On this year’s World TB Day, EDCTP joins the global health community in a call to urgently raise investments to achieve the commitments to end TB made by global leaders. Although funding towards TB research and development did not decrease as significantly as expected during the COVID-19 pandemic, it is still below half of the $2 billion annual financing target committed to by governments at the United Nations General Assembly High-Level Meeting on TB in 2018. In recognition of this chronic underfunding, EDCTP has made substantial investments in TB research and, together with our partners, recently launched the Global TB vaccine R&D roadmap and published several tools to accelerate TB vaccines R&D.
“EDCTP remains committed to investing in TB research & development, part of the jigsaw to end TB. We are making palpable investments – and aspire to do more – towards clinical development of short and effective treatments for all forms of TB, prognostics and diagnostics deployable at point-of-care, as well as vaccines based on different modes of action”
Michael Makanga, EDCTP Executive Director
In its strategic business plan for 2014-2024, EDCTP has identified important areas of unmet medical need for each of its target disease areas as well as for research capacity development. Important goals for TB research include:
Find new approaches for early diagnosis of active TB
Shorten the duration of therapy, where appropriate
Improve treatment for both drug-sensitive and drug-resistant TB, which will prevent relapse, reduce the emergence of drug resistance, and prevent long-term lung damage and latent TB infection progressing to active TB.
Ultimately, TB control will require affordable, short, effective and well-tolerated treatments for all forms of TB (i.e., latent TB infection, drug-susceptible and drug-resistant TB disease), point-of-care diagnostic tests able to characterise drug resistance, and an effective vaccine.
“Affordable and accurate point-of-care diagnostics for TB are urgently needed, and we should increase access of vulnerable populations to life-saving diagnosis and treatment. Preventing TB and shortening the duration of treatment also remain a priority in our strategic research agenda to End TB.”
Harleen Grewal, University of Bergen and member of the EDCTP Scientific Advisory Committee
Between 2014 and 2021, EDCTP has invested EUR 213.50 million in TB clinical trials, capacity building and talent development:
Second largest public funder of TB research
In the 2021 Report on TB Research Funding Trends, an annual publication of Treatment Action Group, EDCTP was identified as the second largest public funder of TB research and the third largest funder of TB research overall. Between 2019 and 2020, our investments in TB research doubled from EUR 24 million to EUR 51 million, a tangible effort to invest in ending TB and saving lives.
In the summary of the report, where TAG outlines the pathway the EU can take to scale up support for TB R&D, it states: “A comparison of funding from 2019 and 2020 shows an increase in overall investments in spite of the economic shocks of the COVID-19 pandemic. However, this increase is due primarily to a doubling of spending by the European & Developing Countries Clinical Trials Partnership (EDCTP); like in the United Kingdom, investments from many other European countries in 2020 decreased.”
Overcoming key barriers to TB vaccine R&D and implementation
In addition to its investments in TB, EDCTP and the Amsterdam Institute for Global Health and Development (AIGHD) launched the Global TB vaccine R&D roadmap, also published in The Lancet. It identifies priorities for the development and implementation of new TB vaccines with the aim to coordinate and accelerate global action. The project was carried out in close collaboration with the World Health Organization.
The consultation led to the identification of three priorities: 1) diversify the pipeline; 2) accelerate clinical development; and 3) ensuring public health impact. Three cross-cutting enabling factors were also identified: funding, open science and stakeholder engagement.
“An effective vaccine against tuberculosis is an attainable goal if we invest much more in discovery and clinical research, use that funding in a clever way, share our findings and specimens, and already think now how such a vaccine should be delivered to reach maximum health impact. The unprecedented acceleration of vaccine development we have seen for COVID-19 should be the new normal – let’s not settle for less.”
Frank Cobelens, Amsterdam Institute for Global Health and Development, Lead author of the TB vaccine R&D Roadmap
EDCTP has awarded €51.18 million to support the development of TB vaccines through four collaborative research projects supporting vulnerable populations – newborn infants and adolescents:
POR TB (coordinated by Statens Serum Institute, Denmark): this consortium assesses whether the TB vaccine H56:IC31 can protect against recurrent TB through a phase IIb trial conducted at six sites in South Africa and one in Tanzania. Recruitment has been completed and a total of 831 patients have been included in the trial.
priMe (coordinated by Vakzine Projekt Management GmbH, Germany): this phase III trial evaluates VPM1002 vaccine (recombinant BCG vaccine) in Gabon, Kenya, South Africa, Tanzania, Uganda. By October 2021 50% of newborns have been recruited.
MTBVAC – Newborns (coordinated by Biofabri SL, Spain): this phase IIa trial evaluates the Efficacy, Safety and Immunogenicity of MTBVAC administered in healthy HIV unexposed uninfected and HIV exposed uninfected newborns in Tuberculosis-Endemic Regions of Sub-Saharan Africa. Last baby of the trial has performed the last visit a year after the vaccination.
MTBVACN3 (coordinated by Biofabri SL, Spain): this phase III trial will have the official kickoff meeting in May 2022.
To enhance the coordination and collaboration between these projects and future EDCTP TB vaccine-funded research, EDCTP initiated a coordination project that is being implemented by the TuBerculosis Vaccine Initiative (TBVI). The overall goal of the project is to maximise the output and impact of the research funded by EDCTP while contributing to the development of EDCTP’s strategy and the global TB vaccine portfolio.
“New TB vaccines are essential for the world to meet its goals to end the TB pandemic. TBVI and EDCTP closely collaborate with vaccine developers on essential tools that enable them to better manage their vaccine development processes more effectively and efficiently. With these tools, we can accelerate the development of promising TB vaccine candidates and further innovate and diversify the TB vaccine pipeline.”
Nick Drager, Executive Director Tuberculosis Vaccine Initiative (TBVI)
EDCTP is also an official endorser of the call for increased EU funding for TB vaccine development made on behalf of the TB community. The statement, as well as two letters directly addressing European officials, was jointly prepared by the TB Vaccine Advocacy Roadmap (TB Vax ARM,) a global coalition of over 90 civil society organisations representing TB researchers, clinicians, patients and allies.
TB: Recent EDCTP prizes
In October 2021, EDCTP awarded three prizes to TB-related researchers and research consortia:
The Dr Pascoal Mocumbi prize was awarded to Professor Sir Alimuddin Zumla. Sir Ali Zumla is ranked as the world’s top communicable diseases expert and has authored 22 medical textbooks and contributed to 800 publications worldwide. He has a special interest in HIV/AIDS, respiratory infections (including COVID-19 and Tuberculosis), and poverty-related diseases. Sir Ali is renowned for his empowerment of African and European scientists. Professor Zumla upon accepting the Dr Pascoal Mocumbi prize: “It’s been a pleasure to work with and also mentor a range of senior and younger generation scientists, doctors, laboratory staff, community groups, policy makers, charities and faith groups across Africa, Europe and the Middle East. I dedicate this prize to them all.”
The EDCTP Outstanding Research Team prize was awarded to the African-European Tuberculosis Consortium (AETBC), an international multi-site group of African and European researchers to investigate the use of host biosignatures for the diagnosis of active TB disease. Professor Gerhard Walzl of AETBC upon accepting the EDCTP Outstanding Research Team prize: “I think the success of the AETBC shows that African institutions can lead international research effectively.”
The EDCTP Scientific Leadership prize was awarded to Professor Graeme Meintjes. Over the past 20 years, Prof. Meintjes has made huge contributions to the improved understanding of HIV-associated tuberculosis, tuberculosis immune reconstitution inflammatory syndrome, and HIV-associated cryptococcal meningitis. Professor Meintjes upon accepting the EDCTP Scientific Leadership prize: “This prize is an inspiration to me to contribute to capacity building and conduct research on infectious diseases in Africa.”