The subjects were randomized to receive either three doses of BioThrax(R) or SparVax(TM) (at one of two dose levels followed by an antigenic challenge dose, i.e., a dose to show that the initial series of doses adequately "primed" the immune system to respond to natural infection by producing antibody due to immunologic memory.) The three dose groups were: 50 Microgram SparVax on Days 0, 28 and 56 (n = 91); 100 Microgram SparVax on Days 0, 28 and 56 (n = 92), and; 0.5 mL BioThrax(R) on Days 0, 14, and 28 (n = 43). At day 182, subjects receiving SparVax(TM) were re-randomized to a challenge at the original dose, on either day 182 or 364. The antigenic challenge dose (50 or 100 Microgram) each subject received was the same as the dose assigned to that subject during the initial vaccination schedule. Safety and immunogenicity were assessed throughout the study.
BioThrax(R) subjects were allowed to complete the full course of treatment, but data were not collected from these subjects after Day 70. Subjects who continued in the study were followed up for 18 months (Day 546) from the original vaccine dose.
Study results showed that there were an increased proportion of individuals experiencing injection site pain in the BioThrax(R) group as compared to the SparVax(TM) groups at both dose levels. There were no notable differences between the SparVax(TM) groups and the BioThrax(R) group regarding safety laboratory values, vital signs and ECG results. Additionally, in th
|SOURCE PharmAthene, Inc.|
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