Cuba. Vacuna para todos. Pre-print de EC Fase # 1. Soberana. Una quinta vacuna

 

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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, View ORCID Profile

Rolando Ochoa-Azze, Yanet Climent-Ruiz, View ORCID Profile

Consuelo Macias-Abraham, Laura Rodriguez-Noda, View ORCID Profile

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, View ORCID Profile

Yury Valdes-Balbin, View ORCID Profile

Dagmar Garcia-Rivera, View ORCID Profile

Vicente Verez-Bencomo

doi: https://doi.org/10.1101/2021.02.22.21252091

This article is a preprint and has not been certified by peer review [what does this mean?]. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice.

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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.

Competing Interest Statement

Finlay Vaccine Institute and Center for Molecular Immunology has filed patent applications relating to use vaccination in individuals with preexisting immunity SARS-CoV-2

Clinical Trial

IFV/COR/07 RPCE00000349

Clinical Protocols

https://rpcec.sld.cu/trials/RPCEC00000349

Funding Statement

This work was partially funded by Fondo de Ciencia e Innovacion (FONCI) from the Ministry of Science and Enviroment of Cuba (Project-2020-20)

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Independent Ethical Committee for the Study of Human Subjects in the Institute of Hematology and Immunology

All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Paper in collection COVID-19 SARS-CoV-2 preprints from medRxiv and bioRxiv

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The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission.

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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 https://t.co/5d0B5gDtjY #medRxi

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