Clinical Trials Director's Comments

Richard Rupp, MD
Director

Human trials are a critical step in vaccine development. The Clinical Trials Group was established by the SCVD to handle the evaluation of vaccine efficacy, immunogenicity and safety in humans. The team of investigators and coordinators within the Clinical Trials Group is experienced in all phases of vaccine trials from first-in-human phase I studies through post-marketing studies. Additionally, the group works with investigational drugs and biologics against infectious diseases in the neonatal nursery. The group has proven success with study populations spanning the lifespan from infants to the elderly.

The Clinical Trials Group handles a mix of industry and NIH-funded projects. It provides administrative oversight, including IRB submission and reporting, facilitation of budget and contract negotiations, management of regulatory documentation, and comprehensive operational support. The office utilizes an on-site laboratory to manage sample processing and shipping. The physicians, coordinators and research assistants are all trained in Good Clinical Practice (GCP). The office is frequently commended by its sponsors for swift study setup, exceeding recruitment goals, high retention rates and quality data.

FY 2010 was a productive year. The group proudly finished a number of projects including meningococcal vaccine (MCV4) studies in children and teens and an infant pneumococcal vaccine study. The group also concluded a 2009-2010 seasonal influenza vaccine study in the elderly. The crowning jewel of the year was the completion of a NIH sponsored infant and child study of a vaccine for the pandemic novel H1N1 influenza.

As these studies closed, others began in 2010. The group began enrollment for two infant studies: an industry sponsored pneumococcal vaccine and a NIH sponsored study on the use of both licensed Rotavirus vaccines in subjects. Enrollment was also completed on a NIH adult study on an avian influenza vaccine. Other studies continued through the year included cytomegalovirus (CMV) and meningococcal (MCV4) studies.

In the Infant Special Care Unit, we placed a number of infants into a study involving an antifungal medication and another study utilizing a monoclonal antibody to prevent staphylococcal infections. Overall, the group enrolled 377 volunteers into seven different trials. The youngest subject was a 24 week premature infant and the oldest was an 86 year old seasoned citizen.

Future studies that are being initiated for FY 2011 include industry sponsored trials on the concomitant use of a meningococcal b vaccine with routine adolescent vaccines and the use of a herpes zoster vaccine in adults with cancer. The Clinical Trials Group is also working to expand its operations by establishing a mainland presence and through collaborations on vaccine trials for chronic diseases alongside other university groups.