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
- 1Amran University
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.
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BibTeX
@misc{aldhayani2026therapeutic,
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}},
author = {K. M. Al-Dhayani and Z. A. Hasan and K. B. A. Alastah and S. M. Altbal and M. S. Al-Eryani},
howpublished = {bioRxiv},
year = {2026},
month = sep,
doi = {10.64898/2026.09.19.752908},
url = {https://www.biorxiv.org/content/10.64898/2026.09.19.752908v1},
note = {CC BY},
}
RIS
TY - UNPB
TI - 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
AU - K. M. Al-Dhayani
AU - Z. A. Hasan
AU - K. B. A. Alastah
AU - S. M. Altbal
AU - M. S. Al-Eryani
PY - 2026
DA - 2026/09/19
PB - bioRxiv
DO - 10.64898/2026.09.19.752908
UR - https://www.biorxiv.org/content/10.64898/2026.09.19.752908v1
AB - 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.
ER -