The purpose of this study is to assess the immune response produced by two doses of SC599 vaccine compared to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
111
CIC de Vaccinologie Cochin Pasteur
Paris, France
Dept of Cellular and Molecular Medicine, St George's Hospital Vaccine Institute
London, United Kingdom
Immune response assessed by the proportion of Immunoglobulin A (IgA) anti-Lipopolysaccharide (LPS) Antibody-Secreting Cells (ASC) responders.
1) Immune Response:
-Proportion of volunteers who have a B subunit antibody response
-Proportion of volunteers who have a LPS response
2) SC599 Shedding
-Proportion of volunteers who will excrete the vaccine strain and by the duration of the SC5999 shedding, defined as the time (days) between the first an last stool that were positive for SC599.
3) Safety Assessment
-The safety will be evaluated by the proportions of clinical and biological adverse events. Illness after vaccination will be defined as either diarrhoea or fever.
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