Unlike other MS drugs in development, this one involves autologous t-cell therapy, a vaccine. The protocol requires that subjects wash out of their current MS therapies and undergo a 3-month screening period without therapy while the vaccine is manufactured.

A vaccination schedule is set from the date of randomization for each subject. Any changes in this schedule could jeopardize the vaccination and, ultimately, study results.

The PharmaNet Neuroscience team selected and managed many vendors to collect blood from 150+ participants at 36 different sites. The team arranged multiple meetings to discuss everyone’s responsibilities during the process to ensure that the vaccination schedule was maintained for each study participant.

Enrollment was completed despite a higher-than-expected screen failure rate. Very few subjects have had altered vaccination schedules which reduced variability of study results.