PreVenTB trial: protocol for evaluation of efficacy and safety of two vaccines VPM1002 and Immuvac (Mw) in preventing tuberculosis (TB) in healthy household contacts of newly diagnosed sputum smear-positive pulmonary TB patients: phase III, randomised, double-blind, three-arm placebo-controlled trial

PreVenTB Trial Overview

The PreVenTB trial is a major study testing the effectiveness and safety of two TB vaccines, VPM1002 and Immuvac (Mw), to prevent tuberculosis (TB) in healthy individuals living with newly diagnosed TB patients. This is a Phase III, randomized, double-blind, placebo-controlled trial taking place in India.

Why This Study Matters

TB is a serious infectious disease that poses a significant risk worldwide. New preventive strategies, including effective vaccines, are urgently needed to combat this health crisis.

Study Details

The trial will involve 12,000 healthy household contacts (HHCs) aged 6 to 99 years. Participants will receive one of the following:

  • VPM1002 vaccine
  • Immuvac (Mw) vaccine
  • Placebo

Key Objectives

  • Primary goal: Prevent microbiologically confirmed TB.
  • Secondary goals include:
    • Preventing latent TB infection.
    • Monitoring adverse events in participants.
    • Assessing how effective the vaccines are across different age groups.
    • Evaluating immune responses to the vaccines at specified intervals post-vaccination.

Ethics and Accountability

The study has received ethical approvals from various respected institutions. Results will be shared transparently through publications, conferences, and communications with health authorities.

Trial Registration

This trial is registered under the number: CTRI/2019/01/017026.

The Importance of Clinical Trials

Clinical trials are essential for creating safe and effective medical treatments. They help translate research findings into daily medical practices.

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