Scale-Up and production of a Bordetella pertussis Bifunctional Vaccine/Adjuvant Candidate for Clinical Trials

Summary 

Our research team has dedicated significant efforts to developing a vaccine prototype against Bordetella infections, particularly Bordetella pertussis, a causative agent of respiratory disease in humans. This prototype based on the outer membrane vesicles (OMVs) derived from the pathogen, has demonstrated promising safety and efficacy in preclinical trials (1–7). We have established a robust platform for obtaining and studying OMVs in the laboratory, identifying them not only as potent immunogens but also as effective adjuvants (8–11).

In this application, our focus is on overcoming a significant challenge in vaccine development: the transition from laboratory testing to clinical trials in humans. This critical step involves producing vaccine candidates at pilot scale under stringent Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) conditions. We also propose designing protocols for clinical trials in humans and field tests for use in other animals.