The following post is by Annmarie Leadman, Director of Communications at the Aeras Global TB Vaccine Foundation and Babs Verblackt, Associate Communications at TuBerculosis Vaccine Initiative – TBVI.
Christine Sizemore of the U.S. National Institutes of Health called on the TB vaccine research field to challenge dogma and to think outside the box as scientists and researchers move into the next generation of TB vaccine development. Her sentiments echoed a common theme on the final day of the 2nd Global Forum on TB Vaccines in Tallinn, Estonia as more than 200 participants from 31 countries brought the meeting to a conclusion.
Moving forward toward a common agenda, attendees identified priorities for the next decade, the foundation for a revised Blueprint for TB Vaccines that will be developed over the next year. The Blueprint will serve as a TB vaccine guidance document defining the critical challenges for basic research, product development, manufacturing and clinical development, and will lay the groundwork for rapid uptake and adoption of a new TB vaccine when licensed.
The Forum in Tallinn created a venue to celebrate accomplishments in field that now has 10 TB vaccines currently undergoing clinical trials, a major advancement since 2001 when the first Global Forum on TB Vaccines was convened and not one vaccine had advanced to human testing trials. This year, clinical trials of two vaccines were announced as well as a number of innovative new developments, including an assay development project to improve the assessment of vaccine efficacy.
“The TB incidence rate is going down,” said Christopher Dye of the World Health Organization in Geneva, attributing the success to improved TB case detection and treatment. “But the problem is that it is going down slowly,” and a more effective TB vaccine could have a major impact and shift the emphasis from cure to prevention, he said.
The Forum also provided a venue of examination and reassessment of the challenges in TB vaccine development that range from the scientific complexities of developing vaccines against a disease without predictive animal models and no known correlates of protection, to accurate development timeline projections based on lessons learned, clinical trial design and financial support in an increasingly difficult fundraising environment.
Noting that funding continues to be a constraint, Peter Small, Senior Program Officer for TB at the Bill & Melinda Gates Foundation, said “vaccines are the best buy in public health” and called on government and philanthropy as well as biotech and pharmaceutical companies to do their part.
A number of presenters discussed the need to vastly expand the number of clinical trial research sites in areas of high TB burden and the need to increase staff capacity, infrastructure and community awareness and support for clinical trials. Clinical researchers are also looking at alternative trial design modalities to accelerate clinical trial development timelines.
The preliminary results of a market research study on TB vaccines presented at the meeting found that TB is considered a major public health issue by national level decision makers in high TB burden countries, but that it does not get prioritized as a health care priority. The study commissioned by the Aeras Global TB Vaccine Foundation and to be published next year was undertaken in China, India, South Africa, Brazil, Russia, Mozambique, Cambodia and Romania. Researchers conducted interviews with senior government health and finance officials, parliamentarians, NGO representatives and the media.
To learn more about the 2nd Global Forum on TB Vaccine Development, visit the conference website. Presentations from the meeting will be posted on the conference website by Oct. 5, 2010.