Reference:
Singh, K., & Mehta, S. (2016). The clinical development process for a novel preventive vaccine: An overview. Journal of Postgraduate Medicine, 62(1), 4–11. https://doi.org/10.4103/0022-3859.173187
Summary:
The article provides a comprehensive overview of the clinical development process for novel preventive vaccines, detailing the essential phases of vaccine trials: Phase I, II, and III. It highlights the importance of evaluating the safety, immunogenicity, and efficacy of vaccine candidates before they can be licensed for use. The manuscript discusses the specific objectives, designs, populations, and outcomes for each trial phase, citing examples from malaria, rotavirus, and HPV vaccine developments. Phase I focuses on safety and optimal dosing in small groups, Phase II assesses immunogenicity and safety in larger populations, and Phase III evaluates efficacy in real-world settings. It notes the unique challenges faced in vaccine development, especially when trials involve healthy individuals, and contrasts these with drug trials. The article emphasises adherence to regulatory guidelines from entities like WHO and EMA, offering a valuable resource for researchers and developers in the field of vaccine development.