Non-clinical safety studies of vaccines

Our experience tells us that the design of non-clinical safety studies for vaccines can look relatively different from case to case and that it is a good idea to think carefully consider a number of important aspects when planning for a GLP tox study for vaccines. Some of the reasons that can cause variations in the study design include:

• That there is a large variation among vaccine structures and mood of action, e.g. inactivated/weakened viral and bacterial preparations, plasmid DNA, nanoparticles and viral vector immunotherapies, as well as vaccines with adjuvant.
• In addition to providing the prerequisite safety data, the selected animal model must also be able to exhibit the desired the therapeutic response needed to achieve the desired immunity. This being said, depending on the indication, it may be sufficient to conduct only the regulatory vaccine toxicity studies solely in one animal species.
• The type of immune response to be measured and how this should be tested and evaluated.

An additional factor to consider lies in that vaccine often possess an innate capacity to induce tolerance for potential risks or side effects, as they often target a healthy population.

We at RISE can help with the strategic choices you need to make in moving your project from he non-clinical to the clinical phase and provide you a tailor-made strategy and study designs that suits your vaccine candidate's unique needs. Always in harmony with relevant regulatory guidelines (for example WHO 2005 and 2013 guidelines).

Our way of working is always adapted to the customer's needs. We offer:

• Conversations with our preclinical toxicologists, immunologists and investigators. We maintain good contact with our partners throughout the assignment to facilitate anchoring of experimental approaches, understanding of experimental results and mature discussions on decisions to made moving forward. RISE's flexible working methods result in both cost and time savings for our partner.
• Analytical characterization of vaccine, protein and biological products. We are able to provide an analytical evaluation of all components of the vaccine, focussing on aspects such as purity, stability and sterility. Many analyses can be developed and/or performed at RISE with the help of our experienced researchers and our broad and advanced instrument park.
• A comprehensive solution for conducting regulatory and other general toxicology studies in mice and rats. We offer non-GLP and GLP compliant studies in rodents in RISE's modern premises, with all necessary components (bioanalysis, clinical chemistry and histopathology) performed in house.
• Study monitoring. Vaccine safety assessments can be both comprehensive and specific and may need to be performed by a variety of contract labs (CROs). RISE toxicologists can monitor (study monitor) studies located at other selected CRO and ensure a consistently good quality in the study, review the trial plan and report. Our toxicologists may aso partake in interpretation of these results and in the development of the overall safety assessment outcome.
• Support prior to the IND application for clinical studies. RISE has experienced staff who have taken over 50 candidates from pre-clinic to clinical trials in humans. We can support you in both regulatory documentation and contact with pharmaceutical authorities.

In summary, with RISE as a partner, you get a well-thought-through toxicological evaluation to take your vaccine candidate as quickly and cost-effectively as possible to clinical studies. When approaching your project we are also able to act flexibly and swiftly in order to meet timelines and reduce the need for complex project management on your side.