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1 Clinical Trial Details (PDF Generation Date :- Mon, 01 Oct :13:09 GMT) CTRI Number Last Modified On 13/06/2018 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2017/03/ [Registered on: 30/03/2017] - Trial Registered Prospectively Interventional Vaccine Randomized, Parallel Group, Placebo Controlled Trial A study to check the efficacy and safety of recombinant BCG vaccine in prevention of TB recurrence. A Multicenter Phase II/III Double-Blind, Randomized, Placebo Controlled Study To Evaluate The Efficacy And Safety Of VPM1002 In The Prevention Of Tuberculosis (TB) Recurrence In Pulmonary TB Patients After Successful TB Treatment In Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) VPM1002-IN-3.01TBR Version 2.0 dated 10 Dec 2016 Designation Affiliation Protocol Number Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Designation Affiliation Details Contact Person (Scientific Query) Dr Prasad Kulkarni Medical Director Phone Fax Designation Affiliation Serum Institute of Pvt. Ltd. Serum Institute of Pvt. Ltd. 212/2, Off Soli Poonawala Road, Hadapsar, ,, drpsk@seruminstitute.com Details Contact Person (Public Query) Dr Sajjad Desai Deputy Medical Director Serum Institute of Pvt. Ltd. Serum Institute of Pvt. Ltd. 212/2, Off Soli Poonawala Road, Hadapsar, ,, page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax Source of Monetary or Material Support > Serum Institute Of Pvt. Ltd. 212 / 2, Off Soli Poonawalla Road, Hadapsar, , Type of Sponsor NIL List of Countries of Principal Investigator Dr Sanjay Gaikwad Dr Clarence Samuel Dr D J Christopher Dr B S Garg Dr Dinesh Kumar Primary Sponsor Details SERUM INSTITUTE OF INDIA PVT LTD SERUM INSTITUTE OF INDIA PVT. LTD. 212 / 2, Off Soli Poonawalla Road, Hadapsar, , Pharmaceutical industry-n NIL of Site Site Phone/Fax/ B.J. Govt. Medical College and Sassoon General Hospitals Ludhiana Vellore Dr. Sushila Nayar School of Public Health, Sewagram, Maharashtra Government Medical College, Jammu city, Jammu Pulmonary Medicine, B.J. Govt. Medical College and Sassoon sangaiabdc@gmail.com General Hospitals & College of Nursing, Jai Prakash Narayan Road, Near Railway Station,, Maharashtra Ludhiana, Punjab Ludhiana PUNJAB Vellore, Tamil Nadu TAMIL NADU Dr. Sushila Nayar School of Public Health Mahatma Gandhi Institute of Medical Sciences, Department of Community Medicines, Sewagram, Maharashtra. Wardha Government Medical College, Jammu city, Jammu and Kashmir clarencejs@yahoo.com djchris@cmcvellore.ac.i n gargbs@gmail.com dineshgmcjamcmcl@g mail.com page 2 / 6

3 Dr S C Parija Dr Veena G Kamath Dr Pradeep DCosta Dr Mohd Soheb Sadath Ansari Dr Vijay Viswanathan Dr Srikanth Tripathy Dr Rohit Sarin Dr Avi Kumar Bansal Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry Kasturba Medical College, Manipal KEM Hospital Research Centre Mahavir Hospital & Research Centre, Hyderabad MV Hopsital for Diabetes Pvt Ltd, National Institute for Research in Tuberculosis, National Institute of Tuberculosis and Respiratory Diseases, New Delhi National JALMA Institute for Leprosy & Other Mycobacterial Diseases Jammu JAMMU & KASHMIR Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry Pondicherry PONDICHERRY Department of Community Medicine, Kasturba Medical College, Manipal, Karnataka, PIN Udupi KARNATAKA Udupi KARNATAKA KEM Hospital Research Centre, KEM Hospital Ankit Shirdi Saibaba Rural Hospital, A/P- Vadu Budruk, Taluka - Shirur District , Maharashtra,. Mahavir Hospital & Research Centre, Hyderabad Hyderabad ANDHRA PRADESH MV Hopsital for Diabetes Pvt Ltd, Royapuram, TAMIL NADU National Institute For Research In Tuberculosis.1, Sathiyamoorthy Road Chetput TAMIL NADU National Institute of Tuberculosis and Respiratory Diseases, New Delhi New Delhi DELHI P. B.. 101, Taj East Gate Road, Dr. M. Miyazaki Marg, Tajganj, Agra, Uttar Pradesh Agra subhashparija@yahoo. co.in veenak@manipal.edu pradeepdcosta@yahoo. co.in mohdsoheb@yahoo.co. in drvijay@mvdiabetes.co m srikanthtripathy@gmail. com drsarin@yahoo.com bansalavikumar@gmail. com page 3 / 6

4 Details of Ethics Committee Dr Madhu Gupta Post Graduate Institute of Medical Education and Research, Chandigarh UTTAR PRADESH Post Graduate Institute of Medical Education and Research, Chandigarh Chandigarh CHANDIGARH madhugupta21@gmail. com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Ethics Committee, B J Medical College and Sasoon General Hospital Ethics Committee, Government Medical College, Jammu Human Ethics Committee, National JALMA Institute for Leprosy & other Mycobacterial Disease Agra Institute Ethics Committee (Human Studies) Jawaharlal Institute of Postgraduate Medical Education and Research Committee Christian Medical College, Ludhiana Committee for Research on human Subjects, Sewagram Approved 29/03/2017 Submittted/Under Review Submittted/Under Review Submittted/Under Review Submittted/Under Committee L R S Review Institute of Tuberculosis and Respiratory Diseases Committee of Bhagwan Mahavir Medical Research Center for Bio-Medical Research Hydrabad Committee PGIMER Institutional Review Board, Christian Medical College, Vellore KEM Hospital Research Center Ethics Committee Date Specified Date Specified Date Specified Approved 26/10/2017 Approved 18/08/2017 Date Specified Approved 24/07/2017 Approved 01/02/2018 Approved 10/04/2017 Approved 24/06/2017 page 4 / 6

5 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Method of Generating Random Sequence Manipal University Ethics Committee, Manipal National Institute for Research in Tuberculosis Committee Prof M Vishwanathan Diabetes Research Center Institutional Ethics Committee Status Approved 20/03/2017 Approved 28/02/2018 Approved 14/03/2017 Date Approved/Obtained 20/03/2017 Health Type Patients Condition Pulmonary TB Patients after successfull TB treatment and were declared cured Type Details Intervention VPM1002 The active ingredient of the recombinant BCG vaccine, VPM1002 is Mycobacterium bovis rbcg?urec::hly+, freeze-dried and standardized to number of viable mycobacteria (colony forming units; CFU) per application Comparator Agent Placebo Freeze dried powder containing dextran, glucose and water for injection as solvent Age From Age To Gender Details Details Stratified randomization Year(s) Year(s) Both Inclusion Criteria 1. Males or females aged more than or equal to 18 and less than or equal to 65 years 2. Bacteriologically confirmed Category I pulmonary TB patients (including controlled diabetics with HbA1c level less than or equal to 7% and non-diabetics) who successfully completed ATT as per national guidelines. 3. Must have a sputum sample showing bacteriologic confirmation of cure - defined as smear negative. 4.Female participants who are currently using reliable methods of birth control, have a negative pregnancy test during screening and have no intention to become pregnant for at least 3 months post-vaccination Exclusion Criteria 1. Reactive serology for HIV 2. History of extrapulmonary TB 3. Current or known history or family history of multidrug-resistant or extensively-drug-resistant TB 4. Known or suspected impairment of immunological function 5. Pregnant and / or lactating female participants. page 5 / 6

6 Powered by TCPDF ( PDF of Trial Method of Concealment Blinding/Masking Centralized Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded Primary Outcome Outcome Timepoints Bacteriologically confirmed TB recurrence cases From two months to 12 months after vaccination Secondary Outcome Outcome Timepoints Target Sample Size Efficacy: Overall TB recurrence (Bacteriologically confirmed and clinically diagnosed cases) Safety: o Solicited local and regional reactogenicity events within 2 months following study vaccination o Unsolicited adverse events o SAEs throughout the study period Total Sample Size=2000 Sample Size from =2000 Phase of Trial Phase 2/ Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details - 01/07/2017 Date Specified Years=1 Months=2 Days=0 t Applicable Open to Recruitment From two months to twelve months after vaccination Brief Summary This is Phase II/III study designed as a multicenter, double-blinded, randomized, placebo-controlled trial with two groups of adults successfully cured of TB receiving either VPM1002 or placebo. Single dose of VPM1002 / placebo will be administered to former TB patients who have successfully completed Category I ATT, were declared cured. The vaccine will be administered intradermally. page 6 / 6