Bavarian Nordic A/S provides update on its MVA nef programme against HIV
Bavarian Nordic A/S announced today preliminary data from an ongoing Phase II study with its MVA nef vaccine candidate against HIV. The final data, which are expected early 2007, will be independently reviewed by leading HIV physicians and regulatory experts in Bavarian Nordic’s Scientific Advisory Board. Accordingly Bavarian Nordic will initiate discussions with the authorities in order to determine the future development plan for the vaccine.
The Phase II study comprised a comparison of three groups of HIV infected subjects who received a high dose MVA nef (5*10E8), a low dose MVA nef (10E8), or IMVAMUNE® (10E8) as a control. Two weeks after the thirdvaccination, 37 subjects volunteered to interrupt their antiretroviral therapy (HAART), which allowed the potential efficacy of MVA nef to control HIV replication to be investigated. Among the subjects that interrupted HAART there was a clear dose dependent related trend that those subjects vaccinated with MVA nef had a lower HIV count compared to the subjects vaccinated with IMVAMUNE®. These subjects will continously be monitored to see whether the beneficial effects of MVA nef continue and become even more pronounced in the absence of HAART compared to the control group whom received IMVAMUNE®.