Mission & History

RePORT India

RePORT India (Regional Prospective Observational Research for Tuberculosis) is a bilateral, multi-organizational, collaborative research effort established in 2013 under the Indo-U.S. Vaccine Action Program (VAP).

RePORT India is now the largest of six regional consortia – China, Brazil, Indonesia, Philippines, and South Africa are also undertaking multi-organizational tuberculosis (TB) research efforts. Each RePORT consortium is designed to support local, in-country, TB-specific data and specimen biorepositories and associated research. Taken together, the anticipated results include greater global clinical research capacity in high-burden settings and increased local access to quality data and specimens for members of each consortia and their domestic and international collaborators. Leveraging the data, specimens, infrastructure, and scientific partnerships established by RePORT India in Phase I, the consortium has now launched Phase II.

Our Mission

RePORT India is charged with

1

Advancing

regional TB science in India, towards fulfilling the TB strategic goals of the country

2

Strengthening

TB research capacity and infrastructure

3

Fostering

research collaboration within India and with other countries focused on research that can lead to clinically important biomarkers, vaccines, drugs, and diagnostics

Phase I

2013 – 2018

Phase I (2013–18) commenced with six Clinical Research Sites (CRSs) in Western and Southern India that were partnered with five U.S. academic institutions. P.D. Hinduja Hospital and Medical Research Centre was subsequently added as the seventh Indian site. Initially, each site had its own “Parent Protocol” with distinct research topics. In 2017, RePORT India launched the “Common Protocol” with standardized data elements and harmonized procedures for enrollment. Under the Parent and Common Protocols, CRSs established prospective observational cohorts of participants from whom specimens were collected:

Cohort A

Participants who have active TB disease. Studies involving this cohort of patients focus on TB diagnosis and treatment outcomes.

Cohort B

Participants who are household contacts (HHCs) of an active case of TB. Studies involving this cohort of patients focus on risk of infection and progression to TB disease after exposure.

Phase I Protocols

Parent Protocols – CSR Specific Objectives

Each CRS is connected to one or more laboratories where they house their Parent Protocol data and samples at their respective India-based institutions. Samples collected under RePORT India Site-Specific Parent Protocols are kept separate from the Phase I and Phase II Common Protocol samples.

 

Parent Protocol Study Topics

BMMRC & UTT

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

BJGMC, NIRT, & JHU

Host and Microbial Factors Associated with Poor Treatment Response and Progression to Active
TB (C-TRIUMPH)

CMC Vellore & Univ of Washington / Univ of Cambridge

Host Determinants in the Eicosanoid Pathway that Modulate the Inflammatory Response,
Disease Outcome, and Treatment Responsiveness in TB

Hinduja & JHU

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

JIPMER, BU/BMC, & Rutgers

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

MVDRC, NIRT-ICER, & UMass

Effects of Diabetes and Prediabetes on TB Severity

Common Protocols – RePORT India-Wide Objectives

The primary objective of the Phase I Common Protocol was to provide data and specimens to Indian biomarker researchers and collaborators to better understand:

  1. Prognosis of TB disease
  2. Pathogenesis of progression from TB exposure to disease

A RePORT India Central Biorepository was established at the National Institute of Research in Tuberculosis (NIRT) in Chennai led by Dr. Hanna Luke Elizabeth.

In addition, a Statistical Data Management Center was established at the Society for Applied Studies (SAS) – Centre for Health Research and Development (CHRD) in New Delhi, and Pharmaceutical Product Development, LLC (PPD) was contracted to provide Common Protocol technical support.

Phase II

2021

Under a Phase II Common Protocol, we are pursuing five specific scientific aims including the following cohorts:

Diagnostic

New TB suspects

Cohort A

Active TB disease

Cohort B

HHCs

Samples collected under this protocol will be curated, stored, and managed at the RePORT India Central Biorepository at NIRT where Phase I Common Protocol samples are currently stored. A data management center is being established at JIPMER in Puducherry and PPD will continue to provide technical support. The consortium has now been expanded to include two new CRSs in Northern India.

North Eastern Indira Gandhi Regional Institute of Health & Medical Sciences (NEIGRIMHS)

  • Location: Shillong, India
  • Principal Investigator: Dr. Valarie Lyngdoh
  • Linked to: JIPMER

Postgraduate Institute of Medical Education and Research (PGI)

  • Location: Chandigarh, India
  • ​Principal Investigator: Dr. Ashutosh N Aggarwal
  • Linked to: CMC Vellore

Executive Committee’s Mission 

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Set Research Priorities

Guide Scientific Activities

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Offer Administration & Logistics in Support of Research Priorities

Funding

The RePORT India Consortium is supported with bilateral funding from the Government of India’s (GOI) Department of Biotechnology (DBT) and the U.S. National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS), and Office of AIDS Research (OAR). CRDF Global administers and oversees the funding from the U.S. government.