Ana Ascaso-del-Rio, Javier García-Pérez, Mayte Pérez-Olmeda, Eunate Arana-Arri, Itziar Vergara, Carla Pérez-Ingidua, Mercedes Bermejo, María Castillo de la Osa, Natale Imaz-Ayo, Ioana Riaño Fernández, Oliver Astasio González, Francisco Díez-Fuertes, Susana Meijide, Julio Arrizabalaga, Lourdes Hernández Gutiérrez, Humberto Erick de la Torre-Tarazona, Alberto Mariano Lázaro, Emilio Vargas-Castrillón, José Alcamí, and Antonio Portolés
Summary: Background: There is no evidence to date on immunogenic response among individuals who participated in clinical trials of COVID-19 experimental vaccines redirected to standard national vaccination regimens. Methods: This multicentre, prospective controlled cohort study included subjects who received a COVID-19 experimental vaccine (CVnCoV)(test group, TG) - and unvaccinated subjects (control group, CG), selected among individuals to be vaccinated according to the Spanish vaccination program. All study subjects received BNT162b2 as a standard national vaccination schedule, except 8 (from CG) who received mRNA-1273 and were excluded from immunogenicity analyses. Anti-RBD antibodies level and neutralising titres (NT50) against G614, Beta, Mu, Delta and Omicron variants were analysed. Reactogenicity was also assessed. Findings: 130 participants (TG:92; CG:38) completed standard vaccination. In TG, median (IQR) of anti-RBD antibodies after first BNT162b2 dose were 10740·0 BAU/mL (4466·0-12500) compared to 29·8 BAU/mL (14·5-47·8) in CG (p