TB: Commitments/Vaccines/Strategies

Milestones :: Perspectives

TB: Commitments/Vaccines/Strategies

World leaders commit to bold targets and urgent action to end TB

26 September 2018  News Release

World leaders meeting today at the United Nations (UN) General Assembly have committed to ensure that 40 million people with tuberculosis (TB) receive the care they need by end 2022. They also agreed to provide 30 million people with preventive treatment to protect them from developing TB.

“Today is a landmark in the long war on TB,” said Dr Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization. “These are bold promises – to keep them partnership is vital. WHO is committed to working with every country, every partner and every community to get the job done.”

Heads of state and government attending this first-ever UN High-level meeting on TB agreed to mobilize US$ 13 billion a year by 2022 to implement TB prevention and care, and US$ 2 billion for research. They committed to take firm action against drug-resistant forms of the disease; build accountability and to prioritize human rights issues such as the stigma that still prevails around TB in many parts of the world.

They acknowledged that the current rate of progress was endangering prospects of meeting global targets to end TB. Today, TB remains the world’s deadliest infectious disease: it killed 1.6 million people in 2017, including 300 000 people with HIV. In the same year, 10 million people fell ill with TB.

“The political declaration proposed for this meeting sets a roadmap for accelerated action to end TB in line with the vision and targets for 2030,” said H.E. Ms Maria Fernanda Espinosa Garcés, President of the 73rd Session of the UN General Assembly. “We have before us the opportunity for a clear win – a chance to save the lives of millions, to preserve billions in resources, to demonstrate the success of the Sustainable Development Goals, and to reaffirm the utility, efficacy and necessity of multilateralism and the UN System. Let us not miss this opportunity.”

The political declaration is the culmination of recent leadership commitments at global and regional level – including the 2017 Moscow Declaration to End TB – to drive universal access, sufficient and sustainable financing, intensified research and innovation, and accountability across all sectors.

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GSK candidate vaccine helps prevent active pulmonary tuberculosis in HIV negative adults in phase II study

Publication of primary results in the New England Journal of Medicine shows positive impact of innovative vaccine technology in clinical trial conducted in tuberculosis endemic regions

LONDON (25 September 2018) – Today, GSK and Aeras reported that GSK’s M72/AS01E[1] candidate vaccine significantly reduced the incidence of pulmonary tuberculosis disease in HIV-negative adults with latent tuberculosis infection[2] in an ongoing phase IIb clinical trial testing. These primary results published in the New England Journal of Medicine after two years of trial demonstrate an overall vaccine efficacy of 54%, with varied response rates observed in different demographic sub-groups. The candidate vaccine had an acceptable safety and reactogenicity profile.

Tuberculosis is the leading cause of death through infectious disease worldwide and represents a significant public health threat with 1.6 million attributed deaths in 2017. It is estimated that one-quarter of the global population has latent tuberculosis infection, of whom approximately 10% will develop active pulmonary tuberculosis disease.  Currently, multi-drug resistant strains of tuberculosis are emerging globally, and the only currently available vaccine against tuberculosis, BCG, does not provide proven and consistent protection in adults in tuberculosis endemic countries. Without a more effective vaccine, it will not be possible to achieve the WHO target of decreasing the number of new cases by 90% and the number of tuberculosis deaths by 95% between 2015 and 2035.

Dr Emmanuel Hanon, Senior Vice-President and Head of R&D, Global Vaccines GSK, said: “These initial findings represent a significant innovation in the development of a new and much-needed vaccine and advance the scientific understanding of tuberculosis. This scientific breakthrough – one of the very few in tuberculosis vaccine development for almost 100 years – has been made possible by our strategic partnership with Aeras, in which GSK is providing the innovation expertise and technology platforms, such as the proprietary AS01 adjuvant.”

The study assesses the safety and efficacy of M72/AS01E protecting adults with latent tuberculosis infection against developing pulmonary tuberculosis disease. The ongoing trial is conducted in tuberculosis endemic regions (Kenya, South Africa and Zambia) and involves 3,573 HIV-negative adults. For this analysis, participants who received two doses of either M72/AS01E or placebo 30 days apart have been followed up for at least 2 years to detect evidence of pulmonary tuberculosis disease.  In the vaccine group, 10 participants developed active pulmonary tuberculosis compared to 22 participants in the placebo group.

Jacqui Shea, Chief Executive Officer of Aeras, which contributed to the partnership their decades long experience in tuberculosis vaccine clinical development, clinical operations capabilities and strong links with African clinical sites and patient communities, said: “This ground-breaking study shows – for the first time – that a subunit vaccine can significantly reduce the incidence of pulmonary tuberculosis in healthy, HIV-negative adults with latent tuberculosis infection, and that more effective vaccines against tuberculosis are achievable. Given the overwhelming public health need, the importance of these promising results, which need to be confirmed through additional clinical research, cannot be overstated. An effective vaccine, able to reduce transmission, would be by far the most impactful new intervention to end the global tuberculosis epidemic”.

The study is still ongoing and a final analysis including all efficacy, safety, reactogenicity and immunogenicity data will be performed in 2019 after all participants have completed three years of follow up.

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NIH releases strategic plan to address tuberculosis research

September 26, 2018 — TB is the leading infectious cause of death worldwide.
Recently, the global health community has strengthened its efforts and resolve to tackle this ancient disease. Writing in the Journal of the American Medical Association, Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, details the institute’s new strategic plan for building on these current efforts by furthering the understanding of TB and developing and applying cutting-edge tools to fight the disease.

The NIAID Strategic Plan for Tuberculosis Research prioritizes expanding fundamental knowledge of TB by using modern tools, such as state-of-the-art imaging and systems biology methods, to better understand how TB infection remains latent in some individuals and then progresses to active disease, as well as the host and microbial factors that affect TB disease, transmission, and epidemiology.  The plan is being released to coincide with the United Nations General Assembly High-Level Meeting on Ending TB on September 26…