Immunogenicity and safety of a recombinant fusion protein vaccine (V-01) against coronavirus disease 2019 in healthy adults: a randomized, double-blind, placebo-controlled, phase II trial / 中华医学杂志(英文版)

BACKGROUND@#Innovative coronavirus disease 2019 (COVID-19) vaccines, with elevated global manufacturing capacity, enhanced safety and efficacy, simplified dosing regimens, and distribution that is less cold chain-dependent, are still global imperatives for tackling the ongoing pandemic. A previous phase I trial indicated that the recombinant COVID-19 vaccine (V-01), which contains a fusion protein (IFN-PADRE-RBD-Fc dimer) as its antigen, is safe and well tolerated, capable of inducing rapid and robust immune responses, and warranted further testing in additional clinical trials. Herein, we aimed to assess the immunogenicity and safety of V-01, providing rationales of appropriate dose regimen for further efficacy study.@*METHODS@#A randomized, double-blind, placebo-controlled phase II clinical trial was initiated at the Gaozhou Municipal Centre for Disease Control and Prevention (Guangdong, China) in March 2021. Both younger (n = 440; 18-59 years of age) and older (n = 440; ≥60 years of age) adult participants in this trial were sequentially recruited into two distinct groups: two-dose regimen group in which participants were randomized either to follow a 10 or 25 μg of V-01 or placebo given intramuscularly 21 days apart (allocation ratio, 3:3:1, n = 120, 120, 40 for each regimen, respectively), or one-dose regimen groups in which participants were randomized either to receive a single injection of 50 μg of V-01 or placebo (allocation ratio, 3:1, n = 120, 40, respectively). The primary immunogenicity endpoints were the geometric mean titers of neutralizing antibodies against live severe acute respiratory syndrome coronavirus 2, and specific binding antibodies to the receptor binding domain (RBD). The primary safety endpoint evaluation was the frequencies and percentages of overall adverse events (AEs) within 30 days after full immunization.@*RESULTS@#V-01 provoked substantial immune responses in the two-dose group, achieving encouragingly high titers of neutralizing antibody and anti-RBD immunoglobulin, which peaked at day 35 (161.9 [95% confidence interval [CI]: 133.3-196.7] and 149.3 [95%CI: 123.9-179.9] in 10 and 25 μg V-01 group of younger adults, respectively; 111.6 [95%CI: 89.6-139.1] and 111.1 [95%CI: 89.2-138.4] in 10 and 25 μg V-01 group of older adults, respectively), and remained high at day 49 after a day-21 second dose; these levels significantly exceed those in convalescent serum from symptomatic COVID-19 patients (53.6, 95%CI: 31.3-91.7). Our preliminary data show that V-01 is safe and well tolerated, with reactogenicity predominantly being absent or mild in severity and only one vaccine-related grade 3 or worse AE being observed within 30 days. The older adult participants demonstrated a more favorable safety profile compared with those in the younger adult group: with AEs percentages of 19.2%, 25.8%, 17.5% in older adults vs. 34.2%, 23.3%, 26.7% in younger adults at the 10, 25 μg V-01 two-dose group, and 50 μg V-01 one-dose group, respectively.@*CONCLUSIONS@#The vaccine candidate V-01 appears to be safe and immunogenic. The preliminary findings support the advancement of the two-dose, 10 μg V-01 regimen to a phase III trial for a large-scale population-based evaluation of safety and efficacy.@*TRIAL REGISTRATION@#http://www.chictr.org.cn/index.aspx (No. ChiCTR2100045107, http://www.chictr.org.cn/showproj.aspx?proj=124702).

Role of Contrast-enhanced Ultrasound in the Evaluation of Inflammatory Arthritis / 中华医学杂志(英文版)

<p><b>OBJECTIVE</b>Contrast-enhanced ultrasound (CEUS) is a well-established imaging modality which has been put into clinical use in recent years with the development of second-generation contrast agent and imaging devices, and its applications in the assessment of inflammatory arthritis, such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, have provoked abundant discussion and researches among radiologists and rheumatologists. To summarize the achievements of clinical studies on CEUS in the application of arthritis, and to keep up with the latest progresses of the imaging technique, we reviewed the literature in recent years, hoping to establish the role of CEUS in joint diseases.</p><p><b>DATA SOURCES</b>PubMed and EMBASE.</p><p><b>STUDY SELECTION</b>We searched the database with the conditions "contrast-enhanced ultrasound AND arthritis" with the time limitation of recent 10 years. Clinical studies applying CEUS in inflammatory arthritis and review articles about development of CEUS in joint diseases in English were selected.</p><p><b>RESULTS</b>As it is proved by most studies in recent years, by delineating microvasculature within the inflamed joints, CEUS can indicate early arthritis with high sensitivity and specificity. Moreover, the imaging of CEUS has been proved to be consistent with histopathological changes of inflammatory arthritis. Quantitative analysis of CEUS permits further evaluation of disease activity. CEUS also plays a significant role in the therapeutic monitoring of the disease, which has been backed up by a number of studies.</p><p><b>CONCLUSIONS</b>CEUS may be a new choice for the rheumatologists to evaluate inflammatory arthritis, because of its low price, ability to provide dynamic pictures, and high sensitivity to angiogenesis. It can also be applied in disease classification and therapeutic monitoring. More studies about CEUS need to be done to set up the diagnostic standards.</p>

Ultrasonic characteristics of intravenous leiomyomatosis with intracardiac extension / 中国医学科学院学报

<p><b>OBJECTIVE</b>To explore the sonographic characteristics of intraveous leiomyomatosis (IVL) with intracardiac extension and improve its diagnosis.</p><p><b>METHODS</b>The clinical and sonographic data of 13 female patients with pathologically confirmed IVL with intracardiac extension who were treated in our hospital between 2002 and 2012 were retrospectively analyzed. These patients aged 44 years old (range: 38-49 years), and 10 of them were first-episode patients and the remaining 3 were recurrent patients. Eight patients had a history of hysterectomy for leiomyoma.</p><p><b>RESULTS</b>The first-episode symptoms included exertional chest tightness and shortness of breath (n=5), abdominal distention and edema of low extermity (n=4), exertional palpitation of cardiac origin (n=3), and menorrhagia (n=1). Ultrasonography showed that all patients had isoechoic or hypoechoic tumors extended through the inferior vena cava into right heart chambers (62% in right atrium alone and 38% in right ventricle and atrium). Nine masses in right heart chamber (69.2%) were oval and 4 (30.8%) were serpentine, which were all with well-demarcated borders and most (80%) with heteroechogenic texture. Ten patients had hypoechoic or mixed echoic tumors in pelvic cavity or uterus, and 6 of them had abundant blood flow.</p><p><b>CONCLUSIONS</b>IVL with intracardiac extension has certain sonographic characteristics. Ultrasonography is a valuable tool in the diagnosis of IVL with intracardiac extension.</p>

Sonographic features of lymphoma in the abdominal lymph nodes / 中国医学科学院学报

<p><b>OBJECTIVE</b>To summarize the sonographic features of the lymphoma in the abdominal lymph nodes.</p><p><b>METHOD</b>The clinical data and sonographic findings of 41 lymphoma patients with original appearance of abdominal mass or lymphadenectasis were retrospectively analyzed.</p><p><b>RESULTS</b>Among these 41 cases, the retroperitoneal and mesenteric lymph nodes were most commonly involved.These patients were divided into two types according to sonographic appearances:solitary mass(n=14) and multiple nodules(n=27) .Solitary hypoechoic mass in abdomen was found in the former type, mostly with irregular or lobular shape, and the inner echo was often heterogenous.The typical appearances of the latter type were multiple enlarged lymph nodes, mostly round or oval, with homogeneous inner echo and clear margins.Some other sonographic characteristics were also helpful for the diagnosis of lymphoma, such as cobblestone sign, intranodular reticulation, vessels-embedded sign, and hilar vascularity.</p><p><b>CONCLUSION</b>Ultrasonography can provide useful information in the diagnosis of the lymphoma in the abdominal lymph nodes.</p>

Ultrasonographic characteristics of intraductal papillary mucinous neoplasm of the pancreas / 中国医学科学杂志(英文版)

<p><b>OBJECTIVE</b>To analyze the clinical and ultrasonographic imaging features of intraductal papillary mucinous neoplasm (IPMN) of the pancreas.</p><p><b>METHODS</b>Twelve patients with IPMN underwent surgery between May 2005 and December 2008, including 4 (33.3%) with adenoma and 8 (66.7%) with adenocarcinoma. IPMN was classified preoperatively into 3 types based on sonographic findings of different sites: main duct, branch duct, and combined type. All clinical presentations and ultrasonographic findings of those patients were reviewed and the correlation between ultrasonographic findings and histopathological results was analyzed.</p><p><b>RESULTS</b>There were 9 men and 3 women with a mean age of 60.1 +/- 9.6 years (range, 32-73). Of all the 12 patients with IPMN, 9 (75.0%) had experienced some symptoms of epigastric discomfort and/or pain as well as backache; 7 cases were with medical history of acute pancreatitis, 5 cases with diabetes, 4 cases with elevated CA19-9, and 2 cases with steatorrhea. All lesions of IPMN have been revealed by transabdominal ultrasonography. The mean diameters of the lesions were 1.4 +/- 0.8 cm (range, 0.5-2.0) and 6.3 +/- 6.0 cm (range, 2.0-20.0) in adenomas and adenocarcinomas, respectively. And the mean diameters of the main duct in adenomas and adenocarcinomas were 1.0 +/- 0.8 cm and 1.6 +/- 1.0 cm, respectively. Among the 4 adnomas, 3 (75.0%) cases were classified as branch type based on sonographic findings, and 2 were demonstrated as mural nodules in which no color signals was detected. Among the 8 adenocarcinomas, 5 (62.5%) cases were classified as main duct type, and 3 (37.5%) as combined type. In 7 of the 8 adenocarcinomas, mural nodules were detected within the dilated ducts or cysts of the lesions in which color flow signals were detected.</p><p><b>CONCLUSIONS</b>Transabdominal ultrasonography can reveal the pancreatic cystic lesions of IPMN as well as dilated pancreatic ducts. Some characteristics should be noticed as suggesting the possibility of malignancy: clinical symptoms of pancreatic insufficiency, large tumor size, and mural nodules with color Doppler flow signals. Transabdominal ultrasonography could be a useful tool to help diagnose and make appropriate management of IPMN.</p>