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

https://www.medrxiv.org/content/10.1101/2021.02.22.21252091v1

Arturo Chang-Monteagudo, Rolando Ochoa-Azze, Yanet Climent-Ruiz, Consuelo Macías-Abraham,
Laura Rodríguez-Noda, Carmen Valenzuela-Silva, Belinda Sánchez-Ramírez, Rocmira Perez-Nicado, Raúl González-Mugica, Tays Hernández-García, Ivette Orosa-Vázquez, Marianniz Díaz-Hernández, María de los A. García-García, Yanet Jerez-Barceló, Yenisey Triana-Marrero, Laura Ruiz-Villegas, Luis Rodríguez-Prieto, Rinaldo Puga-Gómez, Pedro Pablo Guerra-Chaviano, Yaíma Zúñiga-Rosales, Beatriz Marcheco-Teruel, Mireida
Rodríguez-Acosta,7 Enrique Noa-Romero,7 Juliet Enríquez-Puertas, Delia Porto-González, Kalet
Leon-Monzon, Guan-Wu Chen, Luis Herrera Martinez, Yury Valdés-Balbín, Dagmar García-Rivera, Vicente Vérez-Bencomo1 and The Soberana 01B Clinical Trial team

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Resumen	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.
Procedencia del autor	Cuba

Resumen

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.

Procedencia del autor

Cuba

Texto completo	2021.02.22.21252091v1.full.pdf

Tipo de documento	Vacunas

Publicado en el sitio	2021-11-23 19:08:51

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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

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