DJ Christopher, D.N.B.RePORT India Chair and RePORT International EC Member

Principal InvestigatorChristian Medical College, Vellore

Department of Pulmonary Medicine

RePORT India

RePORT India: Network Characteristics

• Joined RePORT International in 2013 (MOU signed in 2017)

• Funding provided by:

– Government of India’s Department of Biotechnology (DBT) and the Indian Council of Medical Research (ICMR)

– National Institute of Allergy and Infectious Diseases (NIAID/NIH)

• The repository for specimen storage is located at the National Institute for Research in TB (NIRT) in Chennai, India

• The statistical and data management center is located at the Society for Applied Studies (SAS)-Centre for Health Research and Development (CHRD) in New Delhi, India

RePORT India Site Locations

Chennai

• National Institute of Research in TB (NIRT)

• MV Diabetes Research Centre (MVDRC)Vellore• Christian Medical College (CMC) VellorePondicherry• Jawaharlal Institute of Postgraduate

Medical Education and Research (JIPMER)

Pune• Byramjee Jeejeebhoy Government

Medical College (BJGMC) Hyderabad• Bhagwan Mahavir Medical Research

Centre (BMMRC)Mumbai• Hinduja Hospital

PIs & Parent Protocol Topics of Study

Principal Investigators

Topic of StudyIndia U.S.Dr. Padma Chandrasekaran, NIRTDrs. Vidya Mave and Samir Joshi,

BJGMC

Dr. Amita Gupta, Johns Hopkins University (JHU)

Host and Microbial Factors Associated with Poor Treatment Response and Progression to

Active TB

Dr. Vijay Viswanathan, MVDRC Dr. Hardy Kornfeld,University of Massachusetts

Effects of Diabetes and Prediabetes on TB Severity

Dr. DJ Christopher, CMC Vellore Dr. Lalitha Ramakrishnan, University of Cambridge

Host Determinants in the Eicosanoid Pathway that Modulate the Inflammatory Response,

Disease Outcome and Treatment responsiveness in TB

Dr. Vijaya Valluri, BMMRC Dr. Krishna Vankayalapati, University of Texas, Tyler (UTT)

Immunologic Markers of Persons at Highest Risk of Progression of Latent TB Infection to TB

Drs. Subhash Parija, Gautam Roy, and Sonali Sarkar, JIPMER

Dr. Jerrold Ellner, Boston Medical Center (BMC)

Biomarkers for Risk of TB and for TB Treatment Failure and Relapse

Hinduja Hospital Dr. Amita Gupta, Johns Hopkins University (JHU)

MDR-TB Treatment Outcomes, Adverse Effects, Mtb Genotyping, and Pharmacokinetic Testing

Parent Protocol Status: Cohort A

Site name

Date started enrollment

# Enrolled/ target (%) On follow-up*(%)

Known endpoints

NIRT Aug2014

349/500(70%)

326/349(93%)

Failures** - 49, Recurrence -12, Death - 10 (June 2017 data)

BJGMCAug2014

479/500(96%)

441/479(92%)

Failures** – 28, Recurrence –12, Death – 13 (June 2017 data)

MVDRCJuly

2014383/450

(85%)299/383

(78%)Failures – 9, Recurrence –15,

Death - 10

CMCSept2014

PTB - 69/200(35%)

PTB - 59/69(86%)

Failures – 4, Recurrence - 0Death - 2

TBM - 142/200(71%)

TBM - 109/142(77%)

Death - 17

JIPMERMay2014

917/1100(83%)

884/917(96%)

Failures – 16, Recurrence- 8Death – 29

HindujaEst. Nov

2017XX/200 - -

*On follow-up = includes patients who completed study**Failures = Confirmed (positive on 2 cultures at 6 months) and probable (positive on 1 culture and clinical symptoms)

Parent Protocol Status: Cohort B

Site name Date started

enrollment

# Enrolled/ target (%)

On follow-up*(%)

Known endpoints

NIRTAug

2014551/700

(79%)530/551

(96%)Incident TB - 11

(June 2017 data)BJGMCAug

2014499/700

(71%)438/499

(88%)

JIPMER May2014

1428/1500(95%)

1396/1428(98%)

Incident TB - 2,Co-prevalent - 7

BMMRC June2014

752/1500(50%)

584/752(78%)

Incident TB - 8(July 2017 data)

Hinduja Est. Nov 2017

XX/60 - -

*On follow-up = includes patients who completed study

Common Protocol Status

Site name Date started

enrollment

# Enrolled/ target

(%)

NIRT July 2017 8/325(2.5%)

BJGMC April 2017 49/325(15.2%)

MVDRCActivated

August 2017

XX/120(0%)

JIPMERActivated

September 2017

XX/750(0%)

CMC TBD XX/180(0%)

Cohort A

Site name Date started

enrollment

# Enrolled/ target

(%)

NIRT July 20178/1290(0.6%)

BJGMC April 201741/1290(3.2%)

JIPMERActivated

September 2017

XX/1020

BMMRC TBDXX/1500

Cohort B

RePORT India Studies

• Cross-consortium Studies (International) – Molecular Signatures of Tuberculosis-Diabetes Interaction (MSTDI) - MVDRC, UMass,

BJGMC, NIRT, JHU, RePORT International

– Validation of Transcriptional Signature to Predict Active TB Disease among Advanced HIV Patients - BMC, BJGMC, JHU, RePORT Brazil

• Comparison of available purified-protein derivative (PPD) tuberculin skin test (TST) antigen solutions in detecting latent tuberculosis infection in India - CMC,

BJGMC, JIPMER, BMMRC, NIRT, JHU, BMC• Status:

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RePORT India Publications (2015 – 2017)

• Effect of TB Rx on T-cell homeostasis in TB-DM. Kumar NP1

et al. Immunology. 2016• Kornfield H et al. High Prevalence

and Heterogeneity of DM in South India. Chest: 2016.

• Cesar A. et al. Immunology of DM-TB reveals Signatures of Disease Complications. Nature 2017

Banked Samples

Common Protocol

Number of aliquots

Cohort A Cohort B

PBMCs 143 72

Whole blood (DNA)

49 32

Urine 53 28

Plasma 99 56

Parent Protocols

Number of aliquots

Cohort A Cohort B

PBMCs 5,311 3,843

Whole blood (DNA)

960 3,428

Urine 16,250 10,927

Plasma 23,171 18,832

Updated Aug 31, 2017 Updated Jan 17, 2017

We have site specific parent protocol samples & common protocol samples

RePORT India: Future Data or Sample Sharing

• TB-DM research has become a major consortium priority-RICC inter-consortium project

• Huge repository for host & microbial biomarkers study- immunology of progression, resistance, Rx outcomes, & Omic studies

• One vaccine study on the verge of commencing, ID 93 vaccine study in the pipe line

RePORT India Consortium Team

THANK YOU!