PROTECT-TB

A Phase III, randomised, double blind, three arm placebo controlled trial to evaluate the efficacy and safety of two vaccines VPM1002 and Immuvac (Mw) in preventing Tuberculosis (TB) in healthy household contacts of newly diagnosed sputum positive pulmonary TB patients

ICMR Approved Site

Apex Body Selection

4 Core Areas

Staff Training Focus

Household-Level Outreach

Trial Readiness

Overview

The Indian Council of Medical Research (ICMR) the apex governing. body in India for the formulation, coordination and promotion of biomedical research selected SHARE INDIA and MediCiti Institute of Medical Sciences (MIMS) as s sub site of Bhagwan Mahavir Medical Research Center (MMMRC) for a vaccine study.

Aim

To support the effective implementation of a TB vaccine trial by strengthening site capacity, enhancing community engagement, and promoting awareness through training of study personnel, development of recruitment and retention strategies, and assessment of community preparedness among household contacts of index TB patients.

Objectives

To support the training of study site personnel about the protocol, GCP, biosafety and risk benefits.
To develop site specific recruitment and retention strategies.
To understand the community preparedness or willingness for participation in the trial for the benefit of the household contacts of Index TB patients.
Sensitizing community peers and creating awareness about the TB Vaccine trial.

Status of the project

The SHARE INDIA site was initiated on 13th July 2020 and has successfully enrolled 219 participants, who are being followed up as per the protocol timelines.
All participant visits have been completed as per the schedule and in accordance with the directions of ICMR.
Data analysis is currently in progress and is being carried out by ICMR.