World TB Day: EDCTP commits EUR 34M to TB vaccine clinical trials
True to the World Tuberculosis Day 2018 theme ‘Wanted: Leaders for a TB-free world’, the European Union and European member states continue to take an important role in fighting this disease. Recently, the European & Developing Countries Clinical Trials Partnership (EDCTP) committed EUR 34 million in funding for four large clinical trials on candidate TB vaccines. This is the largest European investment into clinical development of TB vaccines to date (with two grants signed and two under preparation), and boosts the joint commitment to combat one of the world’s most devastating diseases. The trials will be conducted by 28 research institutions from sub-Saharan Africa, Europe and India.
Despite significant progress over the last decades, TB remains the leading cause of death globally from a single infectious agent, claiming approximately 1.67 million lives in 2016. Though a poverty-related disease, TB is a global threat respecting no borders. The situation has worsened by the development and spread of drug-resistant strains of Mycobacterium tuberculosis (Mtb), the bacterium that causes TB disease. On 20 May 2017, the G20 Health Ministers, meeting in Berlin, Germany, recognised drug-resistant TB as an important threat, acknowledging the need to develop new drugs, diagnostics and vaccines.
“In line with the global and European aim to end TB and address anti-microbial resistance, EDCTP is proud to invest in international collaborative research consortia conducting clinical research & development on new TB vaccine candidates, in addition to other EDCTP investments in TB drugs and diagnostics R&D.”
Dr Michael Makanga, EDCTP Executive Director.
POR TB: prevention of recurrent TB
The POR TB consortium unites six African and two European research institutions, clinical trial sites and vaccine developers to conduct an innovative and cost-effective TB vaccine phase IIb trial to determine efficacy of the multistage vaccine H56:IC31* for prevention of recurrent TB disease.
“The POR TB consortium aims to accelerate TB vaccine development by evaluating a leading candidate in a novel proof-of-concept trial design to facilitate early vaccine development decisions. It also undertakes research capacity development and lays the foundation for phase 3 TB vaccine trials. Importantly, a successful POR vaccine may allow shortening of TB treatment regimens for drug-resistant TB.” Professor Peter Andersen, Statens Serum Institut, Denmark.
EDCTP grant: € 13,788,161
Project partners:
• Statens Serum Institut, Denmark (project coordinator)
• Task Foundation NPC, South Africa
• Ospedale San Raffaele SRL, Italy
• Aeras Global Tuberculosis Foundation NPC, South Africa
• University of Cape Town (UCT), South Africa
• University of Cape Town Lung Institute (PTY) Ltd, South Africa
• Aurum Institute, South Africa
• National Institute for Medical Research – Tanzania (NIMR), Tanzania
* IC31®
priMe: improved version of BCG
The priMe consortium, including 9 African, 5 European, and 1 Indian partner, will conduct a multicenter Phase III double-blind, randomized, controlled trial to evaluate the efficacy and safety of VPM1002 in comparison to BCG in HIV-exposed and HIV-unexposed infants.
“The aim of the development of VPM1002 is to replace BCG by a well-tolerated vaccine that shows efficacy and has a better safety profile. After this pivotal phase III trial, Serum Institute of India Pvt. Ltd., the licence holder of VPM1002 and sponsor of the proposed trial, will apply for market authorization in order to make this novel vaccine available to children in Sub-Saharan countries and worldwide.” Dr Leander Grode, Chief Scientific Officer at Vakzine Projekt Management GmbH, Germany
Estimated EDCTP grant: € 12,493,171
Project partners:
• Vakzine Projekt Management GmbH, Germany (project coordinator)
• TuBerculosis Vaccine Initiative (TBVI), Netherlands
• Swiss Tropical and Public Health Institute (Swiss TPH), Switzerland
• Stellenbosch University, South Africa
• Wits Health Consortium (Pty) Ltd., South Africa
• The University of Cape Town (UCT), South Africa
• Centre de Recherches Médicales de Lambaréné (CERMEL), Gabon
• Ifakara Health Institute (IHI), Tanzania
• Eberhard Karls Universität Tübingen (EKUT), Germany
• Max-Planck-Gesellschaft zur Foerderung der Wissenschaften B.V., Germany
• Uganda National Health Research Organisation (UNHRO), Uganda
• Kenya Medical Research Institute (KEMRI), Kenya
• Makerere University, School of Public Health, Uganda
• Sefago Makgatho Health Science University, South Africa
• Serum Institute of India Pvt. Ltd., India
MTBVAC-Newborns
MTBVAC is a novel TB vaccine candidate based on an attenuated M. tuberculosis. The MTBVAC-Newborns project will support a phase 2a dose-defining study of MTBVAC to evaluate the safety, reactogenicity, immunogenicity, and potential for IGRA conversion and reversion, of MTBVAC in South African newborns.
“Our clinical development consortium will prepare for an infant efficacy trial of MTBVAC by establishing a network of three African sites in South Africa, Senegal and Madagascar. Each site has established research infrastructure. Senegal and Madagascar will, under this proposal, receive immunology laboratory technology transfer and training, and collect crucial TB epidemiological data to enable swift transition into a phase 3 infant trial.” Ingrid Murillo, Clinical research Director of BioFabri, Spain.
EDCTP grant awarded: € 5,537,093
Project partners:
• Biofabri S.L., Spain (project coordinator)
• Stichting TuBerculosis Vaccine Initiative (TBVI), Netherlands
• Universidad de Zaragoza, Spain
• University of Cape Town, South Africa
• Centre de Recherche Biomédicale Espoir Pour La Santé, Senegal
• Institut Pasteur de Madagascar, Madagascar
POI-TB: prevention of TB infection
The POI TB project which is in grant preparation, comprising four African and three European partners, will apply an innovative trial design, prevention of established infection (POI), as a in a phase II efficacy trial to test a lead TB vaccine candidate, H56:IC31. This POI trial aims to establish a new paradigm to facilitate early TB vaccine clinical development decisions, discover potential correlates of protection and/or risk, and building capacity to lay the foundation for phase III TB vaccine trials.
A POI trial requires a smaller sample size and shorter follow-up than a prevention of TB disease trial, making it a time and cost-efficient trial design. The POI-TB trial supports the development of a novel vaccine with potential to markedly impact the burden of a high-priority poverty-related disease in sub-Saharan Africa.
Estimated EDCTP grant: € 2,550,434
Project partners:
• Aeras Global Tuberculosis Foundation NPC, South Africa (project coordinator)
• Statens Serum Institut (SSI), Denmark
• The Aurum Institute, South Africa
• Oslo University Hospital, Norway
• University of Cape Town (UCT), South Africa
• National Institute for Medical Research – Tanzania (NIMR), Tanzania
• University of Bergen, Norway
Summary of EDCTP TB investments
TB research received the largest share of funding in the project portfolio of EDCTP’s first programme, with a total of € 68.96 million (33.2%) for 36 projects. Since the start of the second EDCTP programme in 2014, EDCTP has invested €78.9 million to support 12 large-scale clinical study projects in TB.
More information
• Global report on Tuberculosis Vaccines 2018
• World TB Day 2018 website