Trial reportThe Journal of infectious diseases2024
Safety and Immunogenicity of a 4-Component Generalized Modules for Membrane Antigens Shigella Vaccine in Healthy European Adults: Randomized, Phase 1/2 Study.
Trial report in The Journal of infectious diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT05073003 (A Staged Phase I/II Observer-blind, Randomised, Controlled, Multi-country Study to Evaluate the Safety, Reactogenicity, and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against S. Sonnei and S. Flexneri, Serotypes 1b, 2a, and 3a, in Adults in Europe), which is not on this map. Cited by 20 papers.
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.
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.
A Staged Phase I/II Observer-blind, Randomised, Controlled, Multi-country Study to Evaluate the Safety, Reactogenicity, and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against S. Sonnei and S. Flexneri, Serotypes 1b, 2a, and 3a, in Adults in Europe (Stage 1) Followed by Age De-escalation From Adults to Children and Infants, and Dose-finding in Infants in Africa (Stage 2)
Who cites it
20 citing papers in PubMed.
- Using Synthetic Glycans to Investigate Anti-Glycan Antibodies and Explore Their Medical Potential.Angewandte Chemie (International ed. in English) · 2026Review
- Robust performance of culture, real-time PCR, and genomic approaches for shigella serotyping in a pediatric surveillance cohort.PLoS neglected tropical diseases · 2026Article
- Computational structural dynamics and immunoinformatic analysis of EIEC IpaHMolecular diversity · 2026Article
- Outer membrane vesicles: Versatile nanocarriers for therapeutic delivery and immune modulation.Acta pharmaceutica Sinica. B · 2026Review
- Development of a NovelVaccines · 2026Article
- Robust Performance of Culture, qPCR, and Genomic Approaches for Shigella Serotyping in a Pediatric Surveillance Cohort.medRxiv : the preprint server for health sciences · 2026Article
- Preclinical evaluation of multivalent vaccine combinations againstFrontiers in immunology · 2026Article
- Evaluation of cross-functional antibody responses elicited by a four-component GMMA Shigella vaccine.NPJ vaccines · 2025Article
- Article
- Shigellosis.Lancet (London, England) · 2025Review
- De-risking vaccine development: lessons, challenges, and prospects.NPJ vaccines · 2025Review
- Bioengineering Outer-Membrane Vesicles for Vaccine Development: Strategies, Advances, and Perspectives.Vaccines · 2025Review
- Protein-specific immune response elicited by themSphere · 2025Article
- GMMA decorated with mucin 1 Tn/STn mimetics elicit specific antibodies response and inhibit tumor growth.NPJ vaccines · 2025Article
- Exploration of a GMMA-Based Bivalent Vaccine AgainstVaccines · 2025Article
- A Candidate AcVaccines · 2025Article
- Immunogenicity evaluation of altSonflex1-2-3Frontiers in immunology · 2025Article
- Antibodies elicited by altSonflex1-2-3 GMMA vaccine are bactericidal against a panel of drug-resistantFrontiers in immunology · 2025Article
- Vaccines as Potential Frontliners Against Antimicrobial Resistance (AMR): A Focused Review.Infection and drug resistance · 2025Review
- High-Throughput Luminescence-Based Serum Bactericidal Assay Optimization and Characterization to Assess Human Sera Functionality Against MultipleInternational journal of molecular sciences · 2024Article
Corrections and comments
- Erratum issued
Authors and funding
26 authors.
Funding
Abstract
backgroundWe report data from stage 1 of an ongoing 2-staged, phase 1/2 randomized clinical trial with a 4-component generalized modules for membrane antigens-based vaccine against Shigella sonnei and Shigella flexneri 1b, 2a, and 3a (altSonflex1-2-3; GSK).
methodsEuropeans aged 18-50 years (N = 102) were randomized (2:1) to receive 2 injections of altSonflex1-2-3 or placebo at 3- or 6-month interval. Safety and immunogenicity were assessed at prespecified time points.
resultsThe most common solicited administration-site event (until 7 days after each injection) and unsolicited adverse event (until 28 days after each injection) were pain (altSonflex1-2-3, 97.1%; placebo, 58.8%) and headache (32.4%; 23.5%), respectively. All serotype-specific functional IgG antibodies peaked 14-28 days after injection 1 and remained substantially higher than prevaccination at 3 or 6 months postvaccination; the second injection did not boost but restored the initial immune response. The highest seroresponse rates (≥4-fold increase in titers over baseline) were obtained against S. flexneri 2a (enzyme-linked immunosorbent assay [ELISA] after injection 1, 91.0%; after injection 2 [day 113; day 197], 100%; 97.0% and serum bactericidal activity [SBA] after injection 1, 94.4%; after injection 2, 85.7%; 88.9%) followed by S. sonnei (ELISA after injection 1, 77.6%; after injection 2, 84.6%; 78.8% and SBA after injection 1, 83.3%; after injection 2, 71.4%; 88.9%). Immune responses against S. flexneri 1b and S. flexneri 3a, as measured by both ELISA and SBA, were numerically lower compared to those against S. sonnei and S. flexneri 2a.
conclusionsNo safety signals or concerns were identified. altSonflex1-2-3 induced functional serotype-specific immune responses, allowing further clinical development in the target population. Clinical Trials Registration . NCT05073003.
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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.