Preclinical studies: an overview
Nancy SULLIVANDownload presentation
Vaccine candidates and their selection for phase 2/3 trials based on phase I immunological data
Sarah GILBERTDownload presentation
Phase II and III trials- how to launch parallel or sequential pathways for experimental use of Ebola candidate vaccines in these phases?
Ana Maria HENAODownload presentation
Mérieux Foundation event
Ebola vaccine: where are we? How to move forward?
January 12 - 13, 2015 - Les Pensieres Center for Global Health, Veyrier-du-Lac (France)
In the face of an unprecedented Ebola outbreak with over 20,000 cases and 8,000 deaths, Fondation Mérieux co-organized this meeting with WHO and Aviesan (French National Alliance for Life Sciences and Health) to confront the challenges faced by Ebola vaccine researchers with those faced by international, governmental and non-governmental organizations working in the field.
No experimental vaccine has ever been on a faster track to clinical evaluation. The exceptional circumstances pose unique challenges. The scientific community must form new partnerships and coordinate its actions to accelerate research and avoid duplication of efforts. The public health community must weigh ethical issues and the principal of precaution against the imperative to get an Ebola vaccine out to the healthcare workers and populations on the front lines as quickly as possible. Beyond funding for research, vaccine manufacturers are confronted with the issue of scaling up production to be ready to rapidly meet demand should their vaccine candidate succeed in clinical trials. Who should support these risks?
The meeting reviewed the status of Ebola vaccine research, including the latest safety and immunogenicity data on the two candidate vaccines in phase I and II clinical trials. As phase III efficacy trials are about to commence, participants identified the challenges faced by vaccine researchers. They looked in particular at the issue of study design, comparing the approach taken in the three countries that are currently affected. In the face of an unprecedented epidemic, vaccine development must be compressed from a typical 5 – 7 years to just 12 – 18 months.
“What if we can’t demonstrate efficacy?” was an important concern voiced by researchers. It was unanimously agreed that it is essential to collect enough clinical data on the vaccine’s efficacy and safety before the epidemic subsides. Participants felt that, due to the urgency and short timeframe, phase II and III clinical trials should be conducted in parallel rather than sequentially. They also commended the regulatory authorities for adapting their approach to the crisis and enabling researchers to advance more quickly with preliminary data based on a risk-benefit assessment.
The group looked at the sociocultural and ethical challenges inherent in vaccine research. Médecins Sans Frontières shared the lessons learned from past Ebola outbreaks and their impact on their current response. Involving the community in outbreak control is a key success factor.
Participating experts agreed that, while the vaccine will not be the “magic bullet” that will resolve the current epidemic, it will be an indispensable tool to limit the spread of future outbreaks.
Monday 12 January
Tuesday 13 January
SESSION I Ebola vaccine research agenda: A status
Cathy ROTH & Claire-Anne SIEGRIST
SESSION II Challenges in Ebola vaccine research
Marie-Paule KIENY & Ab OSTERHAUS
Challenges inherent to the research design: What to learn from deep immunological monitoring in phase I/II vaccine trials?
Rodolphe THIEBAUTDownload presentation
Challenges related to ethical and regulatory pathways in emergency situations
David WOODDownload presentation
GLOPID: Global Research Collaboration for Infectious Disease Preparedness
Bernadette MURGUEDownload presentation
SESSION III Cultural and programmatic challenges in the implementation of Ebola vaccine programs
Bernadette MURGUE & Marc BONNEVILLE
The evaluation of business models needed for an innovative Ebola vaccine financing system
Robert NEWMANDownload presentation
Benefit-risk considerations for new Ebola vaccines used in emergency situation
Anton CAMACHODownload presentation
MSF perspective: next steps in the development and access for potential new vaccines for Ebola
Manica BALASEGARAMDownload presentation
Socio-cultural and anthropological aspects to account for in vaccine adoption and introduction
Janice GRAHAMDownload presentation
Cindy GRASSO - Conference Coordinator