Study to Expand Safety and Immunogenicity Data With Shigella Bioconjugate Vaccine (Shigella4V2) in 9-month-old Infants.
NCT Number: NCT06523231
Acronym: S4V02
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Shigellosis
Interventions: BIOLOGICAL: Shigella4V2|BIOLOGICAL: MenACWY
Sponsor: LimmaTech Biologics AG
Collaborators: Kenya Medical Research Institute
Sex: ALL
Age: CHILD
Enrollment: 110
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-11
Completion Date: 2025-11
Locations: KEMRI - Center for Global Health Research, Kisumu, 578,40100, Kenya

Summary:
In this study, the second-generation tetravalent bioconjugate candidate vaccine Shigella4V2 will be tested to confirm data on its safety and immunogenicity in infants and to identify the best dose of Shigella4V2 in 9-month-old infants.

Primary Outcome Measures: Safety - Solicited Local and Systemic Adverse Events (AEs), Safety and tolerability of the candidate vaccine Shigella4V2 as determined by occurrence, severity, and relationship of solicited AEs, During 7 days following each vaccination|Safety - Unsolicited Adverse Events (AEs), Safety and tolerability of the candidate vaccine Shigella4V2 as determined by occurrence, severity, and relationship of unsolicited AEs, During 28 days following each vaccination|Safety - Serious Adverse Events (SAEs), Safety and tolerability of the candidate vaccine Shigella4V2 as determined by occurrence, severity, and relationship of SAEs, Throughout the study, up to 9 months|Immunology - change in serum immunoglobulin G (IgG), Evaluation of geometric mean titers (GMT) and geometric mean ratios between baseline and 1-month post 2nd vaccination (GMR vs baseline) for serum IgG against the four Shigella serotypes included in the Shigella4V2 bioconjugate., From first vaccination until 1 month following the second vaccination
Secondary Outcome Measures: Safety - clinically significant changes in cell blood count (CBC) with differentials, Assess the safety of the candidate vaccine Shigella4V by measuring clinical significant changes in haematological safety parameters, From first vaccination until 7 days following each vaccination|Safety - clinically significant changes in creatinine level, Assess the safety of the candidate vaccine Shigella4V by measuring clinical significant changes in biochemical safety parameters, From first vaccination until 7 days following each vaccination|Safety - clinically significant changes in alanine aminotransferase (ALT) level, Assess the safety of the candidate vaccine Shigella4V by measuring clinical significant changes in biochemical safety parameters, From first vaccination until 7 days following each vaccination|Safety - clinically significant changes in aspartate aminotransferase (AST) level, Assess the safety of the candidate vaccine Shigella4V by measuring clinical significant changes in biochemical safety parameters, From first vaccination until 7 days following each vaccination|Immunogenicity - persistence of serum IgG, Evaluation of geometric mean titers (GMT) for serum IgG against the four Shigella serotypes included in Shigella4V2 at 6 months post 2nd vaccination., From first vaccination until 6 months post 2nd vaccination|Immunogenicity - change in serum IgG, Serum IgG responses and fold-increases between baseline and post-vaccination samples against the four Shigella serotypes included in the Shigella4V2 bioconjugate, From first vaccination until 6 months post 2nd vaccination|Immunogenicity - change in anti-Shigella lipopolysaccharide (LPS) antibody titers, Percentage of study participants achieving at least a four-fold increase in anti-Shigella LPS antibody titers (sero-responders) 1-month post 2nd vaccination compared to baseline., From first vaccination up to 1 month post 2nd vaccination