Tuberculosis Clinical Trial
Official title:
Efficacy and Safety of Immunomodulator (Mycobacterium w.) as an Adjunct Therapy in Category I Pulmonary Tuberculosis and Along With Assessment of Immunological Parameters
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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