Efficacy and Safety of Immunomodulator as an Adjunct Therapy in New Pulmonary Tuberculosis(Category I) Patients.

NCT00341328 | Completed Phase 3 DMC

• 2 other identifiers: CR-01C-1/2003-10BT/PR7894/Med/14/1175/2006
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Tuberculosis

Keywords

India; Pulmonary Tuberculosis; Category-I Pulmonary Tuberculosis; Immunomodulator; Mycobacterium w

Outcome Measures

Primary Outcomes (4)

• The time of sputum conversion as well as the early sputum conversion between the two groups will be evaluated.

  from the baseline(visit 2)

• The cure rate will be evaluated as the primary parameter of efficacy.

  6-7 month

• The relapse in patients of category-I pulmonary TB will be compared in both the groups.

  at an interval of 6,12,18 and 24 months after the completion of the therapy

• Recording of any clinical adverse reactions for assessment of safety.

  at anytime during the study

Secondary Outcomes (1)

• An additional secondary efficacy endpoint is the patient's and physicians's global assessment of the clinical cure.

  6-7 month

Study Arms (2)

1

EXPERIMENTAL

In one arm the patient will receive intradermal Mycobacterium W Vaccine along with Category I ATT drugs according to RNTCP guidelines

Biological: Intradermal injection of Mycobacterium w

2

PLACEBO COMPARATOR

In this Arm patient will receive Placebo along with Category I ATT drugs according to RNTCP guidelines

Biological: Intradermal injection of Mycobacterium w

Interventions

Intradermal injection of Mycobacterium w BIOLOGICAL

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

Also known as: Immuvac

1; 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of either sex aged between 18 to 60 yrs.
• Newly diagnosed sputum positive pulmonary TB cases with at least 2 sputum samples that are positive on sputum microscopy (Negative, Scanty, Scanty may be enrolled.
• Patients who are willing to give an informed consent.

You may not qualify if:

• Known hypersensitivity to Category I anti-TB drugs on history at the time of Screening.
• Known history of DR-TB (includes MDR-TB and XDR-TB) at the time of screening. Patients with Mtb isolate resistant to one or more drugs are to be excluded.
• Presence of secondary immunodeficiency states: HIV, organ transplantation, diabetes mellitus, malignancy, treatment with corticosteroids (illicited on detailed history and lab investigations).
• Hepatitis B and C positivity.
• Patients with known extrapulmonary TB and/or patients requiring surgical intervention.
• Currently receiving cytotoxic therapy, or have received it within the last 3 months- Ask on History.
• Pregnancy and lactation on history.
• Patients with a known seizure disorder on history.
• Patients with known symptomatic cardiac disease, such as arrhythmias or coronary artery disease on history.
• Patients with abnormal renal function (Serum creatinine more than 1.5 or proteinuria more than 2+ )
• Patients with abnormal hepatic functions (bilirubin = 1.5 mg/dl; AST, ALT, SAP more than 1.5 x ULN; PT = 1.3x control)
• Patients with hematological abnormalities (WBC lesser than or equal to 3000/mm3; platelets less than or equal to 100,000/mm3).
• Seriously ill and moribund patients with complications:
• low lung reserve, marked tachypnoea, chronic cor pulmonale, congestive cardiac failure, BMI\<15,
• severe hypoalbuminemia (\< 2.5 g/dl).

Sponsors & Collaborators

• Ministry of Science and Technology, India: lead

Study Sites (2)

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Central JALMA Institute of Leprosy and Other Mycobacterial Diseases

Agra, 282001, India

Location

Related Publications (10)

• Patel N, Trapathi SB. Improved cure rates in pulmonary tuberculosis category II (retreatment) with mycobacterium w. J Indian Med Assoc. 2003 Nov;101(11):680, 682.

  PMID: 15198421 BACKGROUND

• Patel N, Deshpande MM, Shah M. Effect of an immunomodulator containing Mycobacterium w on sputum conversion in pulmonary tuberculosis. J Indian Med Assoc. 2002 Mar;100(3):191-3.

  PMID: 12408283 BACKGROUND

• Katoch K, Katoch VM, Natrajan M, Bhatia AS, Sreevatsa, Gupta UD, Sharma VD, Shivannavar CT, Patil MA, Bharadwaj VP. Treatment of bacilliferous BL/LL cases with combined chemotherapy and immunotherapy. Int J Lepr Other Mycobact Dis. 1995 Jun;63(2):202-12.

  PMID: 7602215 BACKGROUND

• Sharma P, Mukherjee R, Talwar GP, Sarathchandra KG, Walia R, Parida SK, Pandey RM, Rani R, Kar H, Mukherjee A, Katoch K, Benara SK, Singh T, Singh P. Immunoprophylactic effects of the anti-leprosy Mw vaccine in household contacts of leprosy patients: clinical field trials with a follow up of 8-10 years. Lepr Rev. 2005 Jun;76(2):127-43.

  PMID: 16038246 BACKGROUND

• Sharma P, Kar HK, Misra RS, Mukherjee A, Kaur H, Mukherjee R, Rani R. Disabilities in multibacillary leprosy following multidrug therapy with and without immunotherapy with Mycobacterium w antileprosy vaccine. Int J Lepr Other Mycobact Dis. 1999 Sep;67(3):250-8.

  PMID: 10575404 BACKGROUND

• Sharma P, Kar HK, Misra RS, Mukherjee A, Kaur H, Mukherjee R, Rani R. Reactional states and neuritis in multibacillary leprosy patients following MDT with/without immunotherapy with Mycobacterium w antileprosy vaccine. Lepr Rev. 2000 Jun;71(2):193-205. doi: 10.5935/0305-7518.20000021.

  PMID: 10920614 BACKGROUND

• Sharma P, Misra RS, Kar HK, Mukherjee A, Poricha D, Kaur H, Mukherjee R, Rani R. Mycobacterium w vaccine, a useful adjuvant to multidrug therapy in multibacillary leprosy: a report on hospital based immunotherapeutic clinical trials with a follow-up of 1-7 years after treatment. Lepr Rev. 2000 Jun;71(2):179-92. doi: 10.5935/0305-7518.20000020.

  PMID: 10920613 BACKGROUND

• Sharma P, Kar HK, Misra RS, Mukherjee A, Kaur H, Mukherjee R, Rani R. Induction of lepromin positivity following immuno-chemotherapy with Mycobacterium w vaccine and multidrug therapy and its impact on bacteriological clearance in multibacillary leprosy: report on a hospital-based clinical trial with the candidate antileprosy vaccine. Int J Lepr Other Mycobact Dis. 1999 Sep;67(3):259-69.

  PMID: 10575405 BACKGROUND

• Sharma SK, Mitra DK, Balamurugan A, Pandey RM, Mehra NK. Cytokine polarization in miliary and pleural tuberculosis. J Clin Immunol. 2002 Nov;22(6):345-52. doi: 10.1023/a:1020604331886.

  PMID: 12462334 BACKGROUND

• Khatri GR, Frieden TR. Controlling tuberculosis in India. N Engl J Med. 2002 Oct 31;347(18):1420-5. doi: 10.1056/NEJMsa020098.

  PMID: 12409545 BACKGROUND

MeSH Terms

Conditions

Tuberculosis; Tuberculosis, Pulmonary

Interventions

Immuvac

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Surendra K Sharma, MD, Ph.D.

  Professor and Head,Department of Medicine, AIIMS, New Delhi-110029

  STUDY CHAIR

• Bindu Dey, Ph.D.

  Department of Biotechnology, MST, GOI

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head

Study Record Dates

• First Submitted: June 20, 2006
• First Posted: June 21, 2006
• Study Start: March 1, 2007
• Primary Completion: October 1, 2011
• Study Completion: March 1, 2012
• Last Updated: April 26, 2013

Record last verified: 2013-04

Locations

IN (2)