About the POR TB Consortium
Over the last two centuries, tuberculosis (TB) is estimated to have killed one billion people, and remains the world’s most lethal infectious disease. The TB epidemic is responsible for economic devastation and a cycle of poverty and illness that entraps families, communities and even entire countries. Among the most vulnerable and underserved populations are women, children, and those with HIV/AIDS. The burden of TB is largely borne by just 30 countries, 16 of which are in sub-Saharan Africa. There is growing bacterial resistance to available drugs, which means the disease is becoming more difficult to treat. In 2016 there were an estimated 558,000 cases of multi-drug resistant (MDR-) TB in 2016.
The current tools for controlling TB are clearly insufficient, and without new efficacious TB vaccines, the 2035 World Health Organization’s End TB strategic goals of a reduction of TB deaths and cases of TB disease will not be met, nor will the target within the United Nations Sustainable Development Goals of ending TB by 2030.
TB vaccines are expected to be equally effective against drug-resistant ands drug-sensitive strains of TB and therefore, intervention using vaccines is critical for managing the spread of resistant strains and decreasing the need for antibiotics.
The Prevention of Recurrence (POR) Consortium is multidisciplinary and brings together six African and two European research organizations to address the global TB emergency through development of a safe, effective, accessible vaccine to prevent TB and stop transmission.
Specifically the POR consortium aims to:
- Accelerate the clinical development of the leading TB vaccine candidate (H56:IC31) by conducting a phase 2 Prevention of Recurrent TB vaccine trial in Tanzania and South Africa
- Support capacity development to expand TB vaccine clinical trial and laboratory expertise in Sub-Saharan Africa
- Advance understanding of mechanisms of TB vaccine reactogenicity, immunogenicity and efficacy
The work for these three objectives in five interrelated work packages (WP)
- WP1. Project management, led by Statens Serum Institut
- WP2. Prevention of recurrence trial, led by Aeras Africa
- WP3. Enhancing TB vaccine trial capabilities and networking, led by Aeras Africa
- WP4. Advance understanding of mechanisms of reactogenicity, immunogenicity and efficacy, led by SATVI, South Africa
- WP5. Vaccine manufacture, led by Statens Serum Institut
A POR trial represents a significant advancement in TB vaccine development, as POR studies are a faster, less expensive method for triaging the multiple TB vaccines in development than having to conduct prevention of TB disease trials in the healthy population. The results of this trial will also inform the decision to progress the H56:IC31 TB vaccine candidate into late stage development for a prevention of TB disease indication in the broader population. If H56:IC31 is efficacious in preventing TB recurrence this is a licensable indication in and of itself, and could support investigating H56:IC31 immunotherapy for prevention of recurrences of drug-resistant, as well as drug-sensitive TB, and as an adjunct to TB chemotherapy to shorten treatment duration.
The consortium is funded by the European Union under the The European & Developing Countries Clinical Trials Partnership (EDCTP) program