Prevention of Tuberculosis Recurrence Consortium launched in Cape Town, South Africa
The Prevention of Tuberculosis Recurrence Consortium (POR-TB Consortium) was launched in Cape Town, South Africa on 12-13th March 2018. EDCTP is investing €13.8 million in the consortium, which is coordinated by Professor Peter L. Andersen of Statens Serum Institute in Copenhagen, Denmark. The kick-off meeting was attended by 22 representatives from the 8 consortium partners and EDCTP, and included both a conference and a site visit.
Objectives of POR TB consortium
The overall aim of the consortium is to unite six African and two European leading research institutions, clinical trial sites and vaccine developers in a consortium to conduct a novel innovative and cost-effective TB vaccine efficacy trial. The trial will use prevention of TB recurrence after TB treatment as an indicator for the ability of a vaccine to prevent TB disease in the broader population, and is the first of its kind to be investigated.
“With the increasing incidences of multi-drug-resistant forms of TB, we need to accelerate all medical interventions aimed at improving prevention, diagnosis and treatment of TB, especially in high risk populations. I am convinced that the evaluation of this novel multistage vaccine concept which has preventive and therapeutic potential, is a worthwhile investment.”
Dr Michael Makanga, EDCTP Executive Director.
The consortium will enroll 900 participants at the end of active TB treatment, randomized to receive either placebo or the H56:IC31 vaccine from Statens Serum Institut. Study participants will be followed up for 12 months after vaccination, to assess the vaccines ability to prevent the 4-8% recurrent TB normally seen after treatment.
“In this trial we implement a novel trial concept for the first time. Based on a solid preclinical assessment of this vaccine in several animal models combined with a very promising safety profile in humans, we are confident we give this new concept the best chance for success. If we are able to show vaccine efficacy, it will be a game changer in the TB vaccine field, providing valuable proof of concept for therapeutic use of TB vaccines, a major achievement in the fight against this high priority disease.”
Peter Andersen, Director, Statens Serum Institute.
Aligned with the vaccine trial, the consortium will focus on capacity development and harmonisation of clinical trial sites, with the aim to expand TB vaccine clinical trial and laboratory expertise in Sub-Saharan Africa, in preparation of future larger efficacy assessments of TB vaccines.
In parallel, the scientists will develop an ambitious biobank allowing in-depth studies to advance understanding of mechanisms of reactogenicity, immunogenicity and efficacy of the H56:IC31 vaccine and TB recurrence.
About the H56:IC31 vaccine
The H56:IC31 vaccine is based on a novel multistage vaccine concept targeting different stages of infection and is supported by a very extensive preclinical animal model data package to support both its preventive and unique therapeutic effect. H56:IC31 is developed by SSI, using the IC31® adjuvant available under license from Valneva. H56:IC31 has been assessed in five human trials, providing supporting data that H56:IC31 is well tolerated and immunogenic in Mtb-infected individuals, in patients following cure of active TB, and in uninfected individuals.
About the POR TB consortium
The organizations participating in the consortium are
- Statens Serum Institute, Denmark
- Aeras Africa, Cape Town, South Africa
- Ospedale San Raffaele, Italy
- South African Tuberculosis Vaccine Initiative, University of Cape Town, South Africa
- The Aurum Institute, Johannesburg, South Africa
- TASK Applied Science, Cape Town, South Africa
- University of Cape Town Lung Institute, Cape Town South Africa
- Mbeya Medical Research Centre under the National Institute for Medical Research, Mbeya, Tanzania