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Bavarian Nordic reports the successful completion of a large, placebo-controlled Phase II trial in 745 healthy subjects who received either one or two doses of IMVAMUNE® third-generation smallpox vaccine
KVISTGAARD, Denmark | November 29, 2007 | Bavarian Nordic reports the successful completion of a large, placebo-controlled Phase II trial in 745 healthy subjects who received either one or two doses of IMVAMUNE® third-generation smallpox vaccine. The results of this study are seen as the pivotal step on the path to moving into Phase III registration trials in order to achieve a BLA for healthy subjects.
The study, together with other Phase II studies with IMVAMUNE® in immune-compromised persons, is pivotal for obtaining an Emergency Use Authorization (EUA). The company still expects to receive approval of the EUA application in second half of 2008.
Traditional smallpox vaccines are associated with a high risk of heart complications (e.g. myo-/pericarditis) in approximately 1 in every 150 people vaccinated for the first time. Therefore, aside from assessing general immune response and safety, the primary focus of this study was to compare cardiac safety in the different study groups following vaccination with IMVAMUNE®. The large amount of safety data collected from the 745 people who completed this study confirmed the excellent safety and tolerability profile of IMVAMUNE®. Importantly, vaccinations with IMVAMUNE® did not result in any clinically significant abnormal cardiac findings and no cardiac events (e.g. cases of myo-/pericarditis) that have been reported for traditional smallpox vaccines.
Moreover, vaccinations with IMVAMUNE® resulted in seroconversion (detectable immune responses) in almost all subjects (98.9%) previously not vaccinated against smallpox. Similarly, a single vaccination with IMVAMUNE® boosted the immune responses in the majority of people whom had historically already been vaccinated against smallpox.
This study completes the Phase II development of IMVAMUNE® in healthy subjects and this now leads to planning with the FDA on the design of the Phase III study that is planned to commence in 2008.
Anders Hedegaard, President & CEO, said: “We are very satisfied with these results which brings us closer to our EUA application which represents an important milestone in the development of IMVAMUNE® as the modern smallpox vaccine the world has been waiting for.”
SOURCE: Bavarian Nordic |
