Phase 1a clinical trial in Europe
In order to determine the safety and the maximum tolerable dose of the ShigETEC vaccine, a two-step first-in-human phase 1a clinical trial will be conducted in Europe. Healthy adult volunteers will be recruited after regulatory approval for the clinical trial form the National Regulatory Agency and ethics approval form the National and local Ethics Committees.
In the first step of the clinical trial, volunteers will be randomized into several groups for the sequential administration of increasing oral doses of the vaccine. Data on safety and tolerability, along with data on vaccine shedding, will allow to establish the optimal vaccine dose and the interval of administration for the next step.
In the second step, healthy adult volunteers will be enrolled for oral immunization with two, three, or four doses of the vaccine. Application of each additional dose will be done after evaluation of safety data by a Data Safety Monitoring Board that will determine whether it is appropriate to proceed with the next dose.
Results from the Phase 1a clinical trial will allow to select the optimal ShigETEC dosing and interval of administration for further evaluation in a Phase 1b clinical trial in endemic populations in Bangladesh.