The Journal of infectious diseases · 2026
Immunogenicity of a Bivalent Typhoid-Paratyphoid Conjugate Vaccine Against Diverse Salmonella Paratyphi A Isolates.
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Carducci Martina, Sarakinou Eleanna, Massai Luisa, Rovetini Luca, AbdelGhany Mohammad, Fineschi Chiara, Nigro Simona, Marchetti Elisa, La Gaetana Rita, Scorza Francesco Berlanda, Arora Ashwani Kumar, Conti Valentino, Rossi Omar, Rondini Simona
Аннотация
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.
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.