Context

The Indian Council of Medical Research (ICMR) has started a vaccine trial to prevent tuberculosis (TB) among those living close to patients suffering from the disease.

About

More on news:

• The ICMR launched the third-phase trials for anti-Tuberculosis (TB) vaccine that could be administered to anybody aged six years and above.
• The clinical trial is aimed at preventing and decreasing the burden of TB in the country.
• The Phase III trial is the first-ever government conducted vaccine trial, which is being conducted to come up with the first TB vaccine for adults as the BCG vaccine is only for new-borns that was undertaken decades ago, it is poorly protective against pulmonary disease in adolescents and adults, and therefore at reducing Mycobacterium tuberculosis (Mtb) transmission.

Vaccine Trials by ICMR

• After a detailed analysis of two potential vaccines, VPM 1002, produced by Serum Institute of India, Pune, and MIP (Mycrobacterium Indicus Pranii) were shortlisted for phase III vaccine trials.
• This clinical trial will evaluate the safety and efficacy of these two vaccines in a single trial against control group (not suffering from the disease).
• The study would be done on patients’ contacts from seven sites: Delhi, Karnataka, Maharashtra, Odisha, Tamil Nadu and Telangana and it would enrol 12,000 healthy household contacts of a patient whose sputum has tested positive for TB and are therefore at high risk of contracting the disease.
• ICMR would pitch vaccines to be available at highly subsidised rates in the public sector as well.
• The study has the approval of all statutory regulatory bodies of India according to Indian regulatory guidelines.

What is TB?

• It is a contagious infection that usually attacks the lungs. It can also spread to other parts of the body, like the brain and spine. A type of bacteria called Mycobacterium tuberculosis causes it.

Status of TB

• In 2016, there were an estimated 10.4 million new TB cases worldwide.
• The WHO End TB Strategy aims at a 95 % reduction in TB mortality and a 90 % reduction in TB incidence worldwide by 2035.
• In India, an estimated 2.79 million patients were suffering from the disease in 2016, while 423,000 patients were estimated to have died during the year.
• India was also one of the major contributors to under-reporting and under-diagnosis of TB cases globally, according to the Global TB Report 2018.
• India aims to eliminate TB by 2025. While a whole range of drugs and diagnostics are being worked upon to achieve this aim, this vaccine shall play a pivotal role in that direction.

Purpose

• The ultimate goal is to develop a vaccine that can prevent active TB and be a part of large campaigns aimed at eliminating the disease.
• This clinical study in India could help achieve this goal and significantly advance the global fight against TB.

ICMR

• It is an apex body in India for the formulation, coordination and promotion of biomedical research.
• It is one of the oldest and largest medical research bodies in the world. The ICMR is funded by the Government of India through the Department of Health Research, Ministry of Health and Family Welfare.
• The council's research priorities coincide with National health priorities such as control and management of communicable diseases, fertility control, maternal and child health, control of nutritional disorders etc.
• These efforts are undertaken with a view to reduce the total burden of disease and to promote health and well-being of the population.

Steps taken by Government of India

• India has set a target for complete elimination of Tuberculosis (TB) by 2025, five years ahead of the global target of 2030.
• It launched TB Free India Campaign. Government is implementing a National Strategic Plan (NSP) to end TB by 2025 with funding of over Rs.12, 000 crore for the next three years to ensure every TB patient has access to quality diagnosis, treatment and support.
• Public-private partnership models and Information Technology (IT) tools have been used for monitoring the programme and treatment adherence.
• Community engagement is the hallmark and it is becoming a social movement to end TB in India.
• The new NSP adopts a multi-pronged approach which aims to detect all TB patients with an emphasis on reaching TB patients seeking care from private providers and undiagnosed TB in high-risk populations, treat all patients irrespective of where they seek care adopting a patient-centric approach, prevent emergence of TB in susceptible population groups and build empowered institutions and human resources to streamline implementation.
• Under the Revised National Tuberculosis Control Programme (RNTCP), the government has also proposed an incentive of Rs.500 per patient per month for the nutritional support of TB-affected patients during the course of the treatment.
• The states have the option for providing these incentives in cash or kind. The ministry has formulated the guidance document on nutritional care and support for TB patients which includes guidance on nutritional assessment, counselling and appropriate dietary advice.
• The programme is also facilitating the TB patients to avail various social support schemes of the state governments.
• NIKSHAY is a web based solution for monitoring of TB patients developed by National Informatics Centre (NIC). This is used by health functionaries at various levels across the country in association with Central TB Division (CTD), Ministry of Health & Family Welfare.