RT Journal Article
T1 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.
A1 Ascaso del Río, Ana
A1 García Pérez, Javier
A1 Pérez Olmeda, Mayte
A1 Arana Arri, Eunate
A1 Vergara, Itziar
A1 Pérez Ingidua, Carla
A1 Bermejo, Mercedes
A1 Castillo de la Osa, María
A1 Imaz Ayo, Natale
A1 Riaño Fernández, Ioana
A1 Astasio González, Oliver
A1 Díez Fuertes, Francisco
A1 Mejide, Susana
A1 Arrizabalaga, Julio
A1 Hernández Gutiérrez, Lourdes
A1 De la Torre Tarazona, Humberto Erick
A1 Lázaro, Alberto Mariano
A1 Vargas Castrillón, Emilio
A1 Alcamí, José
A1 Portolés Pérez, Antonio
AB 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
PB Elsevier
SN 2589-5370
YR 2022
FD 2022-07-01
LK https://hdl.handle.net/20.500.14352/116012
UL https://hdl.handle.net/20.500.14352/116012
LA eng
NO Ascaso-Del-Rio A, García-Pérez J, Pérez-Olmeda M, Arana-Arri E, Vergara I, Pérez-Ingidua C, Bermejo M, Castillo de la Osa M, Imaz-Ayo N, Riaño Fernández I, et al. 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. EClinicalmedicine, 51 (2022), p. 101542, ISSN 2589-5370. https://doi.org/10.1016/j.eclinm.2022.101542.
NO Instituto de Salud Carlos III
NO COVID-19 Fund
NO Unión Europea
DS Docta Complutense
RD 14 dic 2025