Safety and immunogenicity of a novel human Enterovirus 71 (EV71) vaccine: A randomized, placebo-controlled, double-blind, Phase I clinical trial

Vaccine ◽  
2012 ◽  
Vol 30 (22) ◽  
pp. 3295-3303 ◽  
Author(s):  
Yan-Ping Li ◽  
Zheng-Lun Liang ◽  
Qiang Gao ◽  
Li-Rong Huang ◽  
Qun-Ying Mao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase I ◽  
Enterovirus 71 ◽  
Phase I Clinical Trial ◽  
Human Enterovirus ◽  
Double Blind ◽  
Human Enterovirus 71

A randomized, double-blind, phase I clinical trial of fetal cell-based skin substitutes on healing of donor sites in burn patients

Burns ◽  
2019 ◽  
Vol 45 (4) ◽  
pp. 914-922 ◽  
Author(s):  
Mahnoush Momeni ◽  
Nasrin Fallah ◽  
Amir Bajouri ◽  
Tooran Bagheri ◽  
Zahra Orouji ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase I ◽  
Phase I Clinical Trial ◽  
Burn Patients ◽  
Fetal Cell ◽  
Skin Substitutes ◽  
Double Blind

scholarly journals A Double-Blind Randomized Phase I Clinical Trial Targeting ALVAC-HIV Vaccine to Human Dendritic Cells

PLoS ONE ◽  
2011 ◽  
Vol 6 (9) ◽  
pp. e24254 ◽  
Author(s):  
Michael A. Eller ◽  
Bonnie M. Slike ◽  
Josephine H. Cox ◽  
Emil Lesho ◽  
Zhining Wang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Dendritic Cells ◽  
Phase I ◽  
Hiv Vaccine ◽  
Phase I Clinical Trial ◽  
Double Blind ◽  
Human Dendritic Cells

scholarly journals A conditionally replication-defective cytomegalovirus vaccine elicits potent and diverse functional monoclonal antibodies in a phase I clinical trial

npj Vaccines ◽  
2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Leike Li ◽  
Daniel C. Freed ◽  
Yaping Liu ◽  
Fengsheng Li ◽  
Diane F. Barrett ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Monoclonal Antibodies ◽  
Phase I ◽  
Neutralizing Antibodies ◽  
Phase I Clinical Trial ◽  
Double Blind ◽  
Tegument Proteins ◽  
Multiple Components ◽  
Germline Genes ◽  
Cytomegalovirus Vaccine

AbstractA conditionally replication-defective human cytomegalovirus (HCMV) vaccine, V160, was shown to be safe and immunogenic in a two-part, double-blind, randomized, placebo-controlled phase I clinical trial (NCT01986010). However, the specificities and functional properties of V160-elicited antibodies remain undefined. Here, we characterized 272 monoclonal antibodies (mAbs) isolated from single memory B cells of six V160-vaccinated subjects. The mAbs bind to diverse HCMV antigens, including multiple components of the pentamer, gB, and tegument proteins. The most-potent neutralizing antibodies target the pentamer-UL subunits. The binding sites of the antibodies overlap with those of antibodies responding to natural HCMV infection. The majority of the neutralizing antibodies target the gHgL subunit. The non-neutralizing antibodies predominantly target the gB and pp65 proteins. Sequence analysis indicated that V160 induced a class of gHgL antibodies expressing the HV1-18/KV1-5 germline genes in multiple subjects. This study provides valuable insights into primary targets for anti-HCMV antibodies induced by V160 vaccination.

Double-blind, randomized, placebo-controlled Phase I Clinical Trial of the therapeutical antituberculous vaccine RUTI®

Vaccine ◽  
2010 ◽  
Vol 28 (4) ◽  
pp. 1106-1116 ◽  
Author(s):  
C. Vilaplana ◽  
E. Montané ◽  
S. Pinto ◽  
A.M. Barriocanal ◽  
G. Domenech ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase I ◽  
Phase I Clinical Trial ◽  
Double Blind

scholarly journals Safety Evaluation of Topical Application of Nano-Liposomal Form of Amphotericin B (SinaAmpholeish) on Healthy Volunteers; Phase I Clinical Trial

2019 ◽  
Author(s):  
Seyed Ebrahim ESKANDARI ◽  
Alireza FIROOZ ◽  
Mansour NASSIRI-KASHANI ◽  
Mahmoud Reza JAAFARI ◽  
Amir JAVADI ◽  
...  
Keyword(s):  
Adverse Effect ◽  
Clinical Trial ◽  
Phase I ◽  
Healthy Volunteers ◽  
Amphotericin B ◽  
Phase I Clinical Trial ◽  
Phase 2 ◽  
Double Blind ◽  
Significant Difference ◽  
Phase 2 Clinical Trial

Background: We aimed to evaluate the safety of SinaAmpholeish in a double-blind, randomized, phase 1 clinical trial in healthy human volunteers. Methods: The study was carried out in DermaLab of Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, Iran in 2012. A topical Nano-liposomal formulation of 0.4% Amphotericin B was developed against Leishmania under trade name of SinaAmpholeish. In this randomized, double-blind, right-left, comparative, phase I clinical trial, in 2 steps; 7 and 20 healthy volunteers were recruited and applied SinaAmpholeish on the right and its vehicle on the left volar side of forearm, twice a day for one week or 3 times a day for two weeks. Seven biophysical skin parameters were measured in standard conditions before and 2 wk after application. Results: There was no adverse effect when SinaAmpholeish and its vehicle were used twice a day for seven days. However, when were used 3 times a day for two weeks, both SinaAmpholeish and its vehicle induced severe local skin reactions in 2 volunteers leading to discontinuation of application. Mild and temporary local reactions were observed in about half of the application sides and there was no significant difference between SinaAmpholeish and its vehicle. Conclusion: The new formulation is safe and worth to be tested in further phase 2 clinical trial and since there was no adverse effect with twice a day application it was decided to use SinaAmpholeish twice a day in phase 2 clinical trial.

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