Healthy volunteers will receive a 2-dose vaccination with Shigella dysenteriae candidate vaccine spaced 8 weeks apart. The objective is to demonstrate the safety and reactogenicity of the Shigella dysenteriae bioconjugate vaccine (GVXN SD133) alone or in combination with an adjuvant (Aluminium Hydroxide). The safety and reactogenicity of the GVXN SD133 vaccine will be also evaluated at two different concentrations of antigen, Shigella polysaccharide O1. Blood samples will be collected at intervals to examine systemic vaccine antigen-specific immune responses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
40
Two intramuscular injections of bioconjugate vaccine will be administrated at D0 and D60.
Institute of Social and Preventive Medicine
Zurich, Switzerland
Safety and reactogenicity of the bioconjugate vaccine, GVXN SD133
Time frame: Each study visits and at the and of the study
Humoral immunogenicity
Time frame: at day 0, 30, 60, 90 and 150
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