Vaccine Development Process Map

The in vitro study phase of vaccine development seeks to assess the potential of candidate antigens/vaccines to induce an immune response that is likely to be protective without being adversely reactogenic/toxic. It usually involves a basic immunogenicity study in mice, normally through the parental route (s/c or i/m), with a prime boost schedule, taking serum (and/or possibly peripheral blood mononuclear cells (PBMCs) two weeks after boosting and assessing antibody and/or T cell titre and function, while confirming that the animals have not experienced adverse vaccine-related events.

• develop, characterise and quantify the candidate vaccine
• plan animal study with hypothesis power to prove/disprove hypothesis
• run animal study with prime followed by usually a single boost, with daily monitoring of mice for signs of reactogenicity, etc
• bleed out mice at end of study and prepare serum and/or PBMC
• assess serum/PMBC for vaccine-specific antibodies +/- T cell numbers and function
• determine whether vaccine was safe and hypothesis proved/disproved
• used to establish preclinical proof of concept

• candidate vaccine development
• candidate vaccine antigen and technology freedom to operate
• availability of assays to characterise vaccine/antigen
• suitability of mice or other small animal for immunogenicity study with chosen vaccine/antigen
• knowledge of likely immune correlates of protection for chosen vaccine on which to base study
• availability of suitable in vitro functional assays for vaccine (eg serum bactericidal assay, opsonophagocytic assays)

• vaccine development - specific for each vaccine
• Freedom to Operate (FTO) – early engagement of patent/legal team
• vaccine characterisation – availability of a team experienced and knowledgeable in vaccine characterisation and development/adaptation of assays for this
• suitable animal model – from review of scientific literature pertaining to vaccine/disease
• likely correlates of protection (CoP) - from review of scientific literature pertaining to vaccine/disease
• in vitro function assays – team of immunologists capable of developing such assays

• patent/legal team
• team experienced and knowledgeable in vaccine characterisation and development/adaptation of assays
• team of immunologists to develop in vitro functional assays