Trial reportThe Journal of infectious diseases2026
Immunogenicity of a Bivalent Typhoid-Paratyphoid Conjugate Vaccine Against Diverse Salmonella Paratyphi A Isolates.
Trial report in The Journal of infectious diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05613205 (A Phase 1, Observer-blind, Randomised, Controlled, Single-centre Study to Evaluate the Safety, Reactogenicity, and Immune Responses to an Adjuvanted and Non-adjuvanted Conjugate Vaccine Against Salmonella Typhi and Salmonella Paratyphi A in Healthy Adults 18 to 50 Years of Age in Europe), which is not on this map. Not yet cited in PubMed.
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A Phase 1, Observer-blind, Randomised, Controlled, Single-centre Study to Evaluate the Safety, Reactogenicity, and Immune Responses to an Adjuvanted and Non-adjuvanted Conjugate Vaccine Against Salmonella Typhi and Salmonella Paratyphi A in Healthy Adults 18 to 50 Years of Age in Europe
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14 authors.
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Abstract
backgroundIn a first-in-human, phase 1, randomized controlled trial, a bivalent conjugate vaccine (Vi-CRM197 + O:2 CRM197) elicited robust immunoglobulin G (IgG) and bactericidal activity against vaccine-homologous Salmonella Paratyphi A strain. To further characterize the immune response, we assessed O:2 antigen-specific immunoglobulin A (IgA) and immunoglobulin M (IgM) responses as markers of mucosal immunity and early immune activation, and evaluated serum bactericidal activity against diverse S Paratyphi A isolates.
methodsThe trial (NCT05613205) was conducted in 3 steps. For this exploratory analysis, 46 participants (mean age 27.2 years; 67.4% women) from Step 2 who received 2 full doses of Vi-CRM197 + O:2 CRM197 vaccine with and without aluminum hydroxide (alum) 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.
resultsBoth formulations induced strong anti-O:2 IgA/IgM responses and bactericidal activity, with higher responses in the nonadjuvanted 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 nonadjuvanted formulation induced significantly higher IgA responses and bactericidal activity at day 29 (P < .05). Anti-O:2 IgM strongly correlated with bactericidal antibodies against homologous and heterologous strains.
conclusionsThe vaccine effectively induced O:2-specific IgA, IgM, and bactericidal antibodies against diverse S Paratyphi A isolates, indicating potential broad protection. Clinical Trials Registration. NCT05613205.
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