On July 15, 2019, Indian Council of Medical Research (ICMR) has launched a vaccine trial ('Trial') to prevent the occurrence of Tuberculosis (TB) among close contacts of TB patients. The main purpose of the trial is to prevent the spread of the disease among people in close contact with TB patients.1
Background of Tuberculosis in India:
India accounts for about a quarter load of the Tuberculosis around the globe with highest number of Multi Drug Resistance TB (MDR-TB) patients. Also, India is the second highest country after South Africa for HIV- TB coinfections. Moreover the lack of awareness, social stigma, limited availability of diagnosis and treatment is making Indian population vulnerable to TB infection. Therefore, there is a need that the health bodies should come with an easy vaccine option which is cost effective and can easily prevent the disease from spreading. ICMR conducted landscape analysis of the two potential vaccine candidates VPM 1002 and MIP and took forward the phase 3 clinical trial in healthy caretaker/attendees of sputum smear positive TB patients. The main purpose of the phase 3 trial was to evaluate the safety and tolerability of VPM1002 compared to BCG in newborn infants with TB.2
About the vaccines
VPM1002 is the recombinant bacille Calmette–Guerin (BCG) which is more effective in the treatment of tuberculosis. Bacillus Calmette-Guerin (BCG), an attenuated strain of Mycobacterium bovis was the only vaccine which has been used in treatment of tuberculosis in young children. However several TB cases are still observed in children after the use of BCG. The protective efficacy of BCG against pulmonary TB is even less certain and yet pulmonary TB comprises >75% of the disease burden. This was the major reason for the development of the more efficacious and safer drug for treating TB. VPM1002 vaccine was developed to enhance MHC-I-related immune responses. Moreover the drug was more safe and effective in comparison to the conventional BCG and can be given to adults for treatment of TB whereas BCG is only used in children.
Objective of the Trial
The vaccine trial for Tuberculosis was performed with two vaccines VPM 1002 produced by Serum Institute of India, Pune and MIP (Mycrobacterium Indicus Pranii). The aim of the trial was to evaluate the safety and efficacy of the above two vaccines in single trial against control group with no vaccine. The study enrolled 1200 healthy individuals in contact with smear positive TB cases that are at high risk of contracting the disease. These individuals were selected from 7 sites in 6 states (Delhi, Karnataka, Maharashtra, Orissa, Tamil Nadu and Telangana) of the country. The study has the approval from all the regulatory bodies of India.
Since TB is highly prevalent disease there is an imperative need that the health bodies and ministry should come up with a vaccine or treatment remedies which can prevent the disease effectively without any side effects. To achieve the goal ICMR has conducted the trial on various vaccines stains which have the potential to prevent the disease more effectively as compared to the conventional vaccine options.
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