Safety Study of P28GST Treatment in Crohn's Disease Patients

To carry out this study, 24 moderate CD patients will be enrolled in a safety phase 2a study. CD patients will be included after intestinal resection surgery or in moderate Crohn's Disease (CD). Drug therapy will consisted in 3 injections of 100 µg of P28GST within 3 months (one injection per month). The main objective of this study is to follow-up monthly rate and seriousness of adverse events during one year. Secondary objectives are to control immunologic and inflammatory blood and tissue markers, appearance or not of a clinical recurrence assessed by CDAI (Crohn Disease Activity Index).

Inclusion criteria

• Subjects between the ages of ≥18 years at inclusion.
• Subjects with ileal or ileo-colic CD without fistula
• Subjects operated or not
• CDAI score < 220
• no concomitant treatment excepted salicylates
• Women of child bearing potential must be negative for pregnancy prior to study enrolment
• contraceptive means : females of childbearing potential as well as males are required to use adequate contraceptive methods for 6 months starting at the inclusion, i;e 4 months after the 3rd injection .
• No tobacco consumption (end date of tobacco consumption 8 days before surgery).
• Signed consent form
• French social security coverage.

Exclusion criteria

• Subject who use of azathioprine, anti-TNF (Tumor Necrosis Factor), methotrexate, Vedolizumab, Ustekinumab and other immunosuppressors for 8 weeks before first injection of P28GST
• Subject who use of corticosteroids for 15 days before first injection of P28GST
• Subject with history of vaccine hyper sensitivity or allergy.
• Subject with any other clinical manifestation determined by the investigator
• Subject wih AIDS, B or C hepatitis.