scholarly journals A single dose of SARS-CoV-2 FINLAY-FR-1A vaccine enhances neutralization response in COVID-19 convalescents, with a very good safety profile: An open-label phase 1 clinical trial

2021 ◽  
Vol 4 ◽  
pp. 100079
Author(s):  
Arturo Chang-Monteagudo ◽  
Rolando Ochoa-Azze ◽  
Yanet Climent-Ruiz ◽  
Consuelo Macías-Abraham ◽  
Laura Rodríguez-Noda ◽  
...  
2021 ◽  
Author(s):  
Arturo Chang-Monteagudo ◽  
Rolando Ochoa-Azze ◽  
Yanet Climent-Ruiz ◽  
Consuelo Macías-Abraham ◽  
Laura Rodríguez-Noda ◽  
...  

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.


2019 ◽  
Vol 11 (509) ◽  
pp. eaax3447 ◽  
Author(s):  
Michael C. Sneller ◽  
Katherine E. Clarridge ◽  
Catherine Seamon ◽  
Victoria Shi ◽  
Marek D. Zorawski ◽  
...  

Despite the substantial clinical benefits of antiretroviral therapy (ART), complete eradication of HIV has not been possible. The gastrointestinal tract and associated lymphoid tissues may play an important role in the pathogenesis of HIV infection. The integrin α4β7 facilitates homing of T lymphocytes to the gut by binding to the mucosal addressin cell adhesion molecule-1 (MAdCAM-1) expressed on venules in gut-associated lymphoid tissue. CD4+ T cells with increased expression of α4β7 are susceptible to HIV infection and may be key players in subsequent virus dissemination. Data from nonhuman primate models infected with simian immunodeficiency virus (SIV) have suggested that blockade of the α4β7/MAdCAM-1 interaction may be effective at preventing SIV infection and may have beneficial effects in animals with established viral infection. To explore whether these findings could be reproduced in HIV-infected individuals after interruption of ART, we conducted an open-label phase 1 clinical trial of vedolizumab, a monoclonal antibody against α4β7 integrin. Vedolizumab infusions in 20 HIV-infected individuals were well tolerated with no serious adverse events related to the study drug. After interruption of ART, the median time to meeting protocol criteria to restart therapy was 13 weeks. The median duration of plasma viremia of <400 copies/ml was 5.4 weeks. Only a single subject in the trial experienced prolonged suppression of plasma viremia after interruption of ART. These results suggest that blockade of α4β7 may not be an effective strategy for inducing virological remission in HIV-infected individuals after ART interruption.


2017 ◽  
Vol 19 (suppl_6) ◽  
pp. vi12-vi12
Author(s):  
Anders Rosendal Korshoej ◽  
Frederik Lundgaard Hansen ◽  
Lukacova Slavka ◽  
Søren Ole Stigaard Cortnum ◽  
Yasmin Lassen-Ramshad ◽  
...  

Author(s):  
Rashin Mohseni ◽  
Amir Ali Hamidieh ◽  
Alireza Shoae-Hassani ◽  
Masood Ghahvechi-Akbari ◽  
Anahita Majma ◽  
...  

2020 ◽  
pp. 100689
Author(s):  
Pablo Tebas ◽  
ShuPing Yang ◽  
Jean D. Boyer ◽  
Emma L. Reuschel ◽  
Ami Patel ◽  
...  

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