Trial reportThe Journal of infectious diseases2021
Functional Antibodies and Innate Immune Responses to WRSS1, a Live Oral Shigella sonnei Vaccine Candidate, in Bangladeshi Adults and Children.
Trial report in The Journal of infectious diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01813071 (A Randomized, Double-Blinded, Placebo-controlled, Dose-Escalation, Age-Descending Study to Assess the Safety and Tolerability of Live Attenuated, Oral Shigella WRSS1), which is not on this map. Cited by 12 papers.
What it found
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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 Randomized, Double-Blinded, Placebo-controlled, Dose-Escalation, Age-Descending Study to Assess the Safety and Tolerability of Live Attenuated, Oral Shigella WRSS1 (Walter Reed S. Sonnei) Vaccine in Bangladeshi Adults and Children
Who cites it
12 citing papers in PubMed, 17 citations in OpenAlex.
- Complement-mediated serum bactericidal activity of antibodies elicited by theFrontiers in immunology · 2022Trial
- Development of a NovelVaccines · 2026Article
- Shigellosis.Lancet (London, England) · 2025Review
- The fusion subunit vaccine L-DBF protects aged mice against heterologous lethalFrontiers in immunology · 2025Article
- Review
- Putative correlates of protection against shigellosis assessing immunomarkers across responses to S. sonnei investigational vaccine.NPJ vaccines · 2024Article
- Oral immunization withmSphere · 2024Article
- Shigella-Controlled Human Infection Models: Current and Future Perspectives.Current topics in microbiology and immunology · 2024Review
- Age-dependent acquisition of IgG antibodies toFrontiers in immunology · 2024Article
- Refining Immunogenicity through Intradermal Delivery of Outer Membrane Vesicles againstInternational journal of molecular sciences · 2023Article
- A Shigella flexneri 2a synthetic glycan-based vaccine induces a long-lasting immune response in adults.NPJ vaccines · 2023Article
- Systems approach to define humoral correlates of immunity to Shigella.Cell reports · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWe demonstrated in a randomized placebo-controlled trial that WRSS1, a live oral Shigella sonnei vaccine candidate, is safe in Bangladeshi adults and children, and elicits antigen-specific antibodies. Here, we describe functional antibody and innate immune responses to WRSS1.
methodsAdults (18-39 years) and children (5-9 years) received 3 doses of 3 × 105 or 3 × 106 colony forming units (CFU) of WRSS1 or placebo, 4 weeks apart; children additionally received 3 × 104 CFU. Blood and stool were collected at baseline and 7 days after each dose. Functional antibodies were measured using serum bactericidal antibody (SBA) assay. Cytokine/chemokine concentrations were measured in lymphocyte cultures. Host defense peptides LL-37, HBD-1, and HD-5 were analyzed in plasma and stool.
resultsChildren showed increased SBA titers over baseline after the third dose of 3 × 106 CFU (P = .048). Significant increases of Th-17 and proinflammatory cytokines (TNF-α, G-CSF, MIP-1β), and reduction of anti-inflammatory and Th2 cytokines (IL-10, IL-13, GM-CSF) were observed in children. Plasma HBD-1 and LL-37 decreased in children after vaccination but were increased/unchanged in adults.
conclusionsFunctional antibodies and Th1/Th17 cytokine responses in children may serve as important indicators of immunogenicity and protective potential of WRSS1. Clinical Trials Registration: NCT01813071.
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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.