Bavarian Nordic initiate a Phase II clinical trial with IMVAMUNE™ in HIV infected patients
Bavarian Nordic has initiated a Phase II trial to investigate the safety and immunogenicity of IMVAMUNE™ in HIV infected subjects. The trial involves 150 volunteers and is being conducted at 5 sites in the United States. This is Bavarian Nordic’s second clinical study to evaluate the safety of IMVAMUNE™ in HIV infected patients and are the only studies evaluating MVA as a safe smallpox vaccine in this population of people, which are contradicted to traditional smallpox vaccines.
Recently, Bavarian Nordic also completed enrolment and vaccination in a Phase I clinical study with subjects suffering from atopic dermatitis, another population of people that should not be vaccinated with traditional smallpox vaccines. No serious or unexpected adverse reactions were reported following vaccinations with IMVAMUNE™.
Furthermore, Bavarian Nordic has already completed two trials with a recombinant MVA based HIV vaccine in HIV infected subjects and have an ongoing Phase II trial with this vaccine. In these studies Bavarian Nordic has already vaccinated 52 HIV infected subjects, with an up to a 5 times higher vaccine dose, com-pared to our smallpox vaccine IMVAMUNE™. This obviously provides extremely encouraging data that IMVAMUNE™ is safe in population(s) in which conventional smallpox vaccines are strictly contraindicated.
Peter Wulff, President & CEO, Bavarian Nordic, stated: "The fact that we have already completed a trial with IMVAMUNE™ in subjects with atopic dermatitis and now are commencing our second trial with IMVAMUNE™ in an HIV infected population demonstrates again that Bavarian Nordic has the furthest advanced clinical development programme for a third generation smallpox vaccine".
