A single dose of SARS-CoV-2 FINLAY-FR-1A dimeric-RBD recombinant vaccine enhances neutralization response in COVID-19 convalescents, with excellent safety profile. A preliminary report of an open-label phase 1 clinical trial
Author:
Chang-Monteagudo Arturo, Ochoa-Azze RolandoORCID, Climent-Ruiz Yanet, Macías-Abraham ConsueloORCID, Rodríguez-Noda Laura, Valenzuela-Silva CarmenORCID, Sánchez-Ramírez Belinda, Perez-Nicado Rocmira, González-Mugica Raúl, Hernández-García Tays, Orosa-Vázquez Ivette, Díaz-Hernández Marianniz, de los A. García-García María, Jerez-Barceló Yanet, Triana-Marrero Yenisey, Ruiz-Villegas Laura, Rodríguez-Prieto Luis, Puga-Gómez Rinaldo, Guerra-Chaviano Pedro Pablo, Zúñiga-Rosales Yaíma, Marcheco-Teruel Beatriz, Rodríguez-Acosta Mireida, Noa-Romero Enrique, Enríquez-Puertas Juliet, Porto-González Delia, Leon-Monzon Kalet, Chen Guan-Wu, Martinez Luis Herrera, Valdés-Balbín YuryORCID, García-Rivera DagmarORCID, Vérez-Bencomo VicenteORCID,
Abstract
AbstractWe evaluated response to a single dose of the FINLAY-FR-1A recombinant dimeric-RBD base vaccine during a phase I clinical trial with 30 COVID-19 convalescents, to test its capacity for boosting natural immunity. This short report shows: a) an excellent safety profile one month after vaccination for all participants, similar to that previously found during vaccination of naïve individuals; b) a single dose of vaccine induces a >20 fold increase in antibody response one week after vaccination and remarkably 4-fold higher virus neutralization compared to the median obtained for Cuban convalescent serum panel. These preliminary results prompt initiation of a phase II trial in order to establish a general vaccination protocol for convalescents.
Publisher
Cold Spring Harbor Laboratory
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