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A single dose of SARS CoV 2 FINLAY FR 1A dimeric RBD recombinant vaccine enhances neutralization response in COVID19 convalescents, with excellent safety profile. A preliminary report of an open-label phase 1 clinical trial
Arturo Chang-Monteagudo; Rolando Ochoa-Azze; Yanet Climent-Ruiz; Consuelo Macias-Abraham; Laura Rodriguez-Noda; Carmen Valenzuela-Silva; Belinda Sanchez-Ramirez; Rocmira Perez-Nicado; Raul Gonzalez-Mugica; Tays Hernandez-Garcia; Ivette Orosa-Vazquez; Marianniz Diaz-Hernandez; Maria de los A. Garcia-Garcia; Yanet Jerez-Barcelo; Yenisey Triana-Marrero; Laura Ruiz-Villegas; Luis Rodriguez-Prieto; Rinaldo Puga-Gomez; Pedro Pablo Guerra-Chaviano; Yaima Zuniga-Rosales; Beatriz Marcheco-Teruel; Mireida Rodriguez-Acosta; Enrique Noa-Romero; Juliet Enriquez-Puertas; Delia Porto-Gonzalez; Kalet Leon-Monzon; Guang-Wu Chen; Luis Herrera Martinez; Yury Valdes-Balbin; Dagmar Garcia-Rivera; Vicente Verez-Bencomo.
Afiliación
  • Arturo Chang-Monteagudo; Institute of Hematology and Immunology, Havana, Cuba
  • Rolando Ochoa-Azze; Finlay Vaccine Institute, 200 and 21 Street, Havana 11600, Cuba.
  • Yanet Climent-Ruiz; Finlay Vaccine Institute, 200 and 21 Street, Havana 11600, Cuba
  • Consuelo Macias-Abraham; Institute of Hematology and Immunology, Havana, Cuba
  • Laura Rodriguez-Noda; Finlay Vaccine Institute, 200 and 21 Street, Havana 11600, Cuba
  • Carmen Valenzuela-Silva; Center of Molecular Immunology, P.O. Box 16040, 216 St. Havana, Cuba
  • Belinda Sanchez-Ramirez; Center of Molecular Immunology, P.O. Box 16040, 216 St. Havana, Cuba
  • Rocmira Perez-Nicado; Finlay Vaccine Institute, 200 and 21 Street, Havana 11600, Cuba
  • Raul Gonzalez-Mugica; Finlay Vaccine Institute, 200 and 21 Street, Havana 11600, Cuba
  • Tays Hernandez-Garcia; Center of Molecular Immunology, P.O. Box 16040, 216 St. Havana, Cuba
  • Ivette Orosa-Vazquez; Center of Molecular Immunology, P.O. Box 16040, 216 St. Havana, Cuba
  • Marianniz Diaz-Hernandez; Center of Molecular Immunology, P.O. Box 16040, 216 St. Havana, Cuba
  • Maria de los A. Garcia-Garcia; Finlay Vaccine Institute, 200 and 21 Street, Havana 11600, Cuba
  • Yanet Jerez-Barcelo; Institute of Hematology and Immunology, Havana, Cuba
  • Yenisey Triana-Marrero; Institute of Hematology and Immunology, Havana, Cuba
  • Laura Ruiz-Villegas; Institute of Hematology and Immunology, Havana, Cuba
  • Luis Rodriguez-Prieto; Institute of Hematology and Immunology, Havana, Cuba
  • Rinaldo Puga-Gomez; Cira Garcia Clinic, Calle 20 NO. 4101 esq. a Av. 41 Miramar, La Habana
  • Pedro Pablo Guerra-Chaviano; National Center for Coordination of Clinical Trial (CENCEC) Calle 5ta A e/ 60 y 62 Miramar, Playa, CP 11300, La Habana, Cuba
  • Yaima Zuniga-Rosales; National Center of Medical Genetics, Ave. 31 Esq.146 No 3102, Reparto Cubanacan CP. 11400
  • Beatriz Marcheco-Teruel; National Center of Medical Genetics, Ave. 31 Esq.146 No 3102, Reparto Cubanacan CP. 11400
  • Mireida Rodriguez-Acosta; National Civil Defense Research Laboratory, Cuba
  • Enrique Noa-Romero; National Civil Defense Research Laboratory, Cuba
  • Juliet Enriquez-Puertas; National Civil Defense Research Laboratory, Cuba
  • Delia Porto-Gonzalez; National Blood Program, Ministry of Health, Cuba
  • Kalet Leon-Monzon; Center of Molecular Immunology, P.O. Box 16040, 216 St. Havana, Cuba
  • Guang-Wu Chen; Chengdu Olisynn Biotech. Co. Ltd., and State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, Sichuan University, Chengdu 610041, Peoples Re
  • Luis Herrera Martinez; Biocubafarma, Ave. Independencia #8126, esq. a Calle 100. Boyeros. La Habana. Cuba
  • Yury Valdes-Balbin; Finlay Vaccine Institute, 200 and 21 Street, Havana 11600, Cuba
  • Dagmar Garcia-Rivera; Finlay Vaccine Institute, 200 and 21 Street, Havana 11600, Cuba
  • Vicente Verez-Bencomo; Finlay Vaccine Institute, 200 and 21 Street, Havana 11600, Cuba.
Preprint en En | PREPRINT-MEDRXIV | ID: ppmedrxiv-21252091
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 naive 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.
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Texto completo: 1 Colección: 09-preprints Base de datos: PREPRINT-MEDRXIV Tipo de estudio: Experimental_studies / Prognostic_studies / Rct Idioma: En Año: 2021 Tipo del documento: Preprint
Texto completo
Añadir a Mi BVS
Imprimir
XML
Buscar en Google
Texto completo: 1 Colección: 09-preprints Base de datos: PREPRINT-MEDRXIV Tipo de estudio: Experimental_studies / Prognostic_studies / Rct Idioma: En Año: 2021 Tipo del documento: Preprint