Shigellosis Clinical Trial
Official title:
Safety and Tolerability of a Candidate Bioconjugate Vaccine Against Shigella Flexneri 2a When Administered to Adult Volunteers
This is a phase I, single-blind, randomized, placebo-controlled, single-center study in
healthy subjects using a staggered approach to dosing.
30 subjects will be randomized to receive 10 μg Flexyn2a candidate vaccine with or without
adjuvant or placebo.
A total of 30 subjects will be randomly assigned to one of 3 different arms in order to
evaluate the safety, tolerability and immunogenicity of a candidate vaccine, formulated with
or without adjuvant, and the outcome compared to a placebo control group.
For each active treatment group, 12 subjects will be injected twice with 10 μg Flexyn2a
candidate vaccine 4 weeks apart. A control group with 6 subjects will be injected following
the same schedule with a placebo solution.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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