.
Calman A MacLennanBill and Melinda Gates Foundation, London, United Kingdom; Nuffield Department of Medicine, Jenner Institute, University of Oxford, Oxford, United Kingdom.

Funding

Statistical Methods in HIV Vaccine Efficacy TrialsR37AI054165 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Peter B. Gilbert · 2010 to 2026
$6.7M
NIAID NIH HHS R37 AI054165
6 · The paper itself

Abstract

objectivesEstablishing a correlate of protection is essential for the development and licensure of Shigella vaccines. We examined potential threshold levels of serum IgG to Shigella lipopolysaccharide (LPS) that could predict protection against shigellosis.

methodsWe performed new analyses of serologic and vaccine efficacy (VE) data from two randomized vaccine-controlled trials of the Shigella sonnei-Pseudomonas aeruginosa recombinant exoprotein A (rEPA) conjugate conducted in young adults and children aged 1-4 years in Israel. Adults received either S. sonnei-rEPA (n = 183) or control vaccines (n = 277). Children received the S. sonnei-rEPA conjugate (n = 1384) or S. flexneri 2a-rEPA conjugate (n = 1315). VE against culture-proven shigellosis was determined. Sera were tested for IgG anti-S. sonnei LPS antibodies. We assessed the association of various levels of IgG anti-S. sonnei LPS antibodies with S. sonnei shigellosis risk using logistic regression models and the reverse cumulative distribution of IgG levels.

resultsAmong adults, four vaccinees and 23 controls developed S. sonnei shigellosis; the VE was 74% (95% CI, 28-100%). A threshold of ≥1:1600 IgG anti-S. sonnei LPS titre was associated with a reduced risk of S. sonnei shigellosis and a predicted VE of 73.6% (95% CI, 65-80%). The IgG anti-S. sonnei LPS correlated with serum bactericidal titres. In children, a population-based level of 4.5 ELISA Units (EU) corresponding to 1:1072 titre, predicted VE of 63%, versus 71% observed VE in children aged 3-4 years. The predicted VE in children aged 2-4 years was 49%, consistent with the 52% observed VE.

conclusionSerum IgG anti-S. sonnei LPS threshold levels can predict the degree of VE and can be used for the evaluation of new vaccine candidates.

Indexed as

Dysentery, BacillaryShigellaShigella VaccinesAntibodies, BacterialChildHumansImmunoglobulin GLipopolysaccharidesShigella flexneriShigella sonneiAntibodies, BacterialImmunoglobulin GLipopolysaccharidesShigella VaccinesConjugate vaccinesCorrelate of protectionImmunological substituteSerum IgGShigellaVaccine efficacy

Identifiers

PMID36243351
PMCPMC9993342

What OpenQuestion holds

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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.