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

Summary: 
      The purpose of the study is to evaluate the efficacy and safety of Mycobacterium w in new
      lung tuberculosis patients. Mycobacterium w is a strain of bacterium which is being used as
      vaccine and adjunct drug against leprosy. This agent has also been found to be useful in the
      treatment of lung tuberculosis in limited number of patients.

      We are conducting this study in category-I patients( As per World Health Organization,Geneva
      classification of tuberculosis) having lung tuberculosis to see the efficacy and also to see
      any change in the 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 clearance of Mycobacterium leprae from
      body and is thereby useful in reducing duration of therapy significantly for multibacillary
      leprosy. Mycobacterium w shares antigens with Mycobacterium leprae as well as Mycobacterium
      tuberculosis. Mycobacterium w is also found to be useful in prevention of tuberculosis in
      experimental animals. Previous studies for efficacy of Mycobacterium w as immunomodulator in
      pulmonary tuberculosis patients have shown faster 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 500 million 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 intradermal injection, which contains 100
      million bacilli. A total of 6 doses are given during the Intensive Phase(as per
      RNTCP,Ministry of Health and Family Welfare,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,Ministry of Health and Family
      Welfare,Govt.of India)of treatment.

      As of now it is not commercially available for therapeutic use in TB patients as
      immunomodulator.Therefore we are investigating Mycobacterium w for its efficacy in TB
      patients in a "double-blind placebo-controlled randomized clinical control trial" fashion. We
      are conducting this trial in Category-I pulmonary TB Patients(as per RNTCP,Ministry of Health
      and Family Welfare,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): Intradermal injection of Mycobacterium w
Intervention type(s): Biological
Intervention description(s): Mw Vaccine is given as intradermal administration. 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-I Pulmonary Tuberculosis; Immunomodulator; Mycobacterium w