Day 1 :
Keynote Forum
Helder Fernando BrÃgido Martins
Retired Senior Manager at WHO, Mozambique
Keynote: Bringing to widespread public use latest technologies and innovations in vaccines and immunization: A point of view from a developing country – Mozambique
Time : 10:00-11:00
Biography:
Abstract:
Despite the generalized consensus that most effective technologies are useless if not widely used, between the discovery of the various effective vaccines and their widespread use it has always elapsed a long time. In the past, among others, two main factors have justified this long gap of time: widespread use of vaccines implies a complex managerial and logistic delivery system and the introduction of new vaccines imply costs. Money is not always available, particularly in developing countries. In 1974, the EPI programme approved by WHO and recommended to be implemented all over the world, was a gigantic step forward to create the managerial and logistic system to deliver vaccines. At same time, a new era of vaccine promotion started, to raise conscience of vaccines as one of the most cost/effective measures in Public Health. However, even after the EPI was widely adopted all over the world, there has been always a considerable period, between the discovery of new vaccines and their introduction in EPI national programmes. In recent years, a lot of progress had been made in vaccine research and development and a great number of new vaccines were approved for public use and some are still on the pipeline. However, the time between the approval of a vaccine for public use and its effective widespread use is still much more than the desirable and there still are a lot of underutilized vaccines. To complicate the situation, in the last 10 to 20 years, an unexplainable anti-vaccine lobby has been very active, involving many Medical Doctors, to discourage the general public to use vaccines. On the other side, the paradigm of the original EPI programme was based on vaccines for children and women in the fertile age. This was understandable, because, at the time, the important task was to address priority problems. In the last 20 to 30 years, the conscience of the health professionals has moved to realize that there are also very useful and effective vaccines for teenagers, elderly people and adults that should not remain underutilized. Consequently, the EPI paradigm has changed, to include a much bigger number of vaccines. With well-established EPI Programmes, in almost all countries of the world, the managerial and logistic delivery system problems are solved (or, at least, they are not very constringent any more) and the financial constraints to bring to widespread public use an increasing number of vaccines became the main issue, but not the only one. Therefore, now a day, the great challenge is how to reduce the time gap between the approval of a vaccine for public use and its effective widespread use. In this paper, the author uses his wide technical and managerial skills and experience to present suggestion on how to minimize this problem.
Keynote Forum
Nicholas Jackson
Sanofi Pasteur, Lyon, France
Keynote: RSV prevention for high-risk populations: Different approaches for different age groups
Time : 11:30-12:30
Biography:
Abstract:
Respiratory syncytial virus (RSV) represents an important cause of lower respiratory tract illness in infants and children and can result in long-term impacts on respiratory health. RSV also represents a major viral cause of acute exacerbations in chronic obstructive pulmonary disease in older adults. Based on the Immunobiology of RSV, different approaches are necessary to prevent and reduce the burden of disease caused by RSV in different age groups. This presentation will provide an overview and status of the RSV vaccine field (active and passive approaches), as well as a more detailed view of the Sanofi Pasteur efforts in targeting RSV-vulnerable populations.
Keynote Forum
Stefania Di Marco
ADVENT - IRBM Science Park SpA, Italy
Keynote: Production and characterization of viral vectors for vaccine development
Time : 13:30-14:30
Biography:
Stefania Di Marco is a PhD Biochemist with 18-year research experience in preclinical drug discovery and development, employing molecular biology, biochemistry and X-ray crystallography for functional studies and structure-based drug design in the pharma industry. Eight-year GMP experience in production, testing and release of investigational vaccines for infectious diseases and cancer. She is an author of 54 publications and inventor of four patents (h-index 31; source Google Scholar). Currently, Qualified Person at the GMP facility ADVENT, c/o IRBM Science Park, Pomezia-Roma.
Abstract:
Potent immunogenicity and lack of prolonged transgene expression have made Adenoviruses (Ad) attractive viral vectors for vaccine development. They possess a stable virion, allowing inserts of large foreign genes, they can infect many different cell types and the transferred information remains epichromosomal, thus avoiding the risk of insertional mutagenesis. Preclinical and clinical results conclusively showed superiority of Adenovirus-vectored genetic vaccines, based on the most common human Adenovirus serotype 5 (Ad5), for the induction of T cell response. However, pre-existing immunity to Ad5 has shown to blunt significantly the immunological response induced by Ad5-vectored vaccines in rodents, non-human primates and in humans. Chimpanzee Adenoviruses (ChAd) do not cause pathological illness in humans and antibodies against them have low/no seroprevalence in the human population. Moreover, they have been shown to be very good immunogens in animal models. A large screening of ChAd has been performed and several strains were identified, which were rendered replication incompetent and suitable as vaccine vector candidates. Amongst this collection, several replication defective chimpanzee-derived adenoviruses have been selected for evaluation as clinical products against infectious diseases like Ebola, HCV, RSV, leishmaniosis and malaria. The production and the characterization of the ChAd platform and their development as prophylactic and therapeutic vaccines will be presented.
Keynote Forum
Liwei He
Sanofi Pasteur, Canada
Keynote: Flow cytometry: An efficient method for antigenicity measurement and particle characterization on an adjuvanted vaccine candidate H4-IC31 for Tuberculosis
Time : 10:00-11:00
Biography:
Liwei He has over 25 years of experience in academia and pharmaceutical industry. Currently he is working as a Scientist in the Analytical Research and Development Department at Sanofi Pasteur in Toronto. He has contributed to several vaccine projects and developed analytical test methods for characterization of vaccine products. He has also led several new multiplex based approaches for characterization and quantification of antigens and has contributed to the validation of these methods in accordance with the regulatory guidelines. To date, he has contributed to several scientific publications and co-authored a few patents related to vaccine technologies.
Abstract:
We have developed an accurate, precise and stability-indicating flow cytometry (FC) based assay to directly measure antigenicity of H4 protein in a vaccine formulation of H4-IC31, without desorbing the H4 protein from the IC31 adjuvant. This method involves immuno-staining of H4-IC31 complex with anti-H4 monoclonal antibodies (mAbs) followed by FC analysis. The assay is not only able to consistently measure H4 antigenicity levels in H4-IC31 stored under normal condition at 2-8°C, but also able to detect changes in H4 antigenicity after H4-IC31 undergoes heat stress or freeze-thawing. In addition, the FC method is able to characterize particle morphology while measuring antigenicity. The biological relevance of the changes in H4 antigenicity detected by the FC assay was supported by an in vitro cell based functional assay using human PBMCs to measure IFN-gamma (IFN-γ) secretion upon re-stimulation with H4-IC31. Our results show that the FC based antigenicity assay can efficiently monitor the biological and physicochemical properties of H4-IC31 and is an indicator for adjuvanted vaccine product stability.