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00925njm 22002777a 4500 dc Ascaso-Del-Rio, Ana author García-Pérez, Javier author Perez-Olmeda, Mayte author Arana-Arri, Eunate author Vergara, Itziar author Pérez-Ingidua, Carla author Bermejo, Mercedes author Castillo de la Osa, María author Imaz-Ayo, Natale author Riaño Fernández, Ioana author Astasio González, Oliver author Díez-Fuertes, Francisco author Meijide, Susana author Arrizabalaga, Julio author Hernandez, Lourdes author de la Torre-Tarazona, Humberto Erick author Mariano Lázaro, Alberto author Vargas-Castrillón, Emilio author Alcamí, José author Portolés, Antonio author RescueVac study Group author 2022-07 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 <0·0001). Median NT50 (IQR) of G614 was 2674·0 (1865·0-3997·0) in TG and 63·0 (16·0-123·1) in CG (p <0·0001). After second BNT162b2 dose, anti-RBD levels increased to ≥12500 BAU/mL (11625·0-12500) in TG compared to 1859·0 BAU/mL (915·4-3820·0) in CG (p <0·0001). NT50 was 2626·5 (1756·0-5472·0) and 850·4 (525·1-1608·0), respectively (p <0·0001). Variant-specific (Beta, Mu, Omicron) response was also assessed. Most frequent adverse reactions were headache, myalgia, and local pain. No severe AEs were reported. Interpretation: Heterologous BNT162b2 as third and fourth doses in previously suboptimal immunized individuals elicit stronger immune response than that obtained with two doses of BNT162b2. This apparent benefit was also observed in variant-specific response. No safety concerns arose. EClinicalMedicine. 2022 Jul 1;51:101542. http://hdl.handle.net/20.500.12105/15979 35795398 10.1016/j.eclinm.2022.101542 2589-5370 EClinicalMedicine COVID-19 vaccines mRNA vaccines Heterologous vaccination BNT162b2 CVnCoV Fourth dose Neutralizing antibodies Boost doses of vaccines Omicron Experimental vaccines Antibodies Immune Response Immune response and reactogenicity after immunization with two-doses of an experimental COVID-19 vaccine (CVnCOV) followed by a third-fourth shot with a standard mRNA vaccine (BNT162b2): RescueVacs multicenter cohort study