BHUBANESWAR : In a significant breakthrough, the Institute of Life Sciences (ILS), Bhubaneswar has developed a next-generation subunit vaccine for tuberculosis (TB). The vaccine named ‘Hsp16.3C4’ developed in collaboration with IIT-Bhubaneswar is ready for technology transfer after successful pre-clinical trials.
TB remains one of the world’s deadliest infectious diseases, claiming over 12 lakh lives last year alone. Currently Bacillus Calmette Guérin (BCG) vaccine remains the sole licensed immunisation strategy in use for TB prevention across all countries. The collaborative research led by senior scientist of ILS Dr Sunil Kumar Raghav and Prof Ashis Biswas of IIT-Bhubaneswar led to the development of the HSP subunit vaccine, considered to be the first vaccine against TB from India.
Although BCG provides modest protection to infants, it has failed to provide complete protection due to limited efficacy, variable protective outcomes and lack of durable memory responses. It fails to even prevent pulmonary TB, the most infectious form of the disease, in adolescents and adults.
Research to bridge the gap and develop a vaccine for all age-groups has been the focus for decades. The pre-clinical trials conducted on mice models have been successful as no toxicity signals were observed with normal biochemical parameters such as blood glucose, renal functional markers (urea and creatinine) and lipid profile components (cholesterol and triglycerides) recorded post-vaccination.
Researchers in the study conducted to ascertain the efficacy claimed that the vaccine was not produced by the BCG strain, making it a uniquely specific Mtb antigen (protein from the bacterium Mycobacterium tuberculosis ) that does not interfere with BCG biology.
One of the most promising findings of the study “Hsp16.3C4, a C-terminal truncated mutant, confers strong cellular and humoral immunity against pulmonary tuberculosis” published recently was the synergistic effect of co-administering the new vaccine with the BCG vaccine.
The researchers believe the new vaccine could be used both as a stand-alone immunisation and as a booster or co-administration strategy alongside BCG in infants, adolescents and adults.