Immunogenicity of Third mRNA-based Vaccination Dose in Elderly
Work package objectives:
The key objective for WP11, together with WP12, is the set-up of the master protocol trial platform “A multinational Phase 2, Randomised, Evaluator-Blinded, Adaptive Master Protocol to Evaluate the Impact of Different COVID-19 Vaccine Booster Strategies in Adults Already Vaccinated Against SARS-CoV-2” and the conduct of two respective subtrials run on the platform. The overarching primary objective is the evaluation of the immune response against wild-type SARS-CoV-2 following different third dose mRNA-based COVID-19 vaccine booster strategies in the adult population. As overarching secondary objectives, safety of third doses of COVID-19 vaccines as well as the humoral immune response against SARS-CoV-2 variants of concern (VOCs).
The two trials are anticipated to be conducted at up to 24 clinical trial sites in up to eight European countries. All samples will be analysed in selected central lab(s) in Europe.
Prof. Oliver A. Cornely, MD
CECAD Cluster of Excellence University of Cologne, Center for Clinical Trials
University Hospital Dep. I for Internal Medicine, Division of Infectious Diseases
University Hospital, Cologne, Germany