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CTRI Number  CTRI/2023/01/048867 [Registered on: 10/01/2023] Trial Registered Prospectively
Last Modified On: 10/09/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Epidemiologic study to assess the IGRA positivity in populations with a high TB burden 
Scientific Title of Study   A multi-country, epidemiologic study to assess the interferon gamma release assay (IGRA) positivity, and to build capacity to conduct a tuberculosis (TB) vaccine efficacy study, in populations with a high TB disease burden 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Gates MRI TBV02-E01, Ver 2.0 dated 19Aug2021  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  
Name  Rashmi Chitgupi 
Designation  Country Head - Clinical Management 
Affiliation  PPD Pharmaceutical Development India Private Limited 
Address  PPD Pharmaceutical Development India Private Limited, 101, A Wing, Fulcrum, Hiranandani Business Park, Sahar Road, Andheri East, Mumbai Mumbai (Suburban) MAHARASHTRA 400099 India

Mumbai
MAHARASHTRA
400099
India 
Phone  912266022900  
Fax    
Email  rashmi.chitgupi@ppd.com  
 
Details of Contact Person
Public Query  
Name  Rashmi Chitgupi 
Designation  Country Head - Clinical Management 
Affiliation  PPD Pharmaceutical Development India Private Limited 
Address  PPD Pharmaceutical Development India Private Limited, 101, A Wing, Fulcrum, Hiranandani Business Park, Sahar Road, Andheri East, Mumbai Mumbai (Suburban) MAHARASHTRA 400099 India

Mumbai
MAHARASHTRA
400099
India 
Phone  912266022900  
Fax    
Email  rashmi.chitgupi@ppd.com  
 
Source of Monetary or Material Support  
Bill & Melinda Gates Medical Research Institute (Gates MRI) 
 
Primary Sponsor  
Name  Bill & Melinda Gates Medical Research Institute (Gates MRI) 
Address  One Kendall Square Building 600, Suite 6-301 Cambridge, MA 02139 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     Bangladesh
Brazil
Democratic Republic of the Congo
Kenya
Mozambique
Peru
Philippines
South Africa
Uganda
Viet Nam
Zambia
Gambia
India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepali Gaikwad  PCMC Post Graduate Institute, Yashwantrao Chavan Memorial Hospital  2nd Floor, Clinical Research Department, Sant Tukaram Nagar, Near D.Y. Patil Medical College, Vallabhnagar, Pimpri, Pune - 411018
Pune
MAHARASHTRA 		 9767104009

drg1818@rediffmail.com 
Dr Madhu Gupta   Post Graduate Institute of Medical Education and Research(PGIMER)  Department of Community Medicine and School of Public Health, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh, 160012, India
Chandigarh
CHANDIGARH 		 7009768629

madhugupta21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
PCMC Post Graduate Institute, YashwantRao Chavan Memorial Hospital  Approved 
Post Graduate Institute of Medical Education and Research, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Notified 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  N/A 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  34.00 Year(s)
Gender  Both 
Details  1. Capable of giving signed informed consent and informed assent (as appropriate), which includes compliance with the requirements listed in the informed consent form (ICF) and informed assent form (IAF)
2. Between 15 and 34 years of age (inclusive)
3. Participants who agree to stay in contact with the study site for the duration of the study,
provide updated contact information as necessary and have no current plans to relocate from the study area for the duration of the study. 
 
ExclusionCriteria 
Details  1. History of active TB within the last 24 months (i.e., 24 months from end of treatment to day
of screening, based on history [no documentation required])
2. History of previous administration of an experimental Mtb vaccine
3. Unstable/uncontrolled chronic condition according to the judgment of the investigator. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Proportion of participants with positive IGRA, per site, calculated using the per protocol population.   IGRA status (positive/negative/indeterminate)
at screening (i.e) Day 1  
 
Secondary Outcome  
Outcome  TimePoints 
1. Proportion of participants with positive IGRA, summarized by age group (15 to 24 [inclusive], and
25 to 34 years of age [inclusive]) per site.
2. Incidence rate of suspected pulmonary TB, summarized overall.
3. Incidence rate of laboratory-confirmed pulmonary TB, summarized overall. 		 1. Time Frame: Screening
2. Time Frame: Day 1 up to 30 months
3. Time Frame: Day 1 up to 30 months 
 
Target Sample Size   Total Sample Size="7520"
Sample Size from India="320" 
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   N/A 
Date of First Enrollment (India)   15/01/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/12/2021 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="6"
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 Yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response (Others) -  Participant data will only be shared in aggregate

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response (Others) -  Anyone will be able to view the shared aggregate data

  4. For what types of analyses will this data be available?
    Response (Others) -  The shared data can be used for any purpose

  5. By what mechanism will data be made available?
    Response (Others) -  Data will be available via India CTRI and/or ClinicalTrials.gov

  6. For how long will this data be available start date provided 01-10-2024 and end date provided 01-10-2037?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   The purpose of this study is to conduct a multi-country, multi-site, epidemiologic study designed to assess the proportion of interferon gamma release assay (IGRA) positivity, at site level, and to build capacity to conduct a future TB vaccine efficacy study 
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