Efficacy and Safety Study of Immunomodulator as an Adjunct Therapy in Pulmonary Tuberculosis (TB) Retreatment Patients

NCT00265226 | Completed Phase 3 DMC

• 2 other identifiers: CR-01A/2003-10NI-705
• Study Type: interventional
• Target: 1,020
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Tuberculosis

Keywords

India; Pulmonary Tuberculosis; Category-II tuberculosis; Immunomodulator; Mycobacterium w; Revised National Tuberculosis Control Programme; Category-II Pulmonary Tuberculosis

Outcome Measures

Primary Outcomes (4)

• The time of sputum conversion as well as the early sputum conversion between the 2 groups will be evaluated.

  from baseline (visit 2)

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

  8-9 months

• The relapse in patients of category II tuberculosis 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 at anytime during the study for assessment of safety

  2-8 weeks

Secondary Outcomes (1)

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

  8-9 months

Study Arms (2)

1

EXPERIMENTAL

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

Biological: Intra-dermal administration of Mycobacterium w

2

PLACEBO COMPARATOR

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

Biological: Intra-dermal administration of Mycobacterium w

Interventions

Intra-dermal administration of Mycobacterium w BIOLOGICAL

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

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 who are sputum positive for pulmonary tuberculosis and who have been treated previously for more than 1 month as per the RNTCP/WHO guidelines.
• Patients who are willing to give written informed consent.

You may not qualify if:

• Patients who are known to be hypersensitive to those ATTs being administered.
• Patients co-infected with HIV, hepatitis B or hepatitis C.
• Pregnant and lactating females or females of child bearing age with a urine HCG positive result 24-48 hours prior to every injection of Mw till 8 weeks.
• Patients with abnormal renal function, liver function or hematological tests.
• Seriously ill and moribund patients with complications such as low lung reserve, marked tachypnoea, chronic cor pulmonale, congestive heart failure.
• Severely malnourished patients with body mass index (BMI) \< 15
• Severe hypoalbuminemia.

Sponsors & Collaborators

• Ministry of Science and Technology, India: lead

Study Sites (8)

Mahavir Hospital

Hyderabad, Andhra Pradesh, 500004, India

Location

Smt NHL Municipal Medical College & B.J. Medical College

Ahmedabad, Gujarat, 380006, India

Location

National Tuberculosis Institute

Bangalore, Karnataka, 560 003, India

Location

All India Institute of Medical Sciences

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

Location

Lala Ram Swarup Institute of Tuberculosis and Respiratory Diseases

New Delhi, National Capital Territory of Delhi, 110030, India

Location

SMS Medical College

Jaipur, Rajasthan, India

Location

Tuberculosis Research Centre

Chennai, Tamil Nadu, 600 031, India

Location

Central JALMA Institute of Leprosy

Agra, Uttar Pradesh, 282001, India

Location

Related Publications (9)

• 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. 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 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

• 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, M.D., Ph.D.

  Professor and Head, Department of Medicine, All India Institute of Medical Sciences, New Delhi, India

  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: December 13, 2005
• First Posted: December 14, 2005
• Study Start: March 1, 2005
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2011
• Last Updated: January 6, 2014

Record last verified: 2011-07

Locations

IN (8)