Vaccines

Abstract

The course on Vaccines covers different steps in the development of vaccines from the selection of target infection through to post-approval surveillance. Specific aspects in production of viral and bacterial antigens and the final vaccine, in clinical development of the vaccine, the regulatory requirements and pharmacovigilance will be discussed. Aspects of therapeutic vaccines will be discussed

Objective

Students acquire the ability to anticipate problems, analyse complex situations, and offer a strategy for the development of vaccines. Students understand the complexity of vaccine development and production. Students can define interaction with different partners involved in the development/production af a vaccine and with the competent authority during the approval procedure. Students understand possibility of vaccines against medical diseases.

Content

Production of antigen and final vaccine: - Bacterial and viral antigens: Isolation, purification, research&development production - Modification of antigen: Toxin to toxoid, polysaccharide-protein complex (conjugation - Formulation and stability - Manufacturing of final vaccine - Requirements regarding manufacturing suites, gowning, hygiene, etc. Clinical development: - Selection of antigens - Adjuvant vs. no adjuvant - Specific problems in studies for prophylactic vaccines - Occurrence of infection in targeted population and geographic region - Criteria for the Phase 1 through 4 studies - Surrogate marker or clinical endpoint - Guidelines for selected vaccines - Vaccines for pandemic diseases Regulatory specifics: - Differences between pharmaceuticals and biologicals - The manufacturing process in biologicals - Batch release - Variations /Changes - Stability testing / VVMs Pharmacovigilance: - Pharmacovigilance in clinical trials - Post-approval safety surveillance Therapeutic vaccines for medical diseases: - Prophylactic vs. Therapeutic Vaccines - Immunological Background - Virus Like Particles: Nature's Nanoparticles - Preclinical Testing / Toxicology - Clinical Strategies - Clinical Examples

Resources