Trial Under Government Scrutiny

Vaccine Study

Trial Under Government Scrutiny

SPONSOR

A lead developer of vaccines to prevent and treat infectious diseases. Sponsor was developing an investigational second-generation smallpox vaccine and in parallel was manufacturing emergency-use stockpiles of this investigational vaccine for the US Government and other governments around the world.

PROJECT

A Phase 2 dose-finding smallpox vaccine study in 600 healthy volunteers. Following the 9/11 attacks, this sponsor was awarded a government contract with National Institute of Allergy and Infectious Diseases (NIAID) to develop, manufacture and test a vaccine for use against potential bioterrorism. This vaccine development program was given Fast-track status by the FDA.

CHALLENGE

How do you quickly start up, enroll and database lock a study that is under significant government scrutiny following a terrorist act? The expectations for expeditious service were significant. ProTrials had previously provided project management and study monitoring services to this sponsor on two studies investigating the first generation of this vaccine. This study was for a modified version of the vaccine previously worked on; the sponsor chose ProTrials for this large, fast-enrolling study because we were already familiar and experienced with the vaccine and its unique handling requirements. The study procedures and numerous sites were carried over from the earlier studies. We assigned the same project manager from the earlier vaccine trials, as well as assigning 10 regionally-based CRAs to ensure frequent and up to date site monitoring.

RESULTS

Enrollment of 590 subjects was completed in four and a half months! The ProTrials team worked extremely quickly and closely with the site staff which resulted in meeting all timelines, including the database lock deadline.