Purpose: The process of gaining approval for and implementing clinical trials is complex. Protocol, which involves either a live or attenuated vaccine and/or recombinant genetic material, generates additional layers of complexity. Our purpose is to share details of the process by which we navigated the approval process.
Methods: We conducted a review of all documentation relevant to the approval process for the clinical trial of a vaccine delivered by a live, recombinant DNA viral vector capable of transient replication in the host. We reviewed both institutional requirements and restrictions in the context of the aims and objectives of the clinical trial. Using what we learned from this first experience, we prepared a flow chart demonstrating a more efficient strategy for navigating the approval process.
Results: We present here the timeline for our approval process and will discuss ways to expedite the process. We will discuss requirements unique to biological agents. In addition, we will discuss the specific safety measures required for use of a live, recombinant vaccine.
Conclusions: Getting to the point of readiness to enroll patients was truly a collaborative effort; the preparation involved many people in a number of disciplines. This information should prove useful for other VA facilities that seek to implement similar clinical trials involving live, recombinant vaccine vectors.
