Safety and immunogenicity of a synthetic carbohydrate conjugate vaccine against Shigella flexneri 2a in healthy adult volunteers: a phase 1, dose-escalating, single-blind, randomised, placebo-controlled study

2020 ◽  
Author(s):  
Dani Cohen ◽  
Jacob Atsmon ◽  
Cécile Artaud ◽  
Shiri Meron-Sudai ◽  
Marie-Lise Gougeon ◽  
...  
Keyword(s):  
Conjugate Vaccine ◽  
Healthy Adult ◽  
Phase 1 ◽  
Shigella Flexneri ◽  
Controlled Study ◽  
Shigella Flexneri 2A ◽  
Synthetic Carbohydrate ◽  
Adult Volunteers ◽  
Single Blind ◽  
Dose Escalating

scholarly journals A Phase 1 Study of a Recombinant Viruslike Particle Vaccine against Human Papillomavirus Type 11 in Healthy Adult Volunteers

2001 ◽  
Vol 183 (10) ◽  
pp. 1485-1493 ◽  
Author(s):  
Thomas G. Evans ◽  
William Bonnez ◽  
Robert C. Rose ◽  
Scott Koenig ◽  
Lisa Demeter ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
Healthy Adult ◽  
Phase 1 ◽  
Phase 1 Study ◽  
Viruslike Particle ◽  
Adult Volunteers

scholarly journals Antiviral Activity of Oral JNJ-53718678 in Healthy Adult Volunteers Challenged With Respiratory Syncytial Virus: A Placebo-Controlled Study

2018 ◽  
Vol 218 (5) ◽  
pp. 748-756 ◽  
Author(s):  
Marita Stevens ◽  
Sarah Rusch ◽  
John DeVincenzo ◽  
Young-In Kim ◽  
Lisa Harrison ◽  
...  
Keyword(s):  
Respiratory Syncytial Virus ◽  
Antiviral Activity ◽  
Healthy Adult ◽  
Controlled Study ◽  
Syncytial Virus ◽  
Adult Volunteers

scholarly journals Phase 1 Safety and Pharmacokinetic Study of Chimeric Murine-Human Monoclonal Antibody cαStx2 Administered Intravenously to Healthy Adult Volunteers

2005 ◽  
Vol 49 (5) ◽  
pp. 1808-1812 ◽  
Author(s):  
Thomas C. Dowling ◽  
Pierre A. Chavaillaz ◽  
David G. Young ◽  
Angela Melton-Celsa ◽  
Alison O'Brien ◽  
...  
Keyword(s):  
Shiga Toxin ◽  
Healthy Adult ◽  
Phase 1 ◽  
Human Monoclonal Antibody ◽  
Dose Range ◽  
Volume Of Distribution ◽  
Pharmacokinetic Studies ◽  
Human Antibody ◽  
Chimeric Mouse ◽  
Adult Volunteers

ABSTRACT Hemolytic-uremic syndrome (HUS) is a serious complication of infection by Shiga toxin-producing Escherichia coli. Shiga toxin type 2 (Stx2) is responsible for the renal toxicity that can follow intestinal infection and hemorrhagic colitis due to E. coli. A chimeric mouse-human antibody, designated cαStx2, that has neutralizing activity in a mouse model was produced and tested in healthy adult volunteers. In this phase I dose escalation study, cαStx2 was generally well tolerated. Pharmacokinetic studies indicated that clearance was stable over the dose range of 1.0 to 10 mg/kg of body weight (0.249 ± 0.023 ml/kg/h) but was higher for the 0.1-mg/kg dose (0.540 ± 0.078 ml/kg/h), suggesting saturable elimination. A similar nonlinear trend was observed for the volume of distribution, where average values ranged from 0.064 ± 0.015 liter/kg for the 1.0- to 10-mg/kg doses and 0.043 ± 0.005 for the 0.01-mg/kg dose. The relatively small volume of distribution suggests that the antibody is limited to the vascular (plasma) compartment. The mean half-life was 165 ± 66 h, with lowest values observed for the 0.1-mg/kg dose (56.2 ± 9.7 h) and the highest values reported for the 10.0-mg/kg dose (206.4 ± 12.4 h). Future studies are needed to confirm the safety of this cαStx2, and innovative clinical trials will be required to measure its efficacy in preventing or treating HUS.

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