Scientists have achieved a major breakthrough in the new TB vaccine, which is completely safe for both children and adults.

News Topical, Digital Desk : India is continuing efforts to defeat the serious disease tuberculosis. In this context, a large-scale trial of two new TB vaccines—VPM1002 and IMMUVAC—has been conducted.

The results of this phase-3 clinical trial, published in 'The British Medical Journal', show that both these vaccines are safe for children and adults, but they cannot provide complete protection against all forms of TB.

What is the 'PreventTB' test?

The test has been conducted by researchers at the Delhi-based Indian Council of Medical Research (ICMR) with the aim of reducing TB cases.

• The trial took place between July 2019 and December 2020 at 18 different locations in 6 states and union territories, including Delhi, Maharashtra and Tamil Nadu.
• The trial included more than 12,700 people aged 6 years or older living in the homes of TB patients.
• People were randomly assigned to receive a dose of VPM1002, Immuvac, or a placebo (4,239 people in each group). A second dose was given one month later to 11,829 people and they were followed for approximately 38 months. A total of 96.7 percent (12,295) completed the trial.

Why was a new vaccine needed?

Currently, in India, newborns are given the BCG vaccine at birth to protect them from TB . According to researchers, this vaccine protects young children against severe forms of TB, but is not very effective for adolescents and adults. New vaccines are being tested to address this shortcoming.

Special things about the new vaccine

• VPM1002: This is a recombinant vaccine created using genetic engineering. It was developed by the German pharmaceutical company Serum Life Sciences Europe GmbH.
• IMMUVAC: This is an inactivated vaccine made from a non-infectious form of the pathogen. It was jointly developed by ICMR and Ahmedabad-based Cadila Pharmaceuticals.

What were the final results of the trial?

This Phase 3 trial is the final stage of evaluating the safety and effectiveness of any new treatment. Results have been mixed:

• Safety and Immunity: Both vaccines were found to be completely safe for adults and children and also produced a good immune response in the body.
• Where was the disappointment: Testing found that both vaccines were not successful in completely preventing lung TB or all types of infections caused by TB microorganisms.

Where did you get the big success?

TB that occurs in other parts of the body outside the lungs is called 'extrapulmonary TB' , in which the risk of death is higher than that of pulmonary TB.

• The vaccine demonstrated 50.4% efficacy against extrapulmonary TB in all age groups, including adults aged 36 to 60. Furthermore, it protected against all forms of TB (pulmonary and extrapulmonary) in children aged 6 to 14 years.
• This vaccine provided protection against extrapulmonary TB only in children aged 6 to 10 years.

While these new vaccines may not be 100% effective in preventing all forms of TB, the 50.4% protection shown by 'VPM 1002' against extrapulmonary TB (TB with a high mortality rate) is considered a very important and potentially beneficial step in the field of public health.

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