ANNUAL REPORT - Department of Biotechnology

advertisement in the following areas:
� Collection and storage of aliquots of specimen
i.e. sputum, serum, CSF, urine, tissue etc.
� Creation of centralized facilities and reagent
bank
� International level repository/depository of
Mycobacterium
� A central animal facility for breeding various
inbred and knockout strains Creation/ setting
up of a centralized vaccine/drug testing facility
� Creation/ setting up of a centralized validated
assay development facility
� Containment facilities
� Preparation of clinical trial site/s
� Human Resource Development
� Industrial Collaboration
While the focus of research remained on early
diagnosis and vaccine development, the department
entered into the area of drug development for
tuberculosis using proteomics, genomics and
bioinformatics approaches. About 90 R&D proposals
were received from established and new research
groups including from the leading industrial groups.
About fifty projects have been funded at different
places i.e JALMA, Agra, IIT, Kharagpur, IIT, Kanpur,
University of Delhi, South Campus, NIPER, Mohali,
as well as at Ranbaxy Labs. A “National Tuberculosis
Research Initiative” in a strategic ten- year missionlike
activity with in-built mechanism for uninterrupted
funded and strict monitoring is in place.
An Expert- cum-Working Group has been set up to
monitor the progress of the mission as also to
provide guidance on newer areas.
Work has progressed well in about 30 on-going
projects on tuberculosis. In a study on TBM
diagnosis At CIMS, Nagpur, a 30 kDa protein antigen
markers unique to CSF samples collected from
103
suspected patients was found in 89% of the TBM
patients. The studies cumulatively identified two
mycobacterial antigens, Rv3804c and Rv1886c
(Ag85A and B respectively) in the CSF of TBM
patients. Antibodies produced against the 30-kDa
protein band reacted with the whole Ag85 complex,
and the indivitual components of the Ag85 complex,
(Ag 85A and Ag 85B). Ag85 complex expression in
the CSF of TBM patients might provide prospective
insights in the area of infection by M .tuberculosis.
Immuno-modulator / Adjuvant Research
The department has been supported a double blind,
randomized, placebo-controlled multi-centric trials to
see the safety and efficacy of an immuno-modulator ,
Mycobacterium w as an adjunct to chemotherapy in
Category II of the pulmonary tuberculosis at seven
centers i.e. AIIMS, New Delhi; LRS Institute of TB &
Respiratory Diseases, New Delhi; Central JALMA
Institute for Leprosy and other Mycobacterial
Diseases, Agra; SMS Medical College, Jaipur;
N.H.L. Municipal Medical College, Ahmedabad; RNT
Medical College, Udaipur and Tuberculosis
Research Centre, Chennai . Trials are at full swing at
six centers.
The first Interim Analysis (IA) is due shortly as ¼ of
the patients have completed the treatment. IA
template for the data entry and compilation has been
firmed up. Data auditing, data cleaning and data
capture processes are going on. An independent
group under an eminent Bio-statistician has been set
up for the purpose.
About 40 patients of the randomized and 26 healthy
control subjects at AIIMS, New Delhi have been
studied for the immunophenotyping of various T cell
subset(s) and their intracellular cytokine production
profile. In the recruited patient cohort, enumeration of
various T cell subsets has shown differential
peripheral representation following vaccination.
Though patients decoding have not been done, an
over all enhancements in central and effector
memory cells on follow up visits have been observed.
Research and Development