Bavarian Nordic A/S - Interim Report for the Period 1 January to 30...(safety and immunogenicity study in 15 HI...)

The MVA-BN(R) HIV multiantigen vaccine encodes eight genes from HIV, including Nef and thus represents a more advanced vaccine candidate compared to Bavarian Nordic's previous MVA-based HIV vaccine candidates, MVA HIV nef and MVA-BN(R) HIV polytope. In previous clinical studies with MVA HIV nef, Bavarian Nordic has demonstrated proof of concept for the MVA technology's ability to control HIV replication. Furthermore the vaccine was shown to be immunogenic and to induce a broad T-cell response to Nef. The MVA-BN(R) HIV multiantigen builds on these positive results and thus represents an excellent opportunity to stimulate a broad immune response to the majority of the HIV proteins that will likely have important implications in a prophylactic and therapeutic setting for HIV.

Childhood vaccines (measles and RSV)

Bavarian Nordic has previously shown that IMVAMUNE(R) and MVA-BN(R) based vaccines (including the measles vaccine candidate) are safe and highly immunogenic in new born animals. These findings offer the opportunity to develop MVA-BN(R) as a platform vaccine technology for childhood vaccines that have the potential to stimulate protective immune responses in children under the age of 1 year.

The first Phase I study that was initiated late in 2007 evaluated the safety and immunogenicity of the measles vaccine in 30 healthy adult subjects. This is the first study to support the development of an RSV vaccine. The immunogenicity data from this study have revealed that the vaccine is highly immunogenic. As expected, the majority (93%) of the enrolled subjects already had measurable antibodies against measles, due either to prior vaccination or measles infection. However, following the f
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