Enrolment of the first infant in VPM 1002, a phase 2 clinical trial of a new vaccine to prevent tuberculosis (TB) has successfully started at the South African Tuberculosis Vaccine Initiative (SATVI) with the first participant being vaccinated on Tuesday 25 August 2015.
According to Dr Angeliqua Luabeya, Principal Investigator, this is the most advanced new TB vaccine in clinical development, and if successful will help curtail the burden of the life-threatening TB disease in children, not only in endemic countries, but world wide. This trial is being supported by Serum Institute of India Ltd. (SIIL), and partly by TBVI.
The new vaccine VPM1002 was co-developed by scientists from TBVI partners Max Planck Society and the Hanover-based VPM, a spin-off company from the Helmholtz Centre for Infection Research (HZI). VPM1002 was modeled on an earlier TB vaccine called BCG – short for Bacillus Calmette–Guérin – that was first introduced in 1921, and since then has been given to millions of infants each year where TB is prevalent. What makes VPM1002 unique when compared with BCG is the fact that targeted genetic modifications might make the vaccine more effective in preventing TB. A series of studies in animal models, and two separate phase I clinical trials in adults and one phase 2a clinical trial in newborn infants, have already confirmed safety and have shown strengthening of the immune system against TB, thus raising hope for higher efficacy.
“Already during the phase I clinical trials in Europe and Africa, the new vaccine showed better tolerance and triggered a more targeted immune response than classical BCG. These promising findings were confirmed in a subsequent phase 2a trial in newborns, our ultimate target group,” confirms Mr. Adar C. Poonawalla, CEO and Executive Director of SIIL. “And now, enrolling the first infant in the current phase 2 clinical trial in HIV-exposed infants, that is, infants who need a safer and better vaccine the most, is a huge success. It brings us one important step closer to including the new vaccine in a global plan of action against TB by the end of this decade.”
Source and photo credit: SATVI