Bharat Biotech’s TB vaccine candidate on the verge of entering phase-III trials

Bharat Biotech’s TB vaccine candidate on the verge of entering phase-III trials

Subject: Science and technology

Section: Biotechnology

Context:  A new Tuberculosis (TB) vaccine candidate of Bharat Biotech International is on the verge of entering phase III clinical trials.

Details:

• Two separate Phase II trials of Mycobacterium Tuberculosis Vaccine (MTBVAC) of Bharat Biotech have been completed,
• With the completion of phase II trials, Bharat Biotech is now planning to take up Phase II safety/immunogenicity study of the vaccine in people living with HIV (PWHIV) The phase III trials of it will follow.
• Of the two trials, one was supported by The European & Developing Countries Clinical Trials Partnership (EDCTP)and was sponsored by Biofabri in infants in South Africa, while the other was sponsored by International AIDS Vaccine Initiative (IAVI) and supported by the US National Institutes of Health and the US Department of Defence through its Congressionally Directed Medical Research Program
• TB infects more than 20 per cent of the global population and is the second leading cause of deaths from infectious disease after Covid19. TB is a highly contagious disease where vaccines are seen as the ‘best’ solution to prevent disease, reduce transmission and combat multi-drug resistant strains.
• If successful, the collaboration between Bharat Biotech and Biofabri (which was announced last year) is expected to result in the worldwide production and the supply of the future vaccine in more than 70 countries with a high TB incidence, such as India, country with the highest TB burden in the world, with a 25 per cent of all cases.
• “MTBVAC is being developed for two purposes – as a more effective vaccine than Bacille Calmette-Guerin (BCG) for newborns and for the prevention of TB disease in adults and adolescents, for whom there is currently no effective vaccine. It has a unique feature of preventing transmission or spread of the disease
• MTBVAC is being seen by the industry is one of the `promising’ vaccine candidates in the current global TB vaccine pipeline.
• The only currently available TB vaccine, the Bacillus Calmette-Guérin vaccine (BCG), was developed 100 years ago and has limited efficacy in preventing pulmonary TB in adults, who, along with adolescents, are the biggest spreaders of the disease.
• Apart from Bharat Biotech’s Mycobacterium Tuberculosis Vaccine, currently there is only one vaccine candidate developed by GSK along with Aeras and the International AIDS Vaccine Initiative (IAVI)- M72- is likely to enter phase III trials in 2024
• The development of new medicines and medical practices is at the forefront of medical research, with researchers endeavouring to find the best thing or way to manage or treat various conditions and diseases. Clinical trials are at the core of this process, especially when humans are the designated recipients of such innovation. These trials ensure that any medicine, surgical method, or, more broadly, an intervention is safe, well-tolerated, and efficacious.
• Simply speaking, in a clinical trial, investigators enrol participants who meet certain qualifying criteria, then administer the intervention being tested, and finally measure the outcomes – all according to a predetermined plan.
• Trials can test drugs, medical devices, and even procedures. They may compare a course of treatment to existing regimens or a placebo; they may be blinded or double-blinded; in fact, there are several types of clinical trials depending on the investigators’ needs.
• A clinical trial is a systematic study to generate data for discovering or verifying the clinical and pharmacological profile (including pharmacodynamic and pharmacokinetic) or adverse effects of a new drug on humans.
• It is the only way of establishing the safety and efficacy of any drug before its introduction in the market for human use and is preceded by animal trials where the efficacy and side effects are observed in animals and an estimated drug dose is established.

Phases of Clinical Trials

• Clinical trials are carried out in four phases. Clinical trials of drugs developed in India have to undergo all four phases of trials in India.
• Phase I or clinical pharmacology trials or “first in man” study: This is the first time where the new drug is administered to a small number, a minimum of 2 healthy, informed volunteers for each dose under the close supervision of a doctor. The purpose is to determine whether the new compound is tolerated by the patient’s body and behaves in the predicted way.
• Phase II or exploratory trials: During this phase, the medicine is administered to a group of approximately 10-12 informed patients in 3 to 4 centers to determine its effect and also to check for any unacceptable side effects.
• Phase III or confirmatory trials: Purpose is to obtain sufficient evidence about the efficacy and safety of the drug in a larger number of patients, generally in comparison with a standard drug and/or a placebo as appropriate. In this phase, the group is between 1000-3000 subjects. If the results are favorable, the data is presented to the licensing authorities for a commercial license to market the drug for use by the patient population for the specified and approved indication.
• Phase IV trials or post-marketing phase: Phase of surveillance after the medicine is made available to doctors, who start prescribing it. The effects are monitored on thousands of patients to help identify any unforeseen side effects.

Regulatory Mechanism in India

• Clinical trials in India are governed by the acts:
  • Drugs and Cosmetics Act, 1940,
  • Medical Council of India Act, 1956 and
  • Central Council for Indian Medicine Act, 1970.
• Prerequisites of conducting a clinical trial in India are:
  • Permission from the Drugs Controller General, India (DCGI)
  • Approval from respective Ethics Committee where the study is planned
  • Mandatory registration on the ICMR maintained website.

Clinical trials also have phases. Vaccines developed against SARS-CoV-2 had to go through four. (Because vaccines are given to healthy people, they need to be tested more than drugs that are given to people who are ill.) Each phase was based on the trial’s objective, number of participants, and some other characteristics.

In India, the Indian Council of Medical Research maintains an online public-record system called the Clinical Trials Registry-India. All clinical trials in India are required to register themselves here.

• In a clinical trial, investigators enrol participants who meet certain qualifying criteria, then administer the intervention being tested, and finally measure the outcomes – all according to a predetermined plan.
• Trials can test drugs, medical devices, and even procedures. They may compare a course of treatment to existing regimens or a placebo; they may be blinded or double-blinded; in fact, there are several types of clinical trials depending on the investigators’ needs.
• In India, the Indian Council of Medical Research maintains an online public-record system called the Clinical Trials Registry-India. All clinical trials in India are required to register themselves here.