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.
Shigella4V2 is the second generation of a tetravalent bioconjugate vaccine including O-antigen-polysaccharides of the most predominant Shigella serotypes. During the study, infants will be randomized to receive 1 of 2 different vaccine doses, or a control vaccine. Participants will receive a 2-dose schedule. Each vaccine dose is formulated with Aluminium adjuvant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
110
Adjuvanted Shigella4V2 administrated at 2 different doses: low and high.
Control vaccine
KEMRI - Center for Global Health Research
Kisumu, Kenya
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: From first vaccination until 1 month following the second vaccination
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
Time frame: 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
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Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: From first vaccination up to 1 month post 2nd vaccination