Serum Institute of India Pvt. Ltd. at Pune, will start a Phase II/III vaccine trial for tuberculosis using a novel recombinant BCG (bacillus Calmette-Guérin) vaccine in June this year. This new vaccine, VPM1002, is more powerful, efficacious and better recognized by the immune system.
A single dose of the vaccine will be administered to the adult volunteers and a follow up would be done for a year. The trial will be conducted in 15-17 centres across the country on adults who have been successfully treated and cured for TB.
The safety concerns of this vaccine have already been addressed in two Phase I trials in Germany in 2009 and South Africa in 2010, and in one Phase 2a trial in South Africa in 2012.
Trials conducted in newborn infants confirmed the safety and tolerance of the new vaccine. It has been observed that the currently used BCG vaccine causes BCG related disease in HIV- positive babies due to an immune-compromised system. This recombinant version is expected to be safe for babies exposed to HIV.
A Phase III trial of the new vaccine is being planned next year on newborns in India.