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Tuberculosis (TB) is one of the top 10 causes of death around the globe and killed 1.7 million people in 2016, according to the World Health Organization. Spread through the air, it takes just a sneeze or cough to pass from one person to the next. Most fatalities occur in poorer countries, and TB is also a leading killer of people who are HIV-positive.
To date, no fully effective TB vaccine exists and – despite being both preventable and curable – it can be difficult for those afflicted with the disease to get life-saving care. Current treatment can involve taking antibiotics for up to two years, potentially becoming a financial burden and resulting in patients stopping their medication. At times, TB is not diagnosed and dealt with in a timely manner, or the necessary drugs are not available. Complicating matters further is the development and spread of drug-resistant TB strains.
Faced with these challenges, the EU-funded TBVAC2020 project is working to develop a variety of vaccines to prevent people from catching TB, boost immunity against the disease and shorten the duration of treatment for those who do get sick.
“The aim of TBVAC2020 is advancing novel and promising TB vaccine candidates from discovery to preclinical and early clinical development,” says Daniëlle Roordink of the Tuberculosis Vaccine Initiative in the Netherlands, the project coordinator. “It has been successful in generating a large set of new insights and concepts, including new vaccine approaches, new preclinical models, experimental medicine and biomarkers.”
Pipeline with promise
Consisting of 42 partners, TBVAC2020 aims to accelerate the development of novel TB vaccines by pinpointing the most promising as early as possible and providing these with both support and guidance to maximise their potential. This has resulted in an uptick in the number of candidates making their way through the long and arduous process – known as the vaccine pipeline – aimed at bringing them onto the market.
“A main result of the efforts of this consortium is the diversification of the TB vaccine pipeline,” says Stefan Kaufmann, chair of TBVAC2020’s steering committee. “That is, from only a few TB vaccine candidates in the pipeline 15 years ago to currently more than 25 candidates in early development and 13 candidates being evaluated in clinical stages.”
Specifically, key achievements as of March 2018 include the development of seven innovative TB vaccine approaches showing promising results in preclinical evaluation studies, as well as nine novel concepts and strategies that will accelerate the design of next-generation vaccine candidates. In early clinical development, one candidate was selected for a phase 1 trial.
A particularly promising example of how the TBVAC2020 consortium works is the MTBVAC vaccine candidate. First developed by university researchers, it went through preclinical studies conducted via a previous TBVAC consortium and is now being developed further by a manufacturer.
It has shown to induce an immune response in newborns and researchers say it could be more effective than the currently used BCG vaccine often given to infants in countries with a high prevalence of TB.
Innovative ideas
TBVAC2020, which builds upon similar EU-funded projects over the past decade and a half, emphasises collaboration with top research institutions in the EU and internationally. It involves both the open sharing of results and research test facilities where potential vaccines can be evaluated and compared. And an independent team of both product and clinical experts is on hand to provide guidance and advice.
“This combination of scientific research and product development collaborations in such a big consortium is unique,” Roordink says.
In trying to understand the complexities of TB, TBVAC2020 also attempts to think outside the box.
“We always try to look at new ways to trigger the immune system, also new technologies and new ways of vaccine administration” such as exploring delivery directly into the lungs in order to get a better immune reaction, says Roordink.
“We try to be innovative.”