Plan to develop new vaccines could help stop TB in our children’s lifetimes
The following is a guest blog post by Dr. Lucica Ditiu, executive secretary of the Stop TB Partnership, commenting on the newly released document Tuberculosis Vaccines: A Strategic Blueprint for the Next Decade, reflecting the consensus of members of the TB vaccine research and development community to develop new vaccines that could help stop TB in our children’s lifetimes.
Some 10 million children have been orphaned by the death of a parent from tuberculosis (TB). That number is shocking, but it does not begin to account for the children who must quit school to care for sick parents, or go to work to keep the family fed, or those who catch TB from a parent or another relative, or those who die from TB without ever accessing proper treatment.
It is unconscionable that in the 21st century any child should die from TB – a curable illness. This year’s World TB Day theme, Stop TB in my lifetime, draws attention to TB’s devastating impact on children and also the vision that today’s youngsters will live to see a world free of TB.
To achieve this goal the world needs a vaccine that is safe and effective for all children and adults. The new vaccine must go way beyond what the only existing TB vaccine –BacilleCalmette-Guérin (BCG) – can do. BCG is used broadly across the world and has considerable value because it protects children against some forms of severe tuberculosis. But it is not safe for children with HIV, and it doesn’t work against pulmonary tuberculosis – the most common and most infectious form of the disease – or in protecting adults.
This month, the TB vaccine research field took a leap forward. Members of the TB vaccine research and development community have come to consensus in a new document titled Tuberculosis Vaccines: A Strategic Blueprint for the Next Decade to coordinate and guide their efforts over the next 10 years. This valuable resource outlines the five key questions that need to be addressed, and provides a basic framework around which both advocates and researchers can organize and rally.
The Blueprint Outlines Five Keys to Progress:
- Creativity in Research and Discovery: We need to better understand the interaction between the TB bacterium and the human immune system; explore new mechanisms for vaccines (beyond protein based antigens); and facilitate pre-clinical research and the development of new models for TB.
- Correlates of Immunity and Biomarkers for TB Vaccines: Next to the identification of safe and effective candidates, no issue is more critical to successful development of new TB vaccines than the discovery of biomarkers: indicators that predict natural protection or susceptibility to disease and that may predict vaccine efficacy and reduce time, cost and the number of participants needed for large-scale clinical trials.
- Clinical Trials – Harmonization and Cooperation: Clinical testing of new TB vaccines is expensive and complicated on both a scientific and a logistical level and presents major hurdles as candidates advance toward Phase III trials for potential licensure. To overcome these challenges, we must determine TB prevalence and incidence, prioritize trial site selection, better define clinical endpoints and engage regulatory authorities early in the process to address regulatory, ethical and sustainability issues.
- Rational Selection of TB Vaccine Candidates: The field needs to establish global criteria for vaccine candidate assessment to determine which candidates to move forward from the lab to late stage clinical trials.
- Building Support through Advocacy, Communications and Resource Mobilization: We must effectively engage key stakeholders in the media, government, NGO and affected communities to generate political will and investment in TB vaccine development.
The Blueprint appears in a special edition of the journal Tuberculosis and was produced under the auspices of the Stop TB Partnership’s Working Group on New Vaccines. Co-edited by Dr. Michael Brennan and Dr. Jelle Thole of Aeras and the Tuberculosis Vaccine Initiative (TBVI) respectively – which are two of the leading TB vaccine research and development organizations globally – the Blueprint is a bold and pragmatic scientific plan that highlights how researchers and advocates can create stronger partnerships to work together to develop a fully effective TB vaccine.
TB remains grossly overlooked by global decision makers whose support we need to help drive greater action. According to a report by the Treatment Action Group, the $78 million TB vaccine investment for 2010 was $302 million short of the $380 million the Stop TB Partnership indicated as needed in their Global Plan to Stop TB. We need more doctors, vaccine researchers, and people living with or affected by TB to raise awareness about the impact of the disease and to demand support for new tools.
When we think about the desperate need for a TB vaccine, we need to stay focused on people – the babies, children, women and men who are vulnerable to getting sick from and dying of TB. Without a new vaccine, TB will continue to wreak havoc on the lives of millions. It is high time we answered the scientific questions that remain roadblocks to developing new TB vaccines.
I encourage advocates to use Tuberculosis Vaccines: A Strategic Blueprint for the Next Decade as a resource to show global leaders that we can, and will, bring new vaccines to fruition if this effort is prioritized. Researchers and advocates need to coordinate their efforts. This is the only way we will realize the vision in the Blueprint.
Over the past decade, tremendous progress has been made toward developing better TB vaccines. We went from having zero new vaccine candidates to 12 vaccine candidates in clinical trials globally. With the Blueprint, we will be able to make even more progress in the decade to come. A global meeting of TB vaccine researchers and advocates – the Third Global Forum on TB Vaccines – is scheduled for March 24, 2013 in Cape Town, South Africa. This World TB Day, let’s resolve to make that conference the deadline for each of us to begin to play our part in increasing local, national and global support for TB vaccine development.