Dose Escalating Study of Intramuscular Invaplex[AR-DETOX]

Inclusion Criteria

• Healthy, adult, male or female, age 18 to 50 years (inclusive) at the time of enrollment.
• Completion and review of comprehension test (achieved ≥ 70% accuracy, two attempts allowed).
• Provide written informed consent before initiation of any study procedures.
• Agrees to complete all study visits and procedures and to provide a screening stool sample.
• Women of childbearing capacity: Negative pregnancy test with understanding (through informed consent process) to not become pregnant during the study or within three (3) months following the last vaccine dose.

Exclusion Criteria

• Health problems (for example, chronic medical conditions such as psychiatric conditions, diabetes mellitus, hypertension, or any other conditions that might place the subjects at increased risk of adverse events) - study clinicians, in consultation with the Principal Investigator (PI), will use clinical judgment on a case-by-case basis to assess safety risks under this criterion. The PI will consult with the Research Monitor as appropriate.
• History of autoimmune disorders, cardiovascular and renal disease.
• Use of immunosuppressive medications (systemic corticosteroids or chemotherapeutics that may influence antibody development), or immunosuppressive illness, including immunoglobulin A (IgA) deficiency (defined by serum IgA 2500 to Shigella flexneri 2a lipopolysaccharide antigen (LPS).
• History of microbiologically confirmed Shigella infection.
• Received previous licensed or experimental Shigella vaccine or live Shigella challenge.
• Travel to countries where Shigella or other enteric infections are endemic (most of the developing world) within two years prior to dosing (clinician judgement).
• Occupation involving handling of Shigella bacteria currently, or in the past 3 years.