The Journal of infectious diseases · 2026
Safety and Immunogenicity of a Trivalent Salmonella Conjugate Vaccine to S. Typhi, S. Typhimurium, and S. Enteritidis.
СтатьяРандомизированное исследованиеКлиническое исследование II фазыКлиническое исследование I фазыНазвание и аннотация: Перевод в очереди
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Chen Wilbur H, Beckett Charmagne G, Al-Ibrahim Mohamed, Datar Reva, Sikorski Michael J, Liang Yuanyuan, Pasetti Marcela F, Sztein Marcelo B, Wahid Rezwanul, Tennant Sharon M, Simon Raphael, Baliban Scott M, Galen James E, Lees Andrew, Ella Raches, Mohan Krishna, Naidu M Gangadhara, Rao D Yogeswara, Ella Krishna M, Levine Myron M
Аннотация
BACKGROUND: Invasive disease caused by typhoid and nontyphoidal Salmonella (NTS) is a threat confronting young children in sub-Saharan Africa. We are developing a trivalent Salmonella conjugate vaccine (TSCV) consisting of typhoid Vi conjugate and core-O-polysaccharide conjugates from 2 invasive NTS serovars (S. Typhimurium and S. Enteritidis).
METHODS: We conducted a randomized-controlled Phase 1/2a trial assessing the safety and immunogenicity of a full-strength TSCV (FS; 25 µg of all 3 polysaccharides), half-strength TSCV (HS; 25 µg of Vi and 12.5 µg of both NTS polysaccharides), dilutional half-strength TSCV (dilHS; 12.5 µg of all 3 polysaccharides), or placebo. Local and systemic adverse events were recorded and blood was collected for serum antibody and antibody-secreting cells (ASCs).
RESULTS: In total, 80 evaluable participants aged 20-47 years were enrolled. All vaccines were well tolerated; mild injection site pain and fatigue were the most common reactions reported. Serum antibody and ASC responses to the 3 primary polysaccharide antigens were robust, ranging between 85% and 100% response rates, with no statistically significant difference between the 3 formulations. No placebo recipients manifested significant antibody or ASC responses.
CONCLUSIONS: These data encourage the further development of TSCV to address a pressing public health problem in young children of sub-Saharan Africa.
METHODS: We conducted a randomized-controlled Phase 1/2a trial assessing the safety and immunogenicity of a full-strength TSCV (FS; 25 µg of all 3 polysaccharides), half-strength TSCV (HS; 25 µg of Vi and 12.5 µg of both NTS polysaccharides), dilutional half-strength TSCV (dilHS; 12.5 µg of all 3 polysaccharides), or placebo. Local and systemic adverse events were recorded and blood was collected for serum antibody and antibody-secreting cells (ASCs).
RESULTS: In total, 80 evaluable participants aged 20-47 years were enrolled. All vaccines were well tolerated; mild injection site pain and fatigue were the most common reactions reported. Serum antibody and ASC responses to the 3 primary polysaccharide antigens were robust, ranging between 85% and 100% response rates, with no statistically significant difference between the 3 formulations. No placebo recipients manifested significant antibody or ASC responses.
CONCLUSIONS: These data encourage the further development of TSCV to address a pressing public health problem in young children of sub-Saharan Africa.