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news.Denmark-based biopharmaceutical company Bavarian Nordic has reported the successful completion of Phase II trial of Imvamune next-generation smallpox vaccine candidate.
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The purpose of this study, aside from assessing general immune response and safety, was to compare cardiac safety in the different study groups following vaccination with Imvamune.
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 response in the majority of people who had historically been vaccinated against smallpox.
The results of the study are seen as the pivotal step for moving Imvamune into Phase III registration trials in order to achieve a BLA for healthy subjects and also for obtaining an emergency use authorization (EUA). This study completes the Phase II development of Imvamune in healthy subjects and now leads to planning with the FDA on the design of the Phase III studies expected to begin in 2008.
Anders Hedegaard, president & CEO of Bavarian Nordic, said: “We are very satisfied with these results which bring us closer to our EUA application, which represents an important milestone in the development of Imvamune as the modern smallpox vaccine.”