Efficacy and Safety Study of Immunomodulator as an Adjunct Therapy in Pulmonary Tuberculosis (TB) Retreatment Patients
Condition: Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to study the efficacy and safety of Mycobacterium in treating
      patients with lung tuberculosis . Mycobacterium is a strain of bacterium which is used as a
      vaccine and an adjuvant drug against leprosy. This agent has also been found to be effective
      in the treatment of lung tuberculosis in a limited number of patients.

      The researchers are conducting this study in the World Health Organization (WHO) category-II
      of lung tuberculosis patients to see the efficacy and also to see any change in immunological
      parameters.
    

Detailed description: 
      Mycobacterium w is a recently introduced immunomodulator, which has been found to be useful
      in rapid killing of Mycobacterium leprae. It improves the clearance of Mycobacterium leprae
      from the body and is thereby useful in reducing the duration of therapy significantly for
      multibacillary leprosy. Mycobacterium w shares an antigen with both Mycobacterium leprae as
      well as Mycobacterium tuberculosis. Mycobacterium w is also found to be useful in the
      prevention of tuberculosis in experimental animals.

      Previous studies on the efficacy of Mycobacterium w as an immunomodulator in pulmonary
      tuberculosis patients have shown higher sputum conversion rates in patients given
      Mycobacterium w as an adjuvant therapy along with standard anti-tuberculosis treatment. It
      has faster and remarkable sputum converting capacity. Similar studies conducted in pulmonary
      TB category -II [re-treatment as per Revised National Tuberculosis Control Programme (RNTCP),
      Govt. of India] patients have shown improved cure rates.

      Mycobacterium w is commercially available under the brand name of "Immuvac" injection in 0.5
      ml multi dose vials approved for use as immunomodulator against Mycobacterium leprae in
      patients with leprosy. Each vial has 0.5 x 10^9 heat-killed bacilli in a buffered solution.
      It is manufactured by Cadila Pharmaceuticals Ltd.; Ahmedabad, Gujarat-382 210, India. In this
      clinical trial one dose consists of 0.1 ml given as an intradermal injection, which contains
      10^9 bacilli. A total of 6 doses are given during the Intensive Phase (as per RNTCP, Govt. of
      India) of treatment. Two injections on both upper arms on day-0 and subsequently one
      injection on days 14, 28, 42 and 56. No injections are given during the Continuation Phase
      (as per RNTCP, Govt. of India) of treatment.

      As of now, it is not commercially available for use in TB patients as an immunomodulator.
      Therefore, the investigators are investigating Mycobacterium w (Mw) for its efficacy in TB
      patients in a "double-blind placebo-controlled randomized clinical control trial" fashion. We
      are conducting this trial in Category-II pulmonary TB patients (as per RNTCP, Govt. of
      India), and are assessing the outcome in the form of clinical improvement, sputum conversion
      and immunological parameters. This is a multi-centric trial sponsored by the Department of
      Biotechnology, Ministry of Science and Technology, Govt. of India and Cadila Pharmaceuticals
      Ltd., India.
    

Intervention name(s): Intra-dermal administration of Mycobacterium w
Intervention type(s): Biological
Intervention description(s): Mw Vaccine is given as oral suspension. Total 6 doses are given 0.2 ml at baseline and then 0.1 ml after interval of 2 weeks upto 8 weeks
Other intervention name(s): Immuvac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: India; Pulmonary Tuberculosis; Category-II tuberculosis; Immunomodulator; Mycobacterium w; Revised National Tuberculosis Control Programme; Category-II Pulmonary Tuberculosis