Challenge trials serve as a valuable means to thoroughly document the effectiveness of vaccines in combating specific pathogen infections. These trials involve comparing the efficacy of the vaccine with a negative control group (unvaccinated) and a positive control group (using a competitor vaccine), allowing for a comprehensive assessment of the vaccine's performance in preventing transmission and reducing the severity of the infection.
Duration of Protection (DOP) can be effectively documented through challenge trials conducted at specific intervals following vaccination, typically spanning durations of 6, 12, or 18 months. DOP trials can also be conducted on a larger scale in real-world field conditions to further validate the vaccine's performance and effectiveness.
Studies aimed at documenting the safety of vaccines involve a comprehensive evaluation of potential adverse events following vaccination. These trials can be performed according to the principles of Good Laboratory Practice (GLP).
Vaccine batches can be distributed following meticulous evaluation and quality control of efficacy and safety in fish, carried out in adherence to the principles of Good Manufacturing Practice (GMP).
Research Director, PhD