| CTRI Number |
CTRI/2017/03/008266 [Registered on: 30/03/2017] Trial Registered Prospectively |
| Last Modified On: |
26/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
A study to check the efficacy and safety of recombinant BCG vaccine in prevention of TB recurrence. |
Scientific Title of Study
Modification(s)
|
A Multicenter Phase II/III Double – Blind, Randomized, Placebo Controlled study To evaluate the Efficacy and the safety of VPM1002 in the prevention of tuberculosis (TB) recurrence In pulmonary TB patients after successful TB treatment. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| VPM1002-IN-3.01TBR VERSION:3.0DATED 23 MARCH 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Prasad Kulkarni |
| Designation |
Executive Director |
| Affiliation |
Serum Institute of India Pvt. Ltd. |
| Address |
Serum Institute of India Pvt. Ltd.
212/2, Off Soli Poonawala Road, Hadapsar, Pune 411 028
Pune, MAHARASHTRA, India
Pune
MAHARASHTRA
411028
India |
| Phone |
02026602384 |
| Fax |
|
| Email |
drpsk@seruminstitute.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sajjad Desai |
| Designation |
Deputy Medical Director |
| Affiliation |
Serum Institute of India Pvt. Ltd. |
| Address |
Serum Institute of India Pvt. Ltd.
212/2, Off Soli Poonawala Road, Hadapsar, Pune 411 028
Pune, MAHARASHTRA, India
Pune
MAHARASHTRA
411028
India |
| Phone |
02026602781 |
| Fax |
|
| Email |
sajjad.desai@seruminstitute.com |
|
|
Source of Monetary or Material Support
|
| Serum Institute Of India Pvt. Ltd.
212 / 2, Off Soli Poonawalla Road, Hadapsar, Pune – 411028, India |
|
|
Primary Sponsor
|
| Name |
SERUM INSTITUTE OF INDIA PVT LTD |
| Address |
SERUM INSTITUTE OF INDIA PVT. LTD.
212 / 2, Off Soli Poonawalla Road, Hadapsar, Pune – 411028, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
Modification(s)
|
India
Bangladesh |
Sites of Study
Modification(s)
|
| No of Sites = 15 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjay Gaikwad |
B.J. Govt. Medical College and Sassoon General Hospitals Pune |
Pulmonary Medicine, B.J. Govt. Medical College and Sassoon General Hospitals & College of Nursing, Jai Prakash Narayan Road, Near Pune Railway Station, Pune, Maharashtra 411001
Pune
MAHARASHTRA |
020-61268000
sangaiabdc@gmail.com |
| Dr Clarence Samuel |
Christian Medical College and Hospital, Ludhiana |
Christian Medical College and Hospital, Ludhiana,
Punjab-141008
Ludhiana
PUNJAB |
9988099867
clarencejs@yahoo.com |
| Dr D J Christopher |
Christian Medical College and Hospital, Vellore |
Christian Medical College and Hospital, Vellore,
Tamil Nadu-632004
Chennai
TAMIL NADU |
9443306573
djchris@cmcvellore.ac.in |
| Dr Abhishek Raut |
Dr. Sushila Nayar School of Public Health, Sewagram, Maharashtra |
Dr. Sushila Nayar
School of Public Health
Mahatma Gandhi
Institute of Medical
Sciences, Department
of Community
Medicines, Sewagram,
Maharashtra.
Pune
MAHARASHTRA
Wardha
MAHARASHTRA |
07152284341
07152284333
abhishekraut@mgims.ac.in |
| Dr Sushant Meshram |
Govt. Medical College and Hospital, Nagpur |
Dept. of Respiratory Medicine,
Critical Care and Sleep Medicine
Super Specialty Hospital,
Govt. Medical College and Hospital,
Nagpur- 440003, Maharashtra, India
Nagpur
MAHARASHTRA |
00919860990379
drsushant.in@gmail.com |
| Dr K Zaman |
International Center for Diarrheal Disease Research, Bangladesh |
International Center for Diarrheal Disease Research Bangladesh, Matlab, Chandpur Bangladesh
|
88029827001
kzaman@icddrb.org |
| Dr Sonali Sarkar |
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry |
Jawaharlal Institute of Postgraduate Medical
Education and Research, Puducherry-605006
Pondicherry
PONDICHERRY |
9442174663
04132272066
sarkarsonaligh@gmail.com |
| Dr Veena G Kamath |
Kasturba Medical College, Manipal |
Department of
Community Medicine,
Kasturba Medical
College, Manipal,
Karnataka, PIN-576
104
Udupi
KARNATAKA
Udupi
KARNATAKA |
0820-2922324
veenak@manipal.edu |
| Dr Pradeep DCosta |
KEM Hospital Research Centre Pune |
KEM Hospital Research Centre Pune,
KEM Hospital Pune Ankit Shirdi Saibaba Rural Hospital, A/P- Vadu Budruk, Taluka - Shirur
District- Pune. 412216, Maharashtra, India.
Pune
MAHARASHTRA |
00919822632812
pradeepdcosta@yahoo.co.in |
| Dr Valluri Satya Prasad |
King George Hospital, Visakhapatnam |
Department of General Medicine , GHCCD, King George Hospital,
Andhra Medical College, Maharanipeta, Visakhapatnam - 530002, Andhra Pradesh, India.
Visakhapatnam
ANDHRA PRADESH |
9393104578
drvsatyaprasadresearch@gmail.com |
| Dr Sindhu Joshi |
Mahavir Hospital & Research Centre, Hyderabad |
Department of Internal Medicine, Mahavir Hospital & Research Centre, Hyderabad-
500004
Hyderabad
TELANGANA |
040-23316057
dr_sindhu@yahoo.com |
| Dr Vijay Viswanathan |
MV Hopsital for Diabetes Pvt Ltd, Chennai |
MV Hopsital for Diabetes Pvt Ltd, Royapuram,
Chennai-600013
Chennai
TAMIL NADU |
044-25954913
044-25954919
drvijay@mvdiabetes.com |
| Dr Madhu Gupta |
Post Graduate Institute of Medical Education and Research, Chandigarh |
Post Graduate Institute of Medical Education and
Research, Chandigarh - 160012
Chandigarh
CHANDIGARH |
9914208226
01722744401
madhugupta21@gmail.com |
| Dr Pramod Thakral |
SP Medical College and A G Hospitals, Bikaner |
Department of TB and Chest,
SP Medical College and A G Hospitals,
Bikaner, Rajasthan 334003, India
Bikaner
RAJASTHAN |
00911512525451
drparmodthakralspmc@gmail.com |
| Dr T Dhanasekar |
Sri Ramachandra Hospital, Chennai |
Pulmonary Medicine,
Sri Ramachandra Hospital, Porur, Chennai, Tamil Nadu 600116
Chennai
TAMIL NADU |
9443037627
drdhansekar@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 15 |
| Name of Committee |
Approval Status |
| Ethics Committee S P Medical College Bikaner |
Approved |
| Ethics Committee, B J Medical College and Sasoon General Hospital Pune |
Approved |
| Institute Ethics Committee (Human Studies) Jawaharlal Institute of Postgraduate Medical Education and Research |
Approved |
| Institutional Ethics Committee Christian Medical College, Ludhiana |
Approved |
| Institutional Ethics Committee for Research on human Subjects, Sewagram |
Approved |
| Institutional Ethics Committee King George Hospital Visakhapatanam |
Approved |
| Institutional Ethics Committee L R S Institute of Tuberculosis and Respiratory Diseases |
Submittted/Under Review |
| Institutional Ethics Committee of Bhagwan Mahavir Medical Research Center for Bio-Medical Research Hydrabad |
Approved |
| Institutional Ethics Committee PGIMER |
Approved |
| Institutional Ethics Committee, GMC, Nagpur |
Approved |
| Institutional Review Board, Christian Medical College, Vellore |
Approved |
| KEM Hospital Research Center Ethics Committee |
Approved |
| Manipal University Ethics Committee, Manipal |
Approved |
| National Institute for Research in Tuberculosis Institutional Ethics Committee |
Approved |
| Prof M Vishwanathan Diabetes Research Center Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Pulmonary TB Patients after successfull TB treatment and were declared cured, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Freeze dried powder containing dextran, glucose and water for injection as solvent |
| Intervention |
VPM1002 |
The active ingredient of the recombinant BCG vaccine, VPM1002 is Mycobacterium bovis rBCGΔureC::Hly+, freeze-dried and standardized to number of viable mycobacteria (colony forming units; CFU) per application |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
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
Modification(s)
|
| Outcome |
TimePoints |
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 |
From two months to twelve months after vaccination |
|
|
Target Sample Size
|
Total Sample Size="2000"
Sample Size from India="2000"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
01/07/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/07/2017 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
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. |