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CTRI Number  CTRI/2020/04/024749 [Registered on: 21/04/2020] Trial Registered Prospectively
Last Modified On: 27/07/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study to Evaluate the Efficacy of Recombinant BCG VPM1002 in Reducing Infection Incidence and Disease Severity of SARS-COV-2/COVID-19 Among High-Risk Subjects  
Scientific Title of Study   A Multicenter, Phase III, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy of Recombinant BCG VPM1002 in Reducing Infection Incidence and Disease Severity of SARS-COV-2/COVID-19 Among High-Risk Subjects  
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
SII-rBCG/COVID-19/IN-01, version 5.0, dated 05.08.2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hitt Sharma 
Designation  Additional Medical Director 
Affiliation  Serum Institute Of India Pvt. Ltd. 
Address  Serum Institute Of India Pvt. Ltd. 212/2, Hadapsar, Pune India Pune

Pune
MAHARASHTRA
411028
India 
Phone  02026602451  
Fax    
Email  drhjs@seruminstitute.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Hitt Sharma 
Designation  Additional Medical Director 
Affiliation  Serum Institute Of India Pvt. Ltd. 
Address  Serum Institute Of India Pvt. Ltd. 212/2, Hadapsar, Pune India Pune

Pune
MAHARASHTRA
411028
India 
Phone  02026602451  
Fax    
Email  drhjs@seruminstitute.com  
 
Details of Contact Person
Public Query
 
Name  Dr Umesh Shaligram 
Designation  Director Research and Development 
Affiliation  Serum Institute Of India Pvt. Ltd. 
Address  Serum Institute Of India Pvt. Ltd. 212/2, Hadapsar, Pune India Pune

Pune
MAHARASHTRA
411028
India 
Phone  02026602435  
Fax    
Email  umesh.shaligram@seruminstitute.com  
 
Source of Monetary or Material Support  
Serum Institute of India Pvt. Ltd. 
 
Primary Sponsor  
Name  Serum Institute of India Pvt Ltd 
Address  212/2 Hadapsar Pune 411028 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 39  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sabah Siddiqui  All India Institute of Medical Sciences  Talibandh G.E.Road, Raipur-492099.
Raipur
CHHATTISGARH 
8518881911

dr.sabah@aiimsraipur.edu.in 
Dr Jayasree Krishnan  Apollo Speciality Hospital  Plot No 64, Vanagaram-Ambattur Rd, Ayanambakkam, Kil Ayanambakkam, Chennai-600095, Tamil Nadu
Chennai
TAMIL NADU 
9840411858

jayasree.krishnan@yahoo.co.in 
Dr Muralidhar Tambe  B. J. Medical College  Jai Prakash Narayan Road, Near Pune Railway Station, Pune - 411001, Maharashtra, India
Pune
MAHARASHTRA 
9423007898

deanbjmcpune@gmail.com 
Dr Bhaskar Deshmukh  Baramati Hospital  New Indapur Ring Road, behind K Moropant Sabhagruha, Near Central Building, Baramati-413102,Maharashtra.
Pune
MAHARASHTRA 
02112-220940

bhaskar.jedhe@gmail.com 
Dr Suninder Singh Arora  Batra Hospital and Medical Research Centre  1 Tughlakabad Institutional Area, Mehrauli Badarpur Road New Delhi-110062
South
DELHI 
9810113414

drssarora@gmail.com 
Dr Sanjay Lalwani  Bharati Vidyapeeth (Deemed to be University) Medical College & Hospital  Bharati Vidyapeeth (Deemed to be University) Medical College & Hospital, Department of Pediatrics, Pune-Satara Road, Katraj Dhankawadi,Pune-411043
Pune
MAHARASHTRA 
9822051716

sanjaylalwani2007@rediffmail.com 
Dr Nita Shanbhag  Dr D Y Patil Hospital  Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra
Mumbai
MAHARASHTRA 
9322402424

nita@eyesurgeon.in 
Dr Kirti Sabnis  Fortis Hospitals Limited  101, Mulund Goregaon Link Road, Bhandup West, Mumbai, Maharashtra - 400078 India
Mumbai
MAHARASHTRA 
9626553112

drkirtisangeet@gmail.com 
Dr Avinash Gawande  Government Medical College and Hospital  Medical College Square Road, Nagpur-440003, Maharashtra
Nagpur
MAHARASHTRA 
9822224020

dravinashgawande@gmail.com 
Dr Preeti Meshram  Grant Medical College & Sir JJ Hospital  J J Marg, Nagpada, Mumbai Central, Mumbai, Maharashtra 400008
Mumbai
MAHARASHTRA 
923198298

drpritimeshram@gmail.com 
Dr Kapil Zirpe  Grant Medical Foundation Ruby Hall Clinic  40, Sassoon Road, Pune – 411001, Maharashtra, India
Pune
MAHARASHTRA 
9822844212

kapilzirpe@gmail.com 
Dr Ashwin Porwal  Healing Hands Clinic  4th Floor, Millennium Star Extension, Adjacent to Ruby Hall Entrance Gate, Dhole Patil Road, Pune-411001, Maharashtra.
Pune
MAHARASHTRA 
9822347770

drashwinporwal@gmail.com 
Dr Raman Sardana  Indraprastha Apollo Hospitals,  Mathura Rd, Sarita Vihar, New Delhi, Delhi 110076
South
DELHI 
9811057511

ramansardana@hotmail.com 
Dr Piyush Chaudhari  Jehangir Hospital  Jehangir Hospital,Sassoon Road, Pune – 411001, Maharashtra.
Pune
MAHARASHTRA 
9341313022

drpiyushchaudhari85@gmail.com 
Dr Pradeep Dcosta  KEM Hospital Research Centre  KEM Hospital Research Centre Sardar Moodliar Road, Rasta Peth, Pune 411011
Pune
MAHARASHTRA 
02066037342

pradeepdcosta@yahoo.co.in 
Dr Himanshu Dandu  King Georges Medical University  Chowk Lucknow 226003, Uttar Pradesh
Lucknow
UTTAR PRADESH 
9839266822

dr.himanshu.reddy@gmail.com 
Dr Sujata Patil  Krishna Institute of Medical Sciences  Agashivnagar, Malkapur, Karad-415539
Satara
MAHARASHTRA 
9518723884

kimsmedcollege@gmail.com 
Dr Deepak Tayade  Mahatma Gandhi Mission hospital MGM Medical College & Hospital  N-6, CIDCO, Aurangabad – 43100
Aurangabad
MAHARASHTRA 
8788416747

drtayadepsm@gmail.com 
Dr Arun Puri  Max Super Speciality Hospital  108-A, IP Extension , Patparganj, New Delhi -110092
East
DELHI 
9811074379

arun.puri@maxhealthcare.com 
Dr R S Mishra  Max Super Speciality Hospital   Saket East Block, A unit of Devki Devi Foundation, 2, Press Enclave Road, Saket, New Delhi-110017
South
DELHI 
9810193145

rs.mishra@maxhealthcare.com 
Dr Vikas Laxman  Mysore Medical College and Research Institute  Irwin Road, Mysuru-570001, Karnataka
Mysore
KARNATAKA 
08214244081

vikilaxman@gmail.com 
Dr Shanta Dutta  National Institute of Cholera and Enteric Diseases   P- C.I.T. Scheme XM, 33, CIT Rd, Subhas Sarobar Park, Phool Bagan, Beleghata, Kolkata, West Bengal 700010
Kolkata
WEST BENGAL 
9830152971

drshantadutta@gmail.com 
Dr Aparna Kodre  Noble Hospitals Pvt. Ltd  153, Magarpatta City Road, Hadapsar, Pune - 411013, Maharashtra, India
Pune
MAHARASHTRA 
9850136436

draparnankodre@gmail.com 
Dr Ashish Bhalla  Postgraduate Institute of Medical Education and Research  Sector 12, Chandigarh-160012
Chandigarh
CHANDIGARH 
9417023973

bhalla.chd@gmail.com 
Dr Vijay Kumar Patil  Prakash Institute of Medical Sciences & Research  Urun Islampur, Islampur-Sangli Road, Islampur, Tal-Walwa, Sangli-415409. Maharashtra.
Sangli
MAHARASHTRA 
02342662300

prakashmc.research@gmail.com 
Dr Savita Verma  PT. B D Sharma Post Graduate Institute of Medical Sciences  PT. B D Sharma Post Graduate Institute of Medical Sciences, University of Health Sciences, Rohtak-124001
Rohtak
HARYANA 
9812283746

verma.savi@gmail.com 
Dr Sunita Ramanand  Rajarshee Chhatrapati Shahu MaharajGovernment Medical College and Hospital  Dasara Chowk, Town hall, Kolhapur-416002
Kolhapur
MAHARASHTRA 
9158592177

rcsmgmc.research@gmail.com 
Dr Prasita Kshirsagar  Rajiv Gandhi Medical College & Chhatrapati Shivaji Maharashtra Hospital  Kalwa West, Budhaji Nagar, Kalwa, Thane, Maharashtra 400605
Thane
MAHARASHTRA 
9867936579

prasitapk@yahoo.co.in 
Dr Govind Kulkarni  Shayadri Super Speciality Hospital  Survey No. 185A, Shastri Nagar, Near MSEB Office, Yerawada, Nagar Road, pune-41 1006, Maharashtra
Pune
MAHARASHTRA 
9822081168

drgdk2001@yahoo.com 
Dr Atul Gogia  Sir Ganga Ram Hospital  Old Rajinder Nagar, Rajinder Nagar, New Delhi, Delhi 110060
New Delhi
DELHI 
9891003450

atulgogs@gmail.com 
Dr Rupal Dosi  Sir Sayajirao General Hospital  SSG hospital,Jail Rd, Indira Avenue, Vadodara, Gujarat 390001
Vadodara
GUJARAT 
9824083734

rupal265@yahoo.com 
Dr Ramakrishnan  Sri Ramachandra Institute of Higher Education and Research  No 1, Ramachandran Nagar, Porur, Chennai -600116
Chennai
TAMIL NADU 
9940046670

tramakrishnan@hotmail.com 
Dr Poorna Prasad  Sri Venkateshwara Hospitals  No-27, 29th Main Road, Rashtra Kuvempu Nagara, BTM 2nd Stage, BTM Layout, Bengaluru-560076, Karnataka
Bangalore
KARNATAKA 
08025630006

spoornaprasad123@gmail.com 
Dr Nellaippa Ganesan  SRM College Chennai  SRM Nagar, Kattankulathur, Chengalpattu, Tamil Nadu - 603203
Kancheepuram
TAMIL NADU 
9361860009

nells220152@gmail.com 
Dr Abhay Vispute  SRV Hospital  Dr Mandakini Parihar Marg opposite Lokmanya Tilak Terminus, Tilak Nagar, Chembur, Mumbai, Maharashtra 400089
Mumbai
MAHARASHTRA 
02250120000

surgician@gmail.com 
Dr Urvi Shukla  Symbiosis University Hospital and Research Centre  Symbiosis International University, Gram Lavale, Tal. Mulshi, Pune - 412115
Pune
MAHARASHTRA 
9922994977

shuklaurvi@yahoo.com 
Dr Renuka Munshi  TNMC & NAIR HSOPITAL  55,Dr Anandrao Nair Marg, Mumbai Central, Mumbai, Maharashtra, 400008
Mumbai
MAHARASHTRA 
9811131719

raj.rkmjs@gmail.com 
Dr Abhishek Karmalkar  Vedant Multispeciality Hospital  Sambhaji Nagar, Chinchwad, Pimpri-Chinchwad-411019, Maharashtra.
Pune
MAHARASHTRA 
9850337271

dr.karmalkar@gmail.com 
Dr Pravin Soni  Yashwantrao Chavan Memorial Hospital  YCM Hospital Road, Sant Tukaram Nagar, Pimpri Colony, Pune - 411018, Maharashtra, India
Pune
MAHARASHTRA 
9822057511

drpravinsoni18@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 39  
Name of Committee  Approval Status 
Aditya Jyot Eye Hospital Ethics Committee, Mumbai  Approved 
Ethics Committee For Research On Human Subjects, MGM Aurangabad  Approved 
Ethics Committee of Pulse Multispeciality Hospital, Pune  Approved 
Ethics Committee, Jehangir Clinical Development Centre Pvt Ltd  Approved 
Ethics Committee, PGI Chandigarh  Approved 
Ethics Committee, Rao Nursing Home, Pune  Approved 
IEC, PCMCs, PGI, Yashwantrao Chavan Memorial Hospital  Approved 
Independent Ethics Committee of Symbiosis International University  Approved 
Institutional Clinical Ethics Committee , RGMC & CSMH, Thane  Approved 
Institutional Ethics Committe King Georges Medical University  Approved 
Institutional Ethics Committe, RCSMGMCIEC II, Kolhapur  Approved 
Institutional Ethics Committee National Institute of Cholera and Enteric Diseases   Approved 
Institutional Ethics Committee - Clinical Studies, Apollo Hospital, Chennai  Approved 
Institutional Ethics Committee Bharati Vidyapeeth Deemed University  Approved 
Institutional Ethics Committee for Human Research, Baroda Medical College, Vadodara  Approved 
Institutional Ethics Committee Max Super Speciality Hospital, Patparganj  Approved 
Institutional Ethics Committee Max Super Speciality Hospital, Saket  Approved 
Institutional Ethics Committee Mysore Medical College and Research Institute and Associated Hospitals  Approved 
Institutional Ethics Committee TNMC Nair Hospital  Approved 
Institutional Ethics Committee, AIIMS, Raipur  Approved 
Institutional Ethics Committee, B.J.G. Medical College and Sassoon General Hospitals, Pune  Approved 
Institutional Ethics Committee, D Y Patil Medical College, Navi Mumbai  Approved 
Institutional Ethics Committee, Fortis Hospital, Mumbai  Approved 
Institutional Ethics Committee, Government Medical College, Nagpur   Approved 
Institutional Ethics Committee, Grant Medical College, Mumbai  Approved 
Institutional Ethics Committee, Indraprastha Apollo Hospitals, New Delhi  Approved 
Institutional Ethics Committee, Krishna Institute of Medical Sciences, Karad  Approved 
Institutional Ethics Committee, Poona Medical Research Foundation, Pune  Approved 
Institutional Ethics Committee, PT. B D Sharma Post Graduate Institute of Medical Sciences, Rohtak  Approved 
Institutional Ethics Committee, SRM College Chennai  Approved 
Institutional Ethics Committee, SRMC Chennai  Approved 
KEM Hospital Research Centre Ethics Committee, Pune  Approved 
Nikop Institutional Ethics Committe  Approved 
Noble Hospital Institutional Ethics Committee  Approved 
Prakash Medical College, Institutional Ethics Committee   Approved 
Sahyadri Hospitals Ltd Ethics Committee  Approved 
Scientific Research and Ethics Review Committee, Batra Hospital and Medical Research Center, New Delhi  Approved 
Sir Ganga Ram Hospital Ethics Commitee  Approved 
Sri Venkateshwara Hospitals Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, (2) ICD-10 Condition: Z23||Encounter for immunization,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo, 0.9% sodium chloride  Dose : 0.1 ml, single dose to be administered as an intradermal injection  
Intervention  recombinant BCG vaccine, VPM1002  Dose : 0.1 ml, single dose of the reconstituted vaccine to be administered as an intradermal injection  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Male or Female subjects ≥ 18 years of age at high-risk of SARS-CoV-2/COVID-19 infection
2. Test negative for SARS-CoV-2 infection (RT-PCR test) at screening
3. Capable of giving informed consent 
 
ExclusionCriteria 
Details  1. Previous history of Tuberculosis or known active Mycobacterium tuberculosis infection
2. Received BCG vaccine within one year prior to screening
3. Fever (greater than or equal to 38 ºC/100.4°F) or any other respiratory symptoms/illnesses within the past 14 days
4. Pregnant or lactating women
5. Women of child-bearing potential not agreeing to use adequate contraception
6. Current active viral or bacterial infection
7. Expected vaccination during the study period, independently of the type of vaccination
8. Severely immunocompromised subjects.
9. Active solid or non-solid malignancy or lymphoma within the prior two years
10. Individuals known to be hypersensitive to any component of the vaccine
11. Eczema or other significant skin lesion or infection at the site/s of injection.
12. Any other medical condition which in the opinion of the investigator may affect the subject’s safety or study participation and conduct
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Number of subjects with laboratory confirmed COVID-19 infection among HCWs
2.Number of subjects with laboratory confirmed COVID-19 infection among other high-risk subjects
3.Number of laboratory confirmed COVID-19 infection with severe, critical or life-threatening disease as assessed by Investigator among HCWs
4.Number of laboratory confirmed COVID-19 infection with severe, critical or life-threatening disease as assessed by Investigator among other high-risk subjects 
up to 6 months (180 days) following vaccine administration 
 
Secondary Outcome  
Outcome  TimePoints 
1.Duration of COVID-19 symptoms in HCWs
2.Duration of COVID-19 symptoms in other high-risk subjects
3.Severe Disease Outcomes in HCWs
4.Severe Disease Outcomes in other high-risk subjects
5.Severe Disease Outcomes among in elderly subjects (greater than or equal to 60 years)
6.Severe Disease Outcomes among subjects with Co-morbidities
7.Incidence of Adverse Events and Serious Adverse Events  
up to 6 months (180 days) following vaccine administration 
 
Target Sample Size   Total Sample Size="5946"
Sample Size from India="5946" 
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 3 
Date of First Enrollment (India)   21/04/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This is a placebo controlled, multicentric, randomized, double blind, adaptive study to evaluate the reduction in infection incidence and severity of SARS-CoV-2/ COVID-19 infection among high-risk subjects by enhanced trained immune response through VPM1002 vaccine. Subjects who provide informed consent will be assessed for eligibility criteria. The subjects who fulfill all the eligibility criteria will be randomized in a 2:1 ratio to receive a single dose (0.1 ml) of either VPM1002 or placebo, administered as an intradermal injection. The duration of follow-up will be based on the results of interim analysis however the maximum follow-up period will be up to 180 days. 

 
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