{
  "abstract": "Background: Global oral cholera vaccine (OCV) supply shortages and the retirement of Shanchol necessitate absolute reliance on alternative formulations. We conducted a systematic review and meta-analysis to evaluate the immunogenicity and safety of Euvichol variants compared with the historical Shanchol benchmark. Methodology/Principal Findings: A searched PubMed, Embase, MEDLINE, Scopus, and Cochrane CENTRAL up to May 2026 for randomized controlled trials (RCTs) comparing any Euvichol variant against Shanchol in healthy populations aged [≥]1 year. Primary outcomes were vibriocidal seroconversion rates at 14 days post-dose 2 pooled as Risk Ratios (RRs) via Mantel-Haenszel fixed-effects models. Five RCTs comprising 7,253 participants were included. Euvichol formulations demonstrated non-inferior, equivalent seroconversion rates compared with Shanchol for both Vibrio cholerae O1 Inaba (RR 1.00, 95% CI 0.98-1.02; I2=0%) and O1 Ogawa (RR 1.01, 95% CI 0.99-1.04; I2=26%). Log-transformed Geometric Mean Titers confirmed clinical equivalence for Inaba (MD 0.02, 95% CI -0.01 to 0.05) and Ogawa (MD 0.00, 95% CI -0.03 to 0.03). Overall safety was balanced between arms, showing no significant variation in the risk of any solicited adverse event (RR 0.91, 95% CI 0.75-1.11) or specific symptoms including fever (RR 0.84, 95% CI 0.52-1.35). Serious adverse events were rare and uniformly unrelated to vaccination. Conclusions/Significance: Euvichol variants demonstrate immunogenic non-inferiority and interchangeable safety thresholds compared with Shanchol. These findings robustly support the large-scale integration of modern Euvichol-Plus and streamlined Euvichol-S formulations to stabilize global OCV stockpiles.",
  "abstract_shown": true,
  "affiliations": [
    "Amran University"
  ],
  "article_type": "New results",
  "arxiv": null,
  "author_total": 5,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "K. M. Al-Dhayani"
    },
    {
      "name": "Z. A. Hasan"
    },
    {
      "name": "K. B. A. Alastah"
    },
    {
      "name": "S. M. Altbal"
    },
    {
      "name": "M. S. Al-Eryani"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/28n9k8713escf.bib",
  "cited_by": 0,
  "doi": "10.64898/2026.09.19.752908",
  "fulltext_url": "https://www.biorxiv.org/content/10.64898/2026.09.19.752908v1.full",
  "id": "28n9k8713escf",
  "issns": [],
  "landing_url": "https://www.biorxiv.org/content/10.64898/2026.09.19.752908v1",
  "language": null,
  "licence": "CC-BY",
  "licence_label": "CC BY",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "biorxiv",
      "pharmacology and toxicology"
    ],
    [
      "openalex",
      "1310|Vibrio bacteria research studies"
    ]
  ],
  "openalex": "W7203573105",
  "pdf_url": "https://www.biorxiv.org/content/10.64898/2026.09.19.752908v1.full.pdf",
  "pmcid": null,
  "pmid": null,
  "published": "2026-09-19",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/28n9k8713escf.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:24:27Z",
      "native_id": "10.64898/2026.09.19.752908",
      "source": "biorxiv",
      "url": "https://www.biorxiv.org/content/10.64898/2026.09.19.752908v1"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "biorxiv:pharmacology and toxicology",
      "subfield": "pharmacology-toxicology"
    }
  ],
  "title": "Therapeutic Equivalence, Immunogenicity, and Safety of Euvichol Oral Cholera Vaccine Formulations Compared with WHO-prequalified Shanchol vaccine in Healthy Children and Adults: A Systematic Review and Meta-Analysis of Randomised Controlled Trials",
  "title_text": "Therapeutic Equivalence, Immunogenicity, and Safety of Euvichol Oral Cholera Vaccine Formulations Compared with WHO-prequalified Shanchol vaccine in Healthy Children and Adults: A Systematic Review and Meta-Analysis of Randomised Controlled Trials",
  "type": "preprint",
  "updated_at": "2026-10-30T12:24:27Z",
  "url": "https://research.draconitic.com/paper/28n9k8713escf",
  "venue": "bioRxiv",
  "versions": []
}