1.
Safety and immunogenicity of SARS-CoV-2 self-amplifying RNA vaccine expressing an anchored RBD: A randomized, observer-blind phase 1 study.
Akahata, W, Sekida, T, Nogimori, T, Ode, H, Tamura, T, Kono, K, Kazami, Y, Washizaki, A, Masuta, Y, Suzuki, R, et al
Cell reports. Medicine. 2023;(8):101134
Abstract
VLPCOV-01 is a lipid nanoparticle-encapsulated self-amplifying RNA (saRNA) vaccine that expresses a membrane-anchored receptor-binding domain (RBD) derived from the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein. A phase 1 study of VLPCOV-01 is conducted (jRCT2051210164). Participants who completed two doses of the BNT162b2 mRNA vaccine previously are randomized to receive one intramuscular vaccination of 0.3, 1.0, or 3.0 μg VLPCOV-01, 30 μg BNT162b2, or placebo. No serious adverse events have been reported. VLPCOV-01 induces robust immunoglobulin G (IgG) titers against the RBD protein that are maintained up to 26 weeks in non-elderly participants, with geometric means ranging from 5,037 (95% confidence interval [CI] 1,272-19,940) at 0.3 μg to 12,873 (95% CI 937-17,686) at 3 μg compared with 3,166 (95% CI 1,619-6,191) with 30 μg BNT162b2. Neutralizing antibody titers against all variants of SARS-CoV-2 tested are induced. VLPCOV-01 is immunogenic following low-dose administration. These findings support the potential for saRNA as a vaccine platform.
2.
Gastric endoscopic submucosal dissection using sodium carboxymethylcellulose as a new injection substance.
Hikichi, T, Yamasaki, M, Watanabe, K, Nakamura, J, Sato, M, Takagi, T, Suzuki, R, Sugimoto, M, Kikuchi, H, Konno, N, et al
Fukushima journal of medical science. 2016;(1):43-50
Abstract
AIM: To investigate the feasibility of endoscopic submucosal dissection (ESD) using sodium carboxymethylcellulose (SCMC) for gastric cancer. METHODS During October 2011 through April 2013, 98 lesions from 98 patients who underwent ESD using SCMC (ESD-SCMC) for early gastric cancer were enrolled in this study. Two endoscopists, who had each performed fewer than 30 ESD procedures (less-experienced ESD physicians), performed ESD-SCMC under the supervision of two experts. The primary outcome was the en bloc resection rate. Secondary outcomes included the complete resection rate, the procedural time, the bleeding rate after SCMC injection, and complications. Patient characteristics, time necessary for hemostasis after SCMC injection, rate of treatment completion by less-experienced ESD physicians alone, and the effects of SCMC during ESD and on resected specimens were also evaluated. RESULTS The en bloc resection rate was 100%. Among these resections, 87.8% of the cases were completed by a less-experienced ESD physician alone. The complete resection rate was 98.0%. The mean total procedural time was 75.4 min. The mean incidence of intraoperative bleeding following SCMC local injection was 1.7 times. No bleeding was observed after SCMC injection in 29.6% of cases (29/98). Five complications occurred: one case of microperforation (1.0%) and four cases of postoperative bleeding (4.0%). SCMC remained in the submucosa. The submucosa was readily manipulated when the deep submucosa was dissected, even after placing the specimen on a slide. CONCLUSION ESD-SCMC is feasible for the resection of early gastric cancer.
3.
Oral rabeprazole administration on a procedure day suppresses bleeding after endoscopic submucosal dissection for gastric neoplasms.
Hikichi, T, Sato, M, Watanabe, K, Nakamura, J, Takagi, T, Suzuki, R, Sugimoto, M, Waragai, Y, Kikuchi, H, Konno, N, et al
Fukushima journal of medical science. 2014;(1):68-74
Abstract
AIM: The efficacy of pre-procedure oral proton pump inhibitor (PPI) administration for gastric endoscopic submucosal dissection (ESD) is unclear. This study evaluated oral PPI administration effectiveness on the day of ESD to prevent post-ESD bleeding. METHODS This study examined 55 patients who underwent ESD for gastric neoplasm. Group A comprised 31 patients who took rabeprazole sodium (RPZ) 20 mg/day beginning 7-8 hr before ESD. Group B comprised 24 who took RPZ 20 mg/day beginning three days before ESD. Gastric pH (G-pH) was measured at one month before ESD (pre-ESD pH), immediately before ESD (ESD pH), and seven days after ESD (post-ESD pH). The post-ESD bleeding rate and changes in G-pH were recorded. RESULTS No significant difference in post-ESD bleeding rates was found (Group A 3.2%, Group B 0%). ESD pH and post-ESD pH were significantly higher than pre-ESD pH in both groups (P<0.001). The ESD pH for Group A was higher than 6 (6.5±1.1), providing hemostasis for intragastric bleeding. CONCLUSIONS Oral RPZ administration on the day of gastric ESD can suppress post-ESD bleeding equivalently to administration three days before ESD.