Acambis suspend smallpox trials
Acambis from Cambridge UK and Cambridge, US, has suspended the recruitment of additional volunteers into its Phase III clinical trials involving its investigational smallpox vaccine ACAM2000 and Dryvax, the comparator smallpox vaccine being used in the trials.
Acambis from Cambridge UK and Cambridge, US, has suspended the recruitment of additional volunteers into its Phase III clinical trials involving its investigational smallpox vaccine ACAM2000 and Dryvax, the comparator smallpox vaccine being used in the trials.
This precautionary measure was taken after three suspected myopericarditis cases were discovered in both ACAM2000 and Dryvax-vaccinated subjects. Myopericarditis is a condition where there is an inflammation of the heart and surrounding tissues.
Acambis' independent Data and Safety Monitoring Board (DSMB) recommended that enrolment into the studies be suspended pending further review and until additional data can be obtained. As a precaution, Acambis has also suspended another, smaller study vaccinating individuals with ACAM2000 and Dryvax. Once this analysis is completed, including the involvement of the DSMB, Acambis will be enlisting the assistance of the FDA and the US Centers for Disease Control and Prevention to determine the next steps.