During 2006 and 2007, Bavarian Nordic has made significant progress in the IMVAMUNE® development programme. The company has 9 completed or on-going clinical studies and has vaccinated more than 1,600 persons with IMVAMUNE®.
Bavarian Nordic is the only company having clinically tested an MVA-based smallpox vaccine in people that are contraindicated to traditional smallpox vaccines, (e.g. DryVax®), which include those diagnosed with atopic dermatitis or HIV.
In November 2007, Bavarian Nordic reported the successful completion of a Phase II trial in 745 healthy subjects who received either one or two doses of IMVAMUNE® or placebo. The large amount of safety data collected from 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 serious cardiac events (e.g. cases of myo-/pericarditis) similar to those reported for traditional smallpox vaccines. Moreover, vaccinations with IMVAMUNE® resulted in 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 who had in the past 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 2009.
In February, Bavarian Nordic reported the first safety and immunogenicity data of an MVA-based smallpox vaccine in HIV-infected subjects. The data represented a landmark in the development of IMVAMUNE®, as the trial in 151 people demonstrated that IMVAMUNE® was not only well tolerated, but was as immunogenic in HIV-infected subjects as in healthy people.
Bavarian Nordic has two ongoing Phase II studies in immunocompromised subjects. In the US, a multicentre study is currently ongoing in HIV-infected subjects. The main part of the study is expected to be completed in 2008, and the safety data will be included in the data package for submission to the FDA to support the potential use of IMVAMUNE® in a declared emergency.
The other ongoing Phase II study in immunocompromised subjects is part of the RFP-2 contract extension.
RFP-2 contract extended
In 2007, the US Government extended the RFP-2 contract that was awarded to Bavarian Nordic in 2004. Within the scope of the extension, Bavarian Nordic is performing a larger Phase II study in Mexico and the USA investigating the safety and immunogenicity of IMVAMUNE® in people diagnosed with atopic dermatitis (AD). This is an important population, because people with a history of or active AD are excluded from vaccination with traditional smallpox vaccines due to the problematic safety profile of these vaccines. The study is expected to be completed in the second half of 2009.
Scientific Articles on this topic:
Safety and immunogenicity of IMVAMUNE, a promising candidate as a third generation smallpox vaccine
Modified vaccinia virus Ankara protects macaques against respiratory challenge with monkeypox virus
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