Immunogenicity and safety of the homogenous booster shot of a recombinant fusion protein vaccine (V-01) against COVID-19 in healthy adult participants primed with a two-dose regimen

BackgroundRising concerns over waning immunity and reduction in neutralizing activity against variants of concern (VOCs) have contributed to deploying booster doses by different strategies to tackle the COVID-19 pandemic. Preliminary findings from Phase I and II have shown that V-01, a recombinant fusion protein vaccine against COVID-19, exhibited favorable safety and immunogenicity profiles in 1060 adult participants of both younger and senior age. Herein, we aimed to assess the immunogenicity and safety for a booster dose in participants previously primed with a two-dose 10g V-01 regimen (day 0, 21) from phase I trial, providing reassuring data for necessity and feasibility of a homogenous booster dose. MethodsWe conducted a single-arm, open-label trial at the Guangdong Provincial Center for Disease Control and Prevention (Gaozhou, China). Forty-three eligible participants who were previously primed 4-5 months earlier with two-dose 10g V-01 regimen from phase I trial received booster vaccination. We primarily assessed the immunogenicity post-booster vaccination, measured by RBD-binding antibodies using ELISA and neutralizing activity against wild-type SARS-CoV-2 and emerging variants of concern (VOCs) using neutralization assays. We secondarily assessed the safety and reactogenicity of the booster vaccination. ResultsThe third dose of V-01 exhibited significant boosting effects of humoral immune response in participants primed with two-dose 10g V-01 regimen regarding both wild-type SARS-CoV-2 and VOCs. We observed a 60.4-folds increase in neutralizing titres against SARS-CoV-2 of younger adults, with GMTs of 17 (95%CI: 12-23) prior to booster vaccination in comparison to 1017 (95%CI: 732-1413) at day 14 post booster vaccination; and a 53.6-folds increase in that of older adults, with GMTs of 14 (95%CI: 9-20) before booster vaccination in comparison to 729(95%CI: 397-1339) at day 14 post-booster vaccination. The neutralizing titres against SARS-CoV-2 Delta strain also demonstrated a sharp increase from the day of pre booster vaccination to day 14 post booster vaccination, with GMTs of 11 (95%CI:8-15) versus 383 (95%CI:277-531) in younger adults (35.4-folds increase), and 6.5(95%CI: 5-8) versus 300(95%CI:142-631) in older adults (46.0-folds increase), respectively. We also observed a considerable and consistent increase of pseudovirus neutralizing titres against emerging VOCs from day 28 post second vaccination to day 14 post booster vaccination, with GMTs of 206 (95%CI:163-259) versus 607 (95%CI: 478-771) for Alpha strain, 54 (95%CI:38-77) versus 329 (95%CI: 255-425) for Beta strain, 219 (95%CI:157-306) versus 647 (95%CI: 484-865) for Delta strain. Our preliminary findings indicate a homogenous booster dose of V-01 was safe and well-tolerated, with overall adverse reactions being absent or mild-to-moderate in severity, and no grade 3 or worse AEs were related to booster vaccination. ConclusionsA homogenous booster immunization in participants receiving a primary series of two-dose V-01 elicited a substantial humoral immune response against wild-type SARS-CoV-2 and emerging VOCs, along with a favorable safety and reactogenicity profile. Our study provided promising data for a homogenous prime-boost strategy using recombinant protein vaccine to tackle the ongoing pandemic, potentially providing broad protection against emerging VOCs and overcoming waning immunity.

Chemical constituents of Siegesbeckia pubescens / 中国中药杂志

<p><b>OBJECTIVE</b>To study the components in aerial part of Siegesbeckia pubescens.</p><p><b>METHOD</b>The compounds were isolated and purified by silica gel, sephadex LH-20 and other column chromatography. Structures were elucidated by spectroscopic methods.</p><p><b>RESULT</b>Four compounds were isolated from S. pubescens and were characterized as dimethyl-21-ethenetylene-darutigenol-3-O-beta-D-glucopyranosid (1), darutigenol (2), darutoside (3), stigmaster-3-O-beta-D-glucopyranosid (4).</p><p><b>CONCLUSION</b>Compound 1 is a new compound.</p>

Steroidal alkaloids of from Veratrum dahuricum / 中国中药杂志

<p><b>OBJECTIVE</b>To study the steroidal alkaloids in Veratrum dahuricum.</p><p><b>METHOD</b>The compounds were isolated and purified by various column chromatographic methods. Their structures were identified by spectroscopic analysis.</p><p><b>RESULT</b>Five compounds were isolated and identified as (20R, 22S, 25S)-veratra-5,13-dien-3beta-ol (1), angeloylzygadenine (2), 15-O-(2-methylbutanoyl)-3-O-veatroylprotoverine (3), 20-isoveratramine (4), veratramine (5).</p><p><b>CONCLUSION</b>Compound 1 was a new compound, compounds 24 were obtained from the plant for the first time.</p>

The differential diagnosis of abnormal image in the nasopharyngeal cavity and wall / 中华放射学杂志

Objective To improve the differential diagnostic accuracy of abnormal image in the nasopharyngeal cavity and wall.Methods Sixty-five cases with abnormal image in the nasopharyngeal cavity and wall were collected.Twenty cases were proven by operation and pathology.Forty-five cases were proven by biopsy and pathology. All the patients were examined by using CT and (or) MRI. Their imaging features were analyzed in details.Results In 19 cases, polyp and inverted papilloma in the nasal cavity and choanal projected into the nasopharyngeal cavity. Small air bubbles or contact between the lesion and the nasopharyngeal wall were detected in 18 of them. The edge of the polyp was regular, while the margin of the inverted papilloma was irregular. In 11 cases, nasopharyngitis or adenoidal hypertrophy located in the posterosuperior wall. The anterior borders were almost straight or curve toward inside, and the contrast enhanced CT and MRI scans showed that the mucous membrane lines were continuous. Oropharyngitis in the right side spread to the right wall of the nasopharynx without clear borderline and the space occupying effect was little in 1 case. There were 33 cases of nasopharyngeal carcinoma (NPC) and 1 case of non-Hodgkin′s lymphoma (NHL), and the anterior borders of the masses were evaginated like a curve, and most of them were accompanied with shallowing or disappearing of pharyngeal recess and tumefaction of the levator muscle of palatine velum.Conclusion According to the imaging features, most of the abnormalities in the nasopharyngeal cavity and wall can be diagnosed correctly.

Imaging Features of Solitary Enchondroma / 实用放射学杂志

Objective To discuss the clinic and imaging features of solitary enchondroma.Methods Radiography,CT and MRI were performed in 11 cases of solitary enchondroma confirmed by pathology.The imaging findings were retrospectively analysed.Results The tumors in 11 cases localized in metacarpal bone in 3, in bones of fingers in 4, in shaft of humerus in one,in metaphysis of femur in 2 and in metaphysis of tibia in one.Plain radiography showed typical radiographic features including a well defined central lucency in the diaphysis of the metacarpal bones and bones of fingers with calcifications inside the lesions and lobulated contour,the cortex was thinned and cortical expansion also might occur.The lesions appeared as soft tissue density with stippling calcification on CT,low signal intensity on T1WI and mixed mainly high signal intensity on T2WI.A low signal zone around the lesion could be seen on T2WI in one case.Conclusion The qualitative and differential diagnosis of solitary enchondroma can be made mostly by imaging examination.