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CTRI Number  CTRI/2019/01/017026 [Registered on: 10/01/2019] Trial Registered Prospectively
Last Modified On: 25/03/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine
Preventive 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To study effect of two vaccines in preventing spread of tuberculosis in persons living with new tuberculosis patients. 
Scientific Title of Study   A Phase III, Randomized, Double-blind, three arm Placebo controlled Trial to Evaluate the Efficacy and Safety of two vaccines VPM1002 and Immuvac in Preventing Tuberculosis (TB) in Healthy Household Contacts of Newly Diagnosed Sputum Positive Pulmonary TB Patients. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ICMR/ITRC/VAC/001/2018, Version 1.5, dated 3rd october 2018  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Manjula Singh 
Designation  Scientist F 
Affiliation  ICMR 
Address  Indian Council of Medical Research V Ramalingaswami Bhawan P O Box No 4911 Ansari Nagar New Delhi - 110029 India

New Delhi
DELHI
110096
India 
Phone  9868245793  
Fax  01126588296  
Email  drmanjulasb@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manjula Singh 
Designation  Scientist E 
Affiliation  ICMR 
Address  Indian Council of Medical Research V. Ramalingaswami Bhawan P O Box No 4911 Ansari Nagar New Delhi - 110029 India

New Delhi
DELHI
110029
India 
Phone  9868245793  
Fax  01126588896  
Email  manjulas@icmr.org.in  
 
Details of Contact Person
Public Query  
Name  Dr Manjula Singh 
Designation  Scientist E 
Affiliation  ICMR 
Address  Indian Council of Medical Research V. Ramalingaswami Bhawan P O Box No 4911 Ansari Nagar New Delhi - 110029 India

New Delhi
DELHI
110029
India 
Phone  9868245793  
Fax  01126588896  
Email  manjulas@icmr.org.in  
 
Source of Monetary or Material Support  
Indian Council of Medical Research 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  Indian Council of Medical Research Ansari Nagar New Delhi 110029 India 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Randeep Guleria  All India Institute of Medical Science  Ansari Nagar, New Delhi -110029
New Delhi
DELHI 		 9810184738

director.aiims@gmail.com 
Dr Sindu Joshi  Bhagwan Mahavir Medical Research Centre  Plot No. 10-1- 1, AC Guards, Masab Tank, Hyderabad, Telangana 500004
Hyderabad
ANDHRA PRADESH 		 9391099991

dr_sindhu@yahoo.com 
Dr Samiran Panda  National AIDS Research Institute  Plot No 73, G-block, M I D C, Bhosari, Pune, Maharashtra 411026
Pune
MAHARASHTRA 		 9830908475

director@nariindia.org 
Dr Srikanth Tripathy   National Institute for Research in Tuberculosis and Madurai Unit  No. 8/1-2, Mayor Sathyamoorthy Street, Korukkupet, Chetpet, Chennai, Tamil Nadu 600031
Chennai
TAMIL NADU 		 9506779797

directornirt@nirt.res.in 
Dr Rohit Sarin  National Institute of Tuberculosis and Respiratory Diseases  Sri Aurobindo Marg, New Delhi -110030
New Delhi
DELHI 		 9999971557

r.sarin@nitrd.nic.in 
Dr N Somashekar  National Tuberculosis Institute  8, Avalon, Bellary Rd, Near Cauvery Theatre, Guttahalli, Bengaluru, Karnataka 560003
Bangalore
KARNATAKA 		 08023441192

nti@ntiindia.org.in 
Dr Sanghamitra Pati  Regional Medical Research Centre  Nandankanan Rd, SamantaVihar, Gajapati Nagar, Bhubaneswar, Odisha 751017
Gajapati
ORISSA 		 9437093306

drsanghamitra12@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
AIIMS Bhubaneswar IEC  Approved 
AIIMS Delhi EC  Submittted/Under Review 
BMMRC Hyderabad EC  Approved 
Ethics Commitee RMRC Bhubaneswar  Approved 
Ethics Committee NIRT Chennai  Approved 
Madurai Medical College& Govt Rajaji Hosp, IEC  Approved 
Medicity Ethics Committee  Approved 
NARI Pune EC  Approved 
NITRD Delhi EC  Approved 
NTI Bangalore EC  Approved 
SCB Medical College&Hosp_IEC  Approved 
StJohns Medical College and Hospital IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Household Contacts of Newly Diagnosed Sputum Positive Pulmonary Tuberculosis Patients. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  IMMUVAC  Immuvac is a heat killed suspension of Mycobacterium w, a non-pathogenic, cultivable atypical mycobacterium. Frequency and dose: 1st dose: 0.2ml intradermal in two divided doses 2nd dose: 0.1ml intradermal after 4 weeks 
Comparator Agent  Placebo  Aqueous solution containing thiomerosal (0.1 mg/ml), sodium chloride (pyrogen free – 9 mg/ml) and water for injection (q.s. to 1.0 ml) . This investigational product is supplied by Cadila Pharmaceuticals, Ahmedabad, India.  
Intervention  VPM1002   The active ingredient of the recombinant BCG vaccine, VPM1002 is Mycobacterium bovis rBCGΔureC: Hly+, freeze-dried/lyophilized and standardized to number of viable mycobacteria (colony forming units; CFU) per application. Frequency: 0.1ml intradermal single dose 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  i. Healthy household contacts age ≥ 6 years at the time of enrollment.
ii. No evidence of active TB disease during screening – Normal chest radiograph with no abnormalities and no bacteriological positivity by smear testing for M.tb
iii. Female participants who are currently using reliable methods of contraception (barrier methods and intrauterine contraceptive device), with a negative urine pregnancy test during screening and agree to informed compliance of contraceptive method until at least 4 months post-vaccination.
iv. The participant must be able and willing to comply with the study protocol, available and willing to complete all the study assessments and must have signed an Informed Consent Form.
v. Participant agrees to stay in contact with the study site for the duration of the study, and provide updated and an alternate contact information.
vi. Has general good health, as confirmed through medical history and medical evaluation (which includes physical examination and laboratory tests).
 
 
ExclusionCriteria 
Details  i. Any chronic febrile illness with oral temperature > 100°F on the day of randomization.
ii. Prior or present anti-TB treatment
iii. Any laboratory abnormalities (haematological and biochemical), at the time of screening, which is of clinical significance as determined by the Investigator.
iv. Pregnant and / or lactating female participants.
v. Presence of any illness requiring short hospital referral (temporary exclusion).
vi. Reactive serology for HIV.
vii. Any confirmed or suspected immunodeficient condition based on medical history and physical examination and a family history of congenital or hereditary immunodeficiency.
viii. History of chronic renal failure/dialysis, silicosis, gastrectomy, jejunoileal bypass, solid organ transplantation such as renal or cardiac transplants, carcinoma of the head and neck, and disorders of the liver, kidney, lung, heart, or nervous system, or other metabolic inflammatory conditions, psychiatric, occupational problems that make it unlikely the volunteer will comply with the protocol as determined by the local investigator.
ix. History of previous administration of experimental MTB vaccines.
x. History of administration of any immunoglobulins, any immunotherapy (antineoplastic chemotherapy, radiation therapy, immunosuppressants to induce tolerance to transplants, and corticosteroids use) and/or any blood products within the 3 months preceding study vaccination, or planned future administrations during the study period. Participants on inhaled/topical steroids may be permitted to participate in the study.
xi. Participation in any clinical trial within 3 months prior to and/or planned concurrent participation in another interventional clinical trial at any point throughout the entire timeframe for this study.
xii. History of allergic reactions or anaphylaxis to any vaccine or component of the vaccine.
xiii. Presence of any severe systemic/autoimmune disorders as determined by medical history and / or physical examination/ or lab investigations at the time of screening, which in the judgment of the Investigator would compromise the participant’s health or is likely to result in nonconformance to the protocol or a participant’s ability to give written informed consent/assent.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the percentage of confirmed TB cases (PTB and EPTB) as per RNTCP guidelines in the vaccinated and placebo groups from 2 months after first dose of vaccine till 38 months follow-up period (VPM1002, Immuvac and Placebo).  1 year, 2 year and 3 year post-vaccination. 
 
Secondary Outcome  
Outcome  TimePoints 
Number of participants developing LTBI, adverse events, protection from all types of TB and Immune Response to Vaccines.  LTBI-6 months,
Adverse events-after vaccination till end of study period.
Immune Response-day 0, 2 months, 6 months, and at the time of deveopment of TB. 
 
Target Sample Size   Total Sample Size="12000"
Sample Size from India="12000" 
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)   25/01/2019 
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="3"
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   None. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This is a a Phase III, Randomized, Double-blind, Placebo controlled Trial to Evaluate the Efficacy and Safety of VPM1002 and Immuvac Vaccines in Preventing Tuberculosis (TB) in Healthy Household Contacts of Newly Diagnosed Sputum Positive Pulmonary TB Patients, sponsored by ITRC, ICMR. Approximately12000 healthy household contacts of newly diagnosed PTB patients at six states (sites and sub-sites) in India. The primary objective of the study is to evaluate the efficacy of VPM1002 and Immuvac by comparing the reduction in incidence of TB over 3-year period among Indian healthy household contacts of newly diagnosed sputum positive PTB patients vaccinated with VPM1002 and Immuvac in comparison to placebo. The secondary objectives include to evaluate the efficacy of VPM1002 and Immuvac in prevention of LTBI in healthy household contacts of newly diagnosed sputum positive PTB patients in comparison to placebo [at 3 sites]; to evaluate the safety of VPM1002 and Immuvac in Indian healthy household contacts; and to evaluate the Immunogenicity of VPM1002 and Immuvac in healthy household contacts as compared to placebo against tuberculosis [at 3 sites]. Interim analysis will be done at the time when 80 incident TB cases are observed in the trial or 50% of recruitment is completed, whichever is earlier. Final analysis will be done at the time when 160 incident TB cases are observed in the trial or end of follow up period whichever is earlier.

 


 
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