Tuberculosis Elimination Strategy

Clinical Trials for MTBVAC Tuberculosis Vaccine in India

Note4Students

From UPSC perspective, the following things are important :

Prelims level: MTBVAC, TB, DOTS Regimen, Nikshay Poshan Yojana

Mains level: NA

What is the news?

  • Bharat Biotech, in collaboration with Spanish biopharmaceutical company Biofabri, has initiated clinical trials for the Mycobacterium Tuberculosis Vaccine (MTBVAC) in India, marking a significant milestone in TB vaccine development.
  • The only currently available TB vaccine, the Bacillus Calmette-Guérin vaccine (BCG), was developed 100 years ago and is less effective.

About MTBVAC

  • MTBVAC is a unique TB vaccine based on a genetically modified form of Mycobacterium tuberculosis, containing all antigens present in human-infecting strains, unlike the BCG vaccine.
  • It is developed in the laboratory of the University of Zaragoza with contributions from Dr. Brigitte Gicquel of the Pasteur Institute, Paris.
  • MTBVAC is designed to offer superior and potentially longer-lasting protection compared to the BCG vaccine, particularly for newborns and in preventing TB in adults and adolescents.

Objectives of Clinical Trials in India

  • Safety and Immunogenicity: The ongoing trials in India aim to evaluate the safety and immunogenicity of MTBVAC, with plans for a pivotal Phase 3 trial in 2025.
  • Population Significance: Studying the vaccine’s efficacy in India, with its high TB burden, is crucial for advancing TB vaccine research and addressing the global TB epidemic.

What is Tuberculosis?

  • Tuberculosis is an infection caused by Mycobacterium tuberculosis.
  • Robert Koch discovered Mycobacterium tuberculosis which causes TB, and his discovery opened the way towards diagnosing and curing this disease.
  • It can practically affect any organ of the body.
  • The most common ones are lungs, pleura (lining around the lungs), lymph nodes, intestines, spine, and brain.

Transmission:

It is an airborne infection that spreads through close contact with the infected, especially in densely populated spaces with poor ventilation.

Symptoms:

Common symptoms of active lung TB are cough with sputum and blood at times, chest pains, weakness, weight loss, fever and night sweats.

Treatment Facilities in India:

  • DOTS (Directly Observed Treatment, Short-Course) regimen: It is the recommended treatment approach for TB by the WHO. Patients receive a combination of four antibiotics: isoniazid, rifampicin, pyrazinamide, and ethambutol. These drugs are usually administered daily for the first two months of treatment, followed by a continuation phase with isoniazid and rifampicin for an additional four to seven months.
  • Nikshay Poshan Yojana (2018): It was launched to support every Tuberculosis (TB) Patient by providing a Direct Benefit Transfer (DBT) of Rs 500 per month for nutritional needs.

Issues in TB Treatment: Drug Resistance

Drug resistance emerges when anti-TB medicines are used inappropriately, through incorrect prescription by health care providers, poor quality drugs, and patients stopping treatment prematurely.

  1. Multidrug-resistant tuberculosis (MDR-TB): Itis a form of TB caused by bacteria that do not respond to isoniazid and rifampicin, the 2 most powerful, first-line anti-TB drugs. MDR-TB is treatable and curable by using second-line drugs such as
  2. Extensively drug-resistant TB (XDR-TB): Itis a more serious form of MDR-TB caused by bacteria that do not respond to the most effective second-line anti-TB drugs, often leaving patients without any further treatment options.

 


PYQ:

2014: Can overuse and free availability of antibiotics without Doctor’s prescription, be contributors to the emergence of drug-resistant diseases in India? What are the available mechanisms for monitoring and control? Critically discuss the various issues involved.

 

Practice MCQ:

With reference to the Tuberculosis (TB), consider the following statements:

  1. TB is an infection caused by Mycobacterium tuberculosis.
  2. It only targets Lungs.
  3. Nikshay Poshan Yojana aims for TB support is essentially a Direct Benefit Transfer (DBT).

How many of the given statements is/are correct?

  1. One
  2. Two
  3. Three
  4. None

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