Oxford-Emergent Tuberculosis Consortium's Adam Stoten discusses goal of new TB vaccines
Stoten works with Jacqui Shea, the general manager of OETC, to manage the day-to-day activities of the organization, including the corporate governances, relationship management with stakeholders in MVA85A development, management of the organization's finances, and fundraising and oversight for project planning, Human Vaccines reports.
The OETC is a joint venture between the University of Oxford and Emergent BioSolutions, Inc., to develop the MVA85A vaccine, which boosts the only available TB vaccine, Bacille Calmette Guerin.
"(MVA85A) was created by Oxford researchers Dr. Helen McShane, Prof. Adrian Hill and colleagues in 2000," Stoten said, according to Human Vaccines. "Having progressed successfully through early stage clinical trials in the UK and in Africa, by 2006/7 it was clear that the vaccine required a commercial partner to support later stage trials and the development of a robust manufacturing process suitable for global supply."
Stoten said that the development of a new TB vaccine has been difficult because low profit margins in parts of the world where the disease is prevalent have held little appeal for pharmaceutical companies. Significant public funding has helped, but the high price of late-stage vaccine development has continued to be a hurdle. OETC's purpose is to develop and commercialize the MVA85A TB vaccine for developing and developed world markets. The organization has made significant progress for its efforts.
"In terms of OETC, the commencement of the Phase IIb trial of MVA85A in South African infants was a landmark event in that it was the first such trial to be undertaken with any of the next generation TB vaccines, and heralds a genuine new hope for the millions afflicted by the disease," Stoten said, according to Human Vaccines. "The completion of recruitment for this trial in April 2011 was an important step towards obtaining final results, which are expected in 2012."
Stoten said that the challenges for OETC and other companies developing TB vaccines will be designing Phase III trials and securing the funding to support them. The industry is starting to consider if alternative pathways may be possible to licensure which will reduce the cost and time to market. In addition, Stoten said that the company has some goals in the immediate future.
"OETC has some clear near term goals," Stoten said, according to Human Vaccines. "First, to commence the Phase IIb trial in HIV positive adults scheduled to start in summer 2011 at sites in South Africa and Senegal. Second, in 2012 OETC will obtain results from the infant Phase IIb study which we hope will support the further development and licensure of the vaccine in this population. The trial is designed to show a 60% improvement over BCG in terms of protecting against disease."
The current and sole area OETC focuses on is TB vaccine development, including the development of the vaccine for different populations that require a better immunization including infants, HIV positive adults, and HIV negative adolescents and young adults.