This study evaluates the immune response and safety of a multicomponent, 2-dose Shigella vaccine in preventing shigellosis in African infants. The candidate vaccine, altSonflex1-2-3, is currently being evaluated in a Phase 2 age de-escalation (from least vulnerable adult population to most vulnerable paediatric population) clinical study in Kenya, with the aim of identifying a preferred dose, using a 3-dose vaccination schedule in infants from 9 months of age (NCT05073003). This Phase 2 clinical study will evaluate the safety and immunogenicity of an alternative 2-dose vaccination schedule.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Geometric mean titers (GMTs) of anti-serotype-specific Shigella lipopolysaccharides/O-antigen (LPS/OAg) serum Immunoglobulin G (IgG)
Timeframe: Day 1 (before administration of Dose 1)
GMTs of anti-serotype-specific Shigella LPS/OAg serum IgG
Timeframe: Day 169 (before administration of Dose 2)
GMTs of anti-serotype-specific Shigella LPS/OAg serum IgG
Timeframe: Day 29 (28 days after administration of Dose 1)
GMTs of anti-serotype-specific Shigella LPS/OAg serum IgG
Timeframe: Day 197 (28 days after administration of Dose 2)
Geometric mean concentrations (GMCs) of anti-serotype-specific Shigella LPS/OAg serum IgG
Timeframe: Day 1 (before administration of Dose 1)
GMCs of anti-serotype-specific Shigella LPS/OAg serum IgG
Timeframe: Day 169 (before administration of Dose 2)
GMCs of anti-serotype-specific Shigella LPS/OAg serum IgG
Timeframe: Day 29 (28 days after administration of Dose 1)
GMCs of anti-serotype-specific Shigella LPS/OAg serum IgG
Timeframe: Day 197 (28 days after administration of Dose 2)
Number of infants with at least a 4-fold increase in anti-serotype-specific Shigella LPS/OAg serum IgG
Timeframe: Day 29 compared with baseline (Day 1)
Number of infants with at least a 4-fold increase in anti-serotype-specific Shigella LPS/OAg serum IgG
Timeframe: Day 197 compared with baseline (Day 1)
Number of infants with at least a 4-fold increase in anti-serotype-specific Shigella LPS/OAg serum IgG
Timeframe: Day 197 compared with pre-Dose 2 (Day 169)