BioCentury
ARTICLE | Clinical News

Recombinant botulism vaccine: Phase II data

January 30, 2012 8:00 AM UTC

A double-blind, placebo-controlled, U.S. Phase II trial in 440 healthy volunteers showed that intramuscular 0.5 mL doses of DynPort's recombinant botulism vaccine given on days 0, 28 and 182 or days 0, 56 and 182 produced maximum immune responses to both botulinum neurotoxin serotypes A and B at 28 days after the third dose. Additionally, detectable neutralizing antibody concentrations were maintained in >94% of subjects for >=1 year after the third dose. The vaccine was well tolerated with no significant differences in adverse events between treatment groups. The company said the 0, 28 and 182-day treatment regimen produced the strongest immune response and was selected for further evaluation. ...