Immunogenicity of a Bivalent Typhoid–Paratyphoid Conjugate Vaccine Against Diverse Salmonella Paratyphi A Isolates

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ID: 315823
2026
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Abstract
Abstract Background In a first-in-human phase-1, randomized, controlled trial, a bivalent conjugate vaccine (Vi-CRM197+O:2 CRM197) elicited robust IgG and bactericidal activity against vaccine-homologous Salmonella Paratyphi A strain. To further characterize the immune response, we assessed O:2 antigen-specific IgA and IgM responses as markers of mucosal immunity and early immune activation, and evaluated serum bactericidal activity against diverse S. Paratyphi A isolates. Method The trial (NCT05613205) was conducted in three steps. For this exploratory analysis, 46 participants (mean age 27.2 years; 67.4% women) from Step-2 who received two full doses of Vi-CRM197+O:2 CRM197 vaccine with and without Alum (Aluminum hydroxide) 169 days apart were considered. O:2-specific IgA/IgM responses and bactericidal antibodies were assessed. Geometric mean titers and concentrations, and within-participant geometric mean ratios were calculated. Results Both formulations induced strong anti-O:2 IgA/IgM responses and bactericidal activity, with higher responses in the non-adjuvanted group. At Day-29 post-dose 1, IgA rose 74.14- and 16.65-fold (without vs. with Alum), remaining well above baseline through Day-197. The non-adjuvanted formulation induced significantly higher IgA responses and bactericidal activity at Day-29 (p <0.05). Anti-O:2 IgM strongly correlated with bactericidal antibodies against homologous and heterologous strains. Conclusion The vaccine effectively induced O:2-specific IgA, IgM, and bactericidal antibodies against diverse S. Paratyphi A isolates, indicating potential broad protection.
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Authors Martina Carducci, Eleanna Sarakinou, Luisa Massai, Luca Rovetini, Mohammad AbdelGhany, Chiara Fineschi, Simona Nigro, Elisa Marchetti, Rita La Gaetana, Francesco Berlanda Scorza, Ashwani Kumar Arora, Valentino Conti, Omar Rossi, Simona Rondini
Journal The Journal of infectious diseases
Year 2026
DOI
10.1093/infdis/jiag275
URL
https://doi.org/10.1093/infdis/jiag275
Keywords Keywords not found

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