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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

Authors :
Vicente Verez-Bencomo
Kalet Leon-Monzon
Yaima Zuniga-Rosales
Yanet Jerez-Barcelo
Yury Valdés-Balbín
Carmen Valenzuela-Silva
Marianniz Diaz-Hernandez
Yanet Climent-Ruiz
Juliet Enriquez-Puertas
Maria de los A. Garcia-Garcia
Delia Porto-Gonzalez
Raul Gonzalez-Mugica
Dagmar García-Rivera
Belinda Sanchez-Ramirez
Rocmira Perez-Nicado
Guang-Wu Chen
Pedro Pablo Guerra-Chaviano
Luis Herrera Martinez
Mireida Rodriguez-Acosta
Arturo Chang-Monteagudo
Tays Hernandez-Garcia
Rolando Ochoa-Azze
Rinaldo Puga-Gomez
Luis Dairon Rodríguez-Prieto
Ivette Orosa-Vazquez
Laura Ruiz-Villegas
Yenisey Triana-Marrero
Enrique Noa-Romero
Beatriz Marcheco-Teruel
Consuelo Macías-Abraham
Laura M. Rodríguez-Noda
Publication Year :
2021
Publisher :
Cold Spring Harbor Laboratory, 2021.

Abstract

We 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.

Details

Database :
OpenAIRE
Accession number :
edsair.doi...........d49b54584eb53e0bda49ce6494529dce
Full Text :
https://doi.org/10.1101/2021.02.22.21252091