2026-04-28T16:32:35Zhttps://repisalud.isciii.es/rest/oai/requestoai:repisalud.isciii.es:20.500.12105/159792024-11-29T08:44:25Zcom_20.500.12105_2052com_20.500.12105_2051com_20.500.12105_15322col_20.500.12105_19609col_20.500.12105_16969col_20.500.12105_16976col_20.500.12105_16974
Repisalud
author
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
funder
Instituto de Salud Carlos III
funder
Centro de Investigación Biomédica en Red - CIBERINFEC (Enfermedades Infecciosas)
funder
Unión Europea. Fondo Europeo de Desarrollo Regional (FEDER/ERDF)
2023-05-05T08:12:29Z
2023-05-05T08:12:29Z
2022-07
EClinicalMedicine. 2022 Jul 1;51:101542.
http://hdl.handle.net/20.500.12105/15979
35795398
10.1016/j.eclinm.2022.101542
2589-5370
EClinicalMedicine
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.
eng
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
research article
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ImmuneResponseReactogenicityImmunization_2022.pdf
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Supplementary_ImmuneResponseReactogenicityImmunization_2022.pdf
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ImmuneResponseReactogenicityImmunization_2022.pdf.txt
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