scholarly journals 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

2021 ◽  
Author(s):  
Arturo Chang-Monteagudo ◽  
Rolando Ochoa-Azze ◽  
Yanet Climent-Ruiz ◽  
Consuelo Macías-Abraham ◽  
Laura Rodríguez-Noda ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Single Dose ◽  
Safety Profile ◽  
Phase 1 ◽  
Fold Increase ◽  
Short Report ◽  
Natural Immunity ◽  
Open Label ◽  
Open Label Phase ◽  
Excellent Safety Profile

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.

scholarly journals Single-Dose Pharmacokinetics and Safety of Meropenem-Vaborbactam in Subjects with Chronic Renal Impairment

2018 ◽  
Vol 62 (3) ◽  
Author(s):  
Christopher M. Rubino ◽  
Sujata M. Bhavnani ◽  
Jeffery S. Loutit ◽  
Brooke Lohse ◽  
Michael N. Dudley ◽  
...  
Keyword(s):  
Renal Function ◽  
Single Dose ◽  
Renal Impairment ◽  
Plasma Clearance ◽  
Phase 1 ◽  
Fold Increase ◽  
Pharmacokinetic Parameters ◽  
Open Label ◽  
Single Dose Study ◽  
Chronic Renal Impairment

ABSTRACTVaborbactam is a member of a new class of β-lactamase inhibitors with inhibitory activity against serine carbapenemases (e.g.,Klebsiella pneumoniaecarbapenemase) that has been developed in combination with meropenem. The pharmacokinetics of the combination was evaluated in 41 subjects with chronic renal impairment in a phase 1, open-label, single-dose study. Subjects were assigned to one of five groups based on renal function: normal (creatinine clearance of ≥90 ml/min), mild (estimated glomerular filtration rate [eGFR] of 60 to 89 ml/min/1.73 m2), moderate (eGFR of 30 to <60), or severe (eGFR of <30) impairment plus end-stage renal disease (ESRD) patients on hemodialysis. Subjects received a single intravenous dose of 1 g of meropenem plus 1 g of vaborbactam by 3-h infusion. The ESRD group received two doses (on and off dialysis) separated by a washout. Pharmacokinetic parameters were estimated by standard noncompartmental methods. For both meropenem and vaborbactam, the area under the concentration-time curve was larger and the elimination half-life was longer with decreasing renal function. Meropenem and vaborbactam total plasma clearance (CLt) rates were similar and decreased with decreasing renal function. Slopes of the linear relationship between eGFR and CLt were similar, indicating a similar proportional reduction in CLt with decreasing renal function. Hemodialysis significantly increased drug clearance of meropenem (mean of 2.21-fold increase in CLt,P< 0.001) and vaborbactam (mean of 5.11-fold increase,P= 0.0235) relative to drug administration off dialysis, consistent with dose recovery rates of 38.3% and 52.9% for meropenem and vaborbactam, respectively, in dialysate. Plasma clearance of meropenem and vaborbactam is reduced with renal impairment, requiring dose adjustment. Hemodialysis removes both drugs. (This study has been registered at ClinicalTrials.gov under identifier NCT02020434.)

An open-label phase 1 clinical trial of the anti-α4β7 monoclonal antibody vedolizumab in HIV-infected individuals

2019 ◽  
Vol 11 (509) ◽  
pp. eaax3447 ◽  
Author(s):  
Michael C. Sneller ◽  
Katherine E. Clarridge ◽  
Catherine Seamon ◽  
Victoria Shi ◽  
Marek D. Zorawski ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Monoclonal Antibody ◽  
Hiv Infection ◽  
Phase 1 ◽  
Single Subject ◽  
Lymphoid Tissues ◽  
Plasma Viremia ◽  
Open Label ◽  
Phase 1 Clinical Trial ◽  
Open Label Phase

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.

scholarly journals ACTR-54. OPEN-LABEL PHASE 1 CLINICAL TRIAL TESTING PERSONALIZED AND TARGETED INTERVENTION WITH SKULL REMODELLING SURGERY TO MAXIMIZE LEVELS OF TTFIELDS INTENSITY FOR HIGHER TREATMENT BENEFIT - THE OPTIMAL TTF STUDY

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 ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase 1 ◽  
Targeted Intervention ◽  
Open Label ◽  
Treatment Benefit ◽  
Phase 1 Clinical Trial ◽  
Trial Testing ◽  
Open Label Phase

An open-label phase 1 clinical trial of the allogeneic side population adipose-derived mesenchymal stem cells in SMA type 1 patients

2021 ◽  
Author(s):  
Rashin Mohseni ◽  
Amir Ali Hamidieh ◽  
Alireza Shoae-Hassani ◽  
Masood Ghahvechi-Akbari ◽  
Anahita Majma ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Stem Cells ◽  
Mesenchymal Stem Cells ◽  
Side Population ◽  
Phase 1 ◽  
Open Label ◽  
Phase 1 Clinical Trial ◽  
Open Label Phase
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