Bavarian Nordic A/S reports preliminary safety and immunogenicity data from Phase II study with IMVAMUNE®. Vaccine is shown equally immunogenic in HIV-infected and healthy subjects.
Bavarian Nordic A/S announced today preliminary results from a Phase II study with IMVAMUNE® in HIV infected subjects in the company’s development programme for IMVAMUNE® as a safe third-generation MVA smallpox vaccine.
The completed Phase II study compared the safety and immunogenicity of IMVAMUNE® in 91 HIV infected subjects (CD4 > 350 cells/µl) to 60 healthy subjects. The study demonstrated that IMVAMUNE® is as equally well tolerated in HIV infected and healthy subjects. Importantly, the immunogenicity data also revealed that 96% of HIV infected subjects previously not vaccinated against smallpox (“vaccinia naïve”) had a detectable antibody response two weeks after the IMVAMUNE® boost vaccination, which turned out to be equivalent to the healthy control group. These data not only confirm the safety of IMVAMUNE®, but provide the first clear evidence that this vaccine is as equally immunogenic in these HIV infected subjects as healthy subjects.
Detailed data from this study will be presented at the 5th Annual ASM Biodefense Meeting, Washington, DC, 27 February - 2 March 2007.
