Learning Outcomes
1. Understand the principles governing preclinical research and development studies of new drugs and vaccines.
2. Understand the principles governing Phase I, II, and III clinical trials of research and development of new drugs and vaccines.
3. Understand the principles governing comparative clinical trials.
4. Understand the regulatory framework for the evaluation of drugs and vaccines.
5. Understand the basic principles of Observational and Intervention studies.
6. Gain deeper understanding of vaccine development studies against SARS-CoV-2.
Course Content (Syllabus)
- Drug Research and Development - Preclinical Studies
- Drug Research and Development - Clinical Phase
- Observational and Interventional Studies, Phase I Studies
- Phase II, III, IV Studies - post-marketing Studies
- Regulatory Framework for Drug and Vaccine Evaluation
- Clinical Trials of Vaccines against SARS-CoV-2
Course Bibliography (Eudoxus)
• COVID-19 vaccines adverse events: potential molecular mechanisms.Lamprinou M, …Papazisis G. Immunol Res. 2023
• Predicting the next pandemic: VACCELERATE ranking of the WorldHealth Organization's Blueprint forAction toPreventEpidemics.Salmanton-García J, et al. VACCELERATE Consortium. Travel Med Infect Dis. 2023 Dec 6;57:102676.
• Serum Proteome Signatures of Anti-SARS-CoV-2 Vaccinated Healthcare Workers in Greece Associated with Their Prior Infection Status.Stamoula E, Sarantidi E, Dimakopoulos V, Ainatzoglou A, Dardalas I, Papazisis G, Kontopoulou K, Anagnostopoulos AK. Int J Mol Sci. 2022 Sep 5;23(17):10153. doi:
• Antibody titers after a third dose of the SARS-CoV-2 BNT162b2 vaccine in immunocompromised adults in Greece: Is a fourth dose necessary? Kontopoulou K, Nakas CT, Belai C, Papazisis G. J Med Virol. 2022
• Second dose of the BNT162b2 mRNA vaccine: Value of timely administration but questionable necessity among the seropositive. Kontopoulou K,…Papazisis G. Vaccine. 2021 Aug 23;39(36):5078-5081.
• Immunogenicity after the first dose of the BNT162b2 mRNA Covid-19 vaccine: real-world evidence from Greek healthcare workers.Kontopoulou K,…Papazisis G. J Med Microbiol. 2021 Aug;70(8):001387. doi:
• Immunogenicity of the BNT162b2 mRNA Covid-19 vaccine in elderly people over 85 years of age in Greece: the GREVAXIMO study.Kontopoulou K, …Papazisis G. Aging Clin Exp Res. 2021 Dec;33(12):3385-3389.