The randomized, Active and Placebo Controlled, Phase IIa study to evaluate safety, immunogenicity and Prevention of Infection with Mycobacterium tuberculosis after vaccination with the following vaccine candidates in high risk group population (contacts of TB patients) is being planned. The proposed timeline for this trial is 5-years.
VPM1002: VPM1002 is a live recombinant form of BCG developed by Vakzine Projekt Management in Germany and licensed to the Serum Institute of India (SII). It is currently being tested in a Phase IIa trial in over 400 South African newborns. The study is designed to compare the safety and immunogenicity of VPM1002 versus BCG in both HIV-exposed and unexposed infants.APhaseIIbstudy [BCG-replacement trial in newborns (pending a favorable outcome from the South African study)]and Phase III prevention-of recurrence trial in adultsfor VPM 1002 are currently being discussed with regulatory authorities in India by SII.
M72/AS01: The M72 + AS01E vaccine candidate is being developed by GlaxoSmithKline, a leading global healthcare company. The vaccine comprises an immunogenic fusion protein (M72) derived from two M. tuberculosis antigens (MTB32A and MTB39A), identified in human and animal studies over a 20-year period, and the GSK proprietary adjuvant AS01E. . In preclinical settings, M72 formulated with AS01E has proven effective for mobilizing immune cells and effectors that are believed to play a key role in protecting against tuberculosis. M72/AS01 has been proven to be efficacious in a number of PhaseI/II multi-country trials. Currently, it is in two separate Phase II clinical trials being held in South Africa and Belgium in adult population.
