Adjuvants have the potential to improve current vaccines, and to make possible new vaccines. Dynavax technologies is considering the potential uses of adjuvant and working on designing a program to efficiently evaluate the relevant hypothesis tests, by working with expert agencies to identify most efficient path forward to registration. Focus is kept on clinical safety endpoints, but consideration is given to the efficient use of laboratory assessments. Effective development programs are needed to realize the potential of adjuvants for patients who suffer from vaccine preventable diseases.
In this presentation, Dr.Tyler Martin gives details about the Clinical Development of MF59.
Rationale: To develop a defined adjuvant
Â· Oil-in-water emulsion
Â· Mechanism not understood
Â· Flu vaccine put on clinical hold in US after unexpected toxicity in phase 1 clinical trial
Â· MTP-PE removed from FLU formulation, development restarted in Europe
Â· HIV vaccine hit funding roadblock
Â· HSV vaccine missed phase 3 primary endpoint
Â· Flu program demonstrated positive results in Europe, leading to resumption of the development in US
Â· FLUAD (Influenza/MF59) approved in Europe, not yet approved in the US.
If you are interested, then please download the full presentation to discover more about navigating the clinical trial landscape for vaccines with novel adjuvants:
Â· Considerations for the overall clinical development program for vaccines with novel adjuvants
Â· Managing needs across international borders, different agencies with different philosophies on adjuvants
Â· Balancing screening, laboratory monitoring and clinical monitoring in safety evaluations
Â· Benefits of adjuvants: outcomes of the recent Phase 3 trials on a hepatitis B vaccine with a novel adjuvant
Dr Tyler Martin, Chief Medical Officer, Dynavax