Trial reportVaccine2010
Age-related efficacy of Shigella O-specific polysaccharide conjugates in 1-4-year-old Israeli children.
Trial report in Vaccine, 2010. 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 4 registered trials, which are not on this map. Cited by 98 papers, 2 of them syntheses that pooled 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.
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.
Phase 3 Study (Safety, Immunogenicity and Efficacy) of Improved Shigella Conjugate Vaccines in 1-4 Year Olds in Israel
Shigella Sonnel O-SPC/rBRU Conjugate Vaccine
Safety and Immunogenicity of a Second Generation Shigella Bioconjugate Vaccine: a Phase II Randomized, Controlled, and Blinded Study in 9-month-old Infants
Phase 2b, Double-blind, Placebo-controlled Efficacy Challenge Study With the Shigella Tetravalent Bioconjugate Vaccine Shigella4V2
Who cites it
98 citing papers in PubMed, 2 syntheses or guidelines pooled it, 174 citations in OpenAlex.
- Burden of Shigella among children with diarrhea in the Americas: A systematic review and meta-analysis.PLoS neglected tropical diseases · 2025Pooled it
- Vaccines for the prevention of diarrhea due to cholera, shigella, ETEC and rotavirus.BMC public health · 2013Pooled it
- Efficacy of WRSs2, a live-attenuated Shigella sonnei vaccine, against shigellosis in a controlled human infection model in the USA: a phase 2, double-blind, randomised, placebo-controlled trial.The Lancet. Infectious diseases · 2026Trial
- 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 · 2023Trial
- A phase I trial of WRSS1, aHuman vaccines & immunotherapeutics · 2019Trial
- Trial
- Safety and Immunogenicity of a Candidate Bioconjugate Vaccine against Shigella flexneri 2a Administered to Healthy Adults: a Single-Blind, Randomized Phase I Study.Clinical and vaccine immunology : CVI · 2016Trial
- Clinical Trial of an Oral Live Shigella sonnei Vaccine Candidate, WRSS1, in Thai Adults.Clinical and vaccine immunology : CVI · 2016Trial
- Multifunctional antibody responses from a primateScience translational medicine · 2026Article
- Development of an 8-valentFrontiers in immunology · 2026Article
- Protective and pathogenic antibody responses from a primate Shigella outbreak inform vaccine design.bioRxiv : the preprint server for biology · 2025Article
- Young children have limited mucosal immunity when stimulated with an influenza vaccine in tonsil organoids.Research square · 2025Article
- Article
- Shigellosis.Lancet (London, England) · 2025Review
- A broad spectrum Shigella vaccine based on VirGNPJ vaccines · 2025Article
- Safety, Tolerability, and Immunogenicity of the InvaplexVaccines · 2025Article
- Article
- Synthesis of oligosaccharides from terminal B. pertussis LPS pentasaccharide and definition of the minimal epitope recognized by anti-pertussis antibodies.Glycoconjugate journal · 2024Article
- Evaluation of a QuadrivalentVaccines · 2024Article
- Review
38 more citing papers are in PubMed but not listed here.
Corrections and comments
- Erratum issued
Authors and funding
13 authors at 7 institutions in 2 countries.
Funding
Abstract
backgroundDespite its high worldwide morbidity and mortality, there is yet no licensed vaccine for shigellosis. We reported the safety and immunogenicity of Shigella O-specific polysaccharide-protein conjugates in adults and young children and efficacy of Shigella sonnei conjugate in young adults.
methodsA double-blinded, randomized and vaccine-controlled Phase 3 evaluation of S. sonnei and Shigella flexneri 2a O-SP-rEPA conjugates, 25 microg, injected IM twice, 6 weeks apart, into healthy 1-4 years old, is reported. The children were followed for 2 years by telephone every other week and stool cultures were obtained for each episode of acute diarrhea (> or =3 loose stools/day or a bloody/mucous stool). Sera were taken randomly from 10% of the participants for IgG anti-LPS and anti-carrier levels.
resultsOf the 2799 enrollees, 1433 received S. sonnei and 1366 S. flexneri 2a conjugates; 2699 (96.4%) completed the 2-year follow-up. Local reactions occurred in approximately 5% and approximately 4% had temperatures > or =38.0 degrees C lasting 1-2 days. There were no serious adverse events attributable to the vaccines. Of the 3295 stool cultures obtained, 125 yielded S. sonnei and 21 S. flexneri 2a. Immunogenicity and efficacy were age-related. The overall efficacy of the S. sonnei conjugate was 27.5%; 71.1% (P=0.043) in the 3-4 years old. The numbers for S. flexneri 2a were too few for meaningful analysis. Cross-protection by S. flexneri 2a for non-vaccine S. flexneri types was found, but the numbers were too few for statistical significance. There was an age-related rise of vaccine-specific IgG anti-LPS in both groups, peaking at about 10 weeks and declining thereafter, but remaining > or =4-fold higher than in the controls 2 years after the second dose.
conclusionsShigella conjugates are safe and immunogenic in 1-4 years old. The S. sonnei conjugate elicited 71.1% efficacy in the 3-4 years old and can be predicted to be efficacious in individuals older than 3 years of age. These results urge studies with our improved conjugates.
Indexed as
Identifiers
What OpenQuestion holds
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.