World Immunisation Week vaccines NTDs TBVI AerasFor the final article of our coverage of World Immunisation Week and the future of vaccines, Ann M. Ginsberg, MD, PhD, Chief Medical Officer at Aeras – a nonprofit biotechnology organisation developing new, effective tuberculosis (TB) vaccines that are affordable and accessible to all who need them – give us an insight into the opportunities and challenges facing organisations involved in vaccine research. For the other articles in the series, click here!

Can you tell us a little about what kind of organisation Aeras is?

Aeras is a nonprofit, global biotech organization developing new tuberculosis vaccines for the world. With offices in the U.S., Africa, and Asia, Aeras works in partnership with other biotech, pharmaceutical, and academic organizations to advance the best TB vaccine science, with the mission of ending the threat of TB and with the belief that an effective vaccine is key to this mission.

Aeras’s involvement in the vaccine development process spans from the preclinical space to registration and licensure. Bringing together the best science, wherever it may be, Aeras partners to expand and share knowledge and strengthen research and clinical trial capacity for TB vaccine R&D, as we drive to bring together funders from both the public and private sectors. To better understand how TB vaccines work, Aeras is helping to develop new and improved human challenge and animal models of disease and examining correlates of risk and protection. Aeras is designing and conducting new experimental medicine studies to examine key immunological, clinical and vaccinology questions. Aeras’s innovative and adaptive clinical trial designs aim to reduce the cost of TB vaccine development by allowing smaller, faster trials. Aeras is building and managing a diverse portfolio of TB vaccine candidates, collaborating with partners to develop candidates.

What’s in the pipeline for Aeras in the vaccine field?

At the moment, Aeras is a partner in 5 of the 13 clinical vaccine development programs currently underway. Later this year, we expect to generate important primary data from a Phase 2 pre-proof of concept, Prevention of Infection clinical trial of H4:IC31 (040-404 study, a protein/adjuvant candidate, being conducted with our partner, Sanofi Pasteur). We are also conducting a Phase 2b Prevention of Disease trial of another protein/adjuvant candidate, M72+AS01E in partnership with GSK. To further understanding of TB vaccine science, we are collecting blood samples from participants in these trials in an effort to identify correlates of protection and/or disease, which would advance and streamline the entire process of TB vaccine development.

To facilitate sharing of knowledge, Aeras has recently held more than 10 scientific and product development symposia on key aspects of TB vaccine development, some in collaboration with NIAID/NIH and other partners

What is the biggest hurdle for organisations like yours involved in disease research? What is the one thing that could help you in overcoming this (regulatory, political, resources, etc.)?

TB research as a whole suffers from a lack of attention that is disproportionate to the huge burden of disease globally. In the R&D space, unanswered scientific questions, including the specifics of the human protective immune response in TB, and the lack of a validated correlate of protection from TB, make the development process more challenging. Answering these questions requires resources, both human and financial. We need more scientists working in the space, more private sector support, more political will, and more funding.

Resources will allow us to further advance promising candidates, conducting trials that will provide the data that can illuminate the more poorly understood areas of TB science. TB is the leading infectious cause of death due to a single agent, and the field is scientifically exciting and promising, but without more resources, the strides we and others can make in this field with be limited, and much too slow to control the global epidemic.


More information on Aeras is available here: www.aeras.org