Evidence map›Paper›PMID 38459072›Full record

ArticleNPJ vaccines2024

Putative correlates of protection against shigellosis assessing immunomarkers across responses to S. sonnei investigational vaccine.

Valentino Conti, Omar Rossi, Kristen A Clarkson, Francesca Mancini, Usman N Nakakana, Eleanna Sarakinou, Andrea Callegaro, Pietro Ferruzzi, Alessandra Acquaviva, Ashwani Kumar Arora and 7 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in NPJ vaccines, 2024. 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 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
6.2field-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.

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

8 citing papers in PubMed, 10 citations in OpenAlex.

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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

17 authors at 7 institutions in 4 countries.

Valentino ContiGSK Vaccines Institute for Global Health, Siena, Italy.
Omar RossiGSK Vaccines Institute for Global Health, Siena, Italy.ORCID http://orcid.org/0000-0002-0170-1285
Kristen A ClarksonDepartment of Diarrheal Disease Research, Bacterial Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, MD, USA.
Francesca ManciniGSK Vaccines Institute for Global Health, Siena, Italy.
Usman N NakakanaGSK Vaccines Institute for Global Health, Siena, Italy. usman.n.nakakana@gsk.com.ORCID http://orcid.org/0000-0002-4885-9485
Eleanna SarakinouGSK Vaccines Institute for Global Health, Siena, Italy.
Andrea CallegaroGSK, Rixensart, Belgium.
Pietro FerruzziGSK Vaccines Institute for Global Health, Siena, Italy.
Alessandra AcquavivaGSK Vaccines Institute for Global Health, Siena, Italy.
Ashwani Kumar AroraGSK Vaccines Institute for Global Health, Siena, Italy.
Elisa MarchettiGSK Vaccines Institute for Global Health, Siena, Italy.
Francesca NecchiGSK Vaccines Institute for Global Health, Siena, Italy.
Robert W FrenckDivision of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Laura B MartinGSK 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, MD, USA.
Audino PoddaGSK Vaccines Institute for Global Health, Siena, Italy.
Francesca MicoliGSK Vaccines Institute for Global Health, Siena, Italy.ORCID http://orcid.org/0000-0001-8243-3181
Toscana Life Sciences · ITCincinnati Children's Hospital Medical Center · USGlaxoSmithKline (Belgium) · BEGlaxoSmithKline (India) · INHorizon Therapeutics (United States) · USUnited States Pharmacopeial Convention · USWalter Reed Army Institute of Research · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Shigella spp. are a leading bacterial cause of diarrhea. No widely licensed vaccines are available and there is no generally accepted correlate of protection. We tested a S. sonnei Generalized Modules for Membrane Antigen (GMMA)-based vaccine (1790GAHB) in a phase 2b, placebo-controlled, randomized, controlled human infection model study (NCT03527173) enrolling healthy United States adults aged 18-50 years. We report analyses evaluating immune responses to vaccination, with the aim to identify correlates of risk for shigellosis among assessed immunomarkers. We found that 1790GAHB elicited S. sonnei lipopolysaccharide specific α4β7+ immunoglobulin (Ig) G and IgA secreting B cells which are likely homing to the gut, indicating the ability to induce a mucosal in addition to a systemic response, despite parenteral delivery. We were unable to establish or confirm threshold levels that predict vaccine efficacy facilitating the evaluation of vaccine candidates. However, serum anti-lipopolysaccharide IgG and bactericidal activity were identified as potential correlates of risk for shigellosis.

Identifiers

PMID38459072
PMCPMC10923941
OpenAlexW4392601764

What OpenQuestion holds

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LicenceCC BY
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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.