Human proof of concept studies

Following the successful completion of the animal studies, the vaccine is now being prepared for use in CD patients. Two proof of concept studies are planned; a Phase 1 safety study in healthy volunteers, and a Phase 2a study in MAP-infected CD patients to determine the safety and efficacy of the vaccine in a clinical setting.

The safety of the MVA vector has been established in numerous clinical studies undertaken by The Jenner Institute, Oxford University and by other respected bodies. The vaccine for human use will employ a new simian adenovirus vector as the second vector. While the overall safety of other simian vectors has already been established in clinical trials by Jenner, the safety of the new adenovirus vector will be determined in a 3+3 dose escalation Phase 1 study following protocols used in past studies.

The primary endpoint for the Phase 2a study in MAP-infected CD patients will be safety. The secondary endpoints will be the immunological, clinical and specific microbiological efficacy.