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
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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.
