1.Correlation of serum lipid soluble vitamin levels with body fat mass percentage and lifestyle among primary school students
NI Yiping, ZHU Bo, YOU Jie, ZHANG Wen, WANG Li, JI Xiang
Chinese Journal of School Health 2025;46(11):1564-1568
Objective:
To analyze the correlation between the levels of vitamin A, vitamin D, vitamin E with body fat mass percentage(FMP) as well as lifestyle factors among primary school students, so as to provide references for exploring the vitamin nutritional status of primary school students and its potential influencing factors.
Methods:
From September 1 to October 30, 2021, a cluster sampling method was used to select 750 thirdgrade students from eight primary schools in Luohu District, Shenzhen. Their body composition was measured, and blood samples were collected to detect the serum levels of vitamin A, vitamin D, and vitamin E using a mass spectrometer. Dietary and exercise habits were collected through questionnaires. Mann-Whitney U test and Kruskal-Wallis H rank sum test were used for inter group comparisons, spearman correlation was used for correlation analysis,and Logistic regression model was used to analyze the association between lifestyle and vitamin content.
Results:
The overall level of vitamin A in school aged children was 0.4 (0.4, 0.5) mg/L, with a deficiency rate of 0 and a marginal deficiency rate of 5.1%; the level of vitamin D was 26.0 (22.0, 30.0) ng/mL, with a deficiency rate of 0.4% and an insufficiency rate of 12.7%; the content of vitamin E was 11.8 (10.1, 13.5) mg/L, with an insufficiency rate of 0.8%. Spearman correlation analysis showed that vitamin A was positively correlated with FMP in the total population, boys, girls, and normal weight population ( r =0.18, 0.18, 0.20, 0.10), and vitamin D was positively correlated with FMP in the total population and obese population ( r =0.08,0.16)(all P <0.05). Logistic regression analysis showed that marginal deficiency of vitamin A was associated with consumption of animal, snack, and dairy/egg/bean foods ( OR =0.45, 0.55, 0.59); whether vitamin D was deficient was influenced by gender ( OR =2.65) and exercise ( OR = 1.96 ) (all P <0.05).
Conclusion
Vitamin A, vitamin D and vitamin E levels are associated with body fat percentage, with significant variations in vitamin status among individuals of different body types, necessitating targeted supplementation.
2.Application of superior iliac fascia block of inguinal ligament combined with patient controlled intravenous analgesia in elderly patients after hip arthroplasty
Fu YAO ; Yun-Hua SHUI ; Ji-Lin XIANG ; Bo YANG
China Journal of Orthopaedics and Traumatology 2024;37(5):482-487
Objective To compare the effect of patient-controlled intravenous analgesia(PCIA)and superior inguinal liga-ment iliac fascia block combined with PCIA after hip replacement in the elderly.Methods Total of 82 elderly patients were treated with hip arthroplasty from June 2019 to June 2021 and randomly divided into observation group and control group.There were 42 patients in control group,including 18 males and 24 females,aged from 60 to 78 years old with an average of(70.43±3.67)years old,28 femoral neck fractures and 14 femoral head necrosis,who received PCIA.The study group consist-ed of 42 cases,including 20 males and 22 females,aged from 61 to 76 years old with an average of(69.68±3.74)years old,25 femoral neck fractures and 17 femoral head necrosis,who received superior inguinal ligament iliac fascia block combined with PCIA.Pain visual analogue scale(VAS)and Ramesay sedation scores at2h,6h,12h,24h and 48 h after operation were e-valuated.In addition,the follow-up results of the total consumption of sufentanil and the total number of PCIA compressions at 48 hours after operation,the first time of landing after surgery,the time of hospital stay,the incidence of adverse reactions,the satisfaction with analgesia of two groups were observed.Results All patients were followed up for 9 to 24 months with an aver-age of(13.85±2.67)months.There was no significant difference in operation time and intraoperative bleeding between two groups(P>0.05).There was no difference in VAS between two groups at 2 hours after operation(P>0.05),and the VAS of the study group at 6 h,12 h,24 h and 48 h after operation were lower than those of the control group(P<0.05).The Ramesay seda-tion scores of the study group at 2 h,6 h and 12 h after operation were higher than those of the control group(P<0.05),and there were no differences in Ramesay score between two groups at 24 h and 48 h after operation(P>0.05).The consumption of sufentanil in the study group within 48 hours after operation was lower than that in the control group(P<0.05),and PCIA com-pression times were lower than those in the control group(P<0.05),and the time of first landing was earlier than that in the control group(P<0.05).There was no significant difference in hospital stay,adverse reaction rate,complications between two groups(P>0.05).The satisfaction of analgesia in the study group was higher than that in the control group(P<0.05).Conclu-sion Superior iliac fascia block of inguinal ligament combined with PCIA has significant analgesic and sedative effects after hip arthroplasty in the elderly.It can reduce the amount of sufentanil used and the total number of PCIA compressions,which is conducive to the early activity of patients out of bed,improve the satisfaction of analgesia.
3.Effect of CD8+CD28-T Cells on Acute Graft-Versus-Host Disease after Haploidentical Hematopoietic Stem Cell Transplantation
An-Di ZHANG ; Xiao-Xuan WEI ; Jia-Yuan GUO ; Xiang-Shu JIN ; Lin-Lin ZHANG ; Fei LI ; ZHEN-Yang GU ; Jian BO ; Li-Ping DOU ; Dai-Hong LIU ; Meng LI ; Chun-Ji GAO
Journal of Experimental Hematology 2024;32(3):896-905
Objective:To investigate the effect of CD8+CD28-T cells on acute graft-versus-host disease(aGVHD)after haploidentical hematopoietic stem cell transplantation(haplo-HSCT).Methods:The relationship between absolute count of CD8+CD28-T cells and aGVHD in 60 patients with malignant hematological diseases was retrospectively analyzed after haplo-HSCT,and the differences in the incidence rate of chronic graft-versus host disease(cGVHD),infection and prognosis between different CD8+CD28-T absolute cells count groups were compared.Results:aGVHD occurred in 40 of 60 patients after haplo-HSCT,with an incidence rate of 66.67%.The median occurrence time of aGVHD was 32.5(20-100)days.At 30 days after the transplantation,the absolute count of CD8+CD28-T cells of aGVHD group was significantly lower than that of non-aGVHD group(P=0.03).Thus the absolute count of CD8+CD28-T cells at 30 days after transplantation can be used to predict the occurrence of aGVHD to some extent.At 30 days after transplantation,the incidence rate of aGVHD in the low cell count group(CD8+CD28-T cells absolute count<0.06/μl)was significantly higher than that in the high cell count group(CD8+CD28-T cells absolute count ≥0.06/μl,P=0.011).Multivariate Cox regression analysis further confirmed that the absolute count of CD8+CD28-T cells at 30 days after transplantation was an independent risk factor for aGVHD,and the risk of aGVHD in the low cell count group was 2.222 times higher than that in the high cell count group(P=0.015).The incidence of cGVHD,fungal infection,EBV infection and CMV infection were not significantly different between the two groups with different CD8+CD28-T cells absolute count.The overall survival,non-recurrent mortality and relapse rates were not significantly different between different CD8+CD28-T cells absolute count groups.Conclusion:Patients with delayed CD8+CD28-T cells reconstitution after haplo-HSCT are more likely to develop aGVHD,and the absolute count of CD8+CD28-T cells can be used to predict the incidence of aGVHD to some extent.The absolute count of CD8+CD28-T cells after haplo-HSCT was not associated with cGVHD,fungal infection,EBV infection,and CMV infection,and was also not significantly associated with the prognosis after transplantation.
4.Epidemiologic characteristics and drug resistance of isolated from blood culture escherichia coli in a hospital in Qinghai Province from 2016 to 2022.
Bo Jie YANG ; Xiang Ren A ; Xiao Ming MU ; Peng CHENG ; Jian Wu ZHOU ; Ji Deng MA ; Yan Ke LYU
Chinese Journal of Preventive Medicine 2023;57(12):2102-2109
Objective: To explore the drug resistance of Isolated From Blood Culture Escherichia coli (E. coli) in a hospital in Qinghai over the past seven years, to evaluate the ability of matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) to analyze the homologous origin of E. coli, and to establish a protein fingerprint library to match with it, adjuvant clinical experience medication so as to provide the basis for the prevention and control of hospital-acquired infections. Methods: Retrospective analysis of blood cultures sent to hospitals from January 2016 to December 2022. Drug resistance and resistance changes in E. coli.A total of 1 841 E. coli strains were isolated from Qinghai Provincial People's Hospital from January 2016 to December 2022; all strains were identified by MALDI-TOF MS, and the VITEK2.0 drug sensitivity analyzer was applied for drug sensitivity analysis of the strains, and the mass spectrometry homology analysis and self-constructed protein fingerprint library were carried out by MALDI-Biotyper software; the protein fingerprint library was built by using WHONET5.6 software was used to statistically analyze the drug sensitivity results, SPSS23.0 software was used to analyze the relationship between fingerprint typing and drug sensitivity, and the χ2 test was used for intergroup comparisons. Results: A total of 1 841 strains of E. coli were detected in 4 582 positive blood culture specimens from January 2016 to December 2022, with a detection rate of 40.17%; the resistance rate of E. coli from blood sources to piperacillin/tazobactam and ceftriaxone was on the rise, and it was slightly decreased to cefepime, amikacin, levofloxacin, and sulfamethoxazole, and there was not much change to the rest of the drugs; After MALDI-Biotyper clustering analysis, the 1841 E. coli strains from Isolated From Blood Culture were classified into two major clusters and five subtypes, of which type Ⅰa1 accounted for about 40%, type Ⅰa2 accounted for about 2.7%, type Ⅰb accounted for about 3.8, type Ⅱa accounted for about 46%, and type Ⅱb accounted for about 7.5%. The detection rate of type Ⅰa1 E. coli was higher in general surgery (50.45%) and emergency surgery (50.92%), and the detection rate of type Ⅰb E. coli was higher in emergency medicine(10.05%)than in other departments. The drug sensitivity results of different subtypes were compared with each other, the resistance rate of type Ⅰa1 E. coli to cefepime was 21.3% higher than that of the remaining four types, and the difference was statistically significant (χ2=37.74,P=0.000); the resistance rate of type Ⅱ E. coli(>60%) to sulfamethoxazole was higher than that of type Ⅰ (<60%) as a whole, and the difference was statistically significant (χ2=15.248,P=0.004); and a preliminary database of homologous protein fingerprints of E. coli has been established E. coli homologous protein fingerprint library and validated. The drug susceptibility results of 1 288 E. coli strains in the validation set were statistically analyzed and compared with those in the training set. There was no significant difference(P>0.05). Conclusion: In recent years, the resistance rate of E. coli isolated from a hospital in Qinghai province to piperacillin/Tazobactam, cefepime, amicacin and other antibiotics has changed greatly. A fingerprint database of E. coli homologous protein was established, and it was found that the drug sensitivity data of E. coli were different among different fingerprint types. According to drug sensitivity, drug use could assist clinical experience and provide evidence for prevention and control of hospital illness.
Humans
;
Blood Culture
;
Escherichia coli
;
Cefepime
;
Retrospective Studies
;
Drug Resistance
;
Sulfamethoxazole
;
Piperacillin
;
Tazobactam
5.AKT inhibitor Hu7691 induces differentiation of neuroblastoma cells.
Shaowei BING ; Senfeng XIANG ; Zhimei XIA ; Yilong WANG ; Zhonghai GUAN ; Jinxin CHE ; Aixiao XU ; Xiaowu DONG ; Ji CAO ; Bo YANG ; Jinhu WANG ; Qiaojun HE ; Meidan YING
Acta Pharmaceutica Sinica B 2023;13(4):1522-1536
While neuroblastoma accounts for 15% of childhood tumor-related deaths, treatments against neuroblastoma remain scarce and mainly consist of cytotoxic chemotherapeutic drugs. Currently, maintenance therapy of differentiation induction is the standard of care for neuroblastoma patients in clinical, especially high-risk patients. However, differentiation therapy is not used as a first-line treatment for neuroblastoma due to low efficacy, unclear mechanism, and few drug options. Through compound library screening, we accidently found the potential differentiation-inducing effect of AKT inhibitor Hu7691. The protein kinase B (AKT) pathway is an important signaling pathway for regulating tumorigenesis and neural differentiation, yet the relation between the AKT pathway and neuroblastoma differentiation remains unclear. Here, we reveal the anti-proliferation and neurogenesis effect of Hu7691 on multiple neuroblastoma cell lines. Further evidence including neurites outgrowth, cell cycle arrest, and differentiation mRNA marker clarified the differentiation-inducing effect of Hu7691. Meanwhile, with the introduction of other AKT inhibitors, it is now clear that multiple AKT inhibitors can induce neuroblastoma differentiation. Furthermore, silencing AKT was found to have the effect of inducing neuroblastoma differentiation. Finally, confirmation of the therapeutic effects of Hu7691 is dependent on inducing differentiation in vivo, suggesting that Hu7691 is a potential molecule against neuroblastoma. Through this study, we not only define the key role of AKT in the progression of neuroblastoma differentiation but also provide potential drugs and key targets for the application of differentiation therapies for neuroblastoma clinically.
6.Comparison of early clinical effects between direct superior approach and posterolateral approach in hemiarthroplasty of femoral neck fracture in the elderly.
Xiang PENG ; Feng SHUANG ; Hao LI ; Yin-Chu SHAO ; Wei HU ; Ji-Chun SHAN ; Di YANG ; De-En WAN ; Wen-Bo XU
China Journal of Orthopaedics and Traumatology 2023;36(11):1021-1025
OBJECTIVE:
To compare and analyze the early clinical effect of direct superior approach(DSA) and posterior lateral approach (PLA) in hemiarthroplasty for elderly patients with femoral neck fracture.
METHODS:
The clinical data of 72 elderly patients with femoral neck fracture who underwent hemiarthroplasty from January 2020 to December 2021 were retrospectively analyzed. Among them, 36 patients were operated through minimally invasive DSA including 10 males and 26 females with an average age of (82.82±4.05) years old; the other 36 patients underwent traditional PLA including 14 males and 22 females with an average age of (82.79±3.21) years old. The perioperative related indexes and Harris scores during follow-up between two groups were compared.
RESULTS:
Comparison of operation time between two groups, (79.41±17.39) min of DSA group was shorter than(98.45±26.58) min of PLA group;incision length (8.33±2.69) cm was shorter than (11.18±1.33) cm of PLA group;intraoperative blood loss (138.46±71.58) ml was less than (173.51±87.17) ml of PLA group, initial landing time (3.04±0.95) d was earlier than (4.52±1.10) d of PLA group, hospitalization time (8.70±1.89) d was shorter than (10.67±2.35) d of PLA group(P<0.05). There was no statistical difference in Harris score between two groups before operation(P>0.05), but Harris score in DSA group was higher than that of PLA group at 1 month after operation(P<0.05), but at 12 months after operation, the difference was not statistically significant between two groups(P>0.05).
CONCLUSION
Compared with PLA, DSA is superior in clinical indexes such as operation time, intraoperative blood loss, incision length, first landing time, length of hospitalization and Harris score in the first month after operation in hemi hip replacement, and has comparative advantages in promoting early postoperative rehabilitation of elderly patients with femoral neck.
Male
;
Female
;
Humans
;
Aged
;
Aged, 80 and over
;
Blood Loss, Surgical
;
Hemiarthroplasty
;
Retrospective Studies
;
Arthroplasty, Replacement, Hip
;
Femoral Neck Fractures/surgery*
;
Treatment Outcome
7.Epidemiologic characteristics and drug resistance of isolated from blood culture escherichia coli in a hospital in Qinghai Province from 2016 to 2022.
Bo Jie YANG ; Xiang Ren A ; Xiao Ming MU ; Peng CHENG ; Jian Wu ZHOU ; Ji Deng MA ; Yan Ke LYU
Chinese Journal of Preventive Medicine 2023;57(12):2102-2109
Objective: To explore the drug resistance of Isolated From Blood Culture Escherichia coli (E. coli) in a hospital in Qinghai over the past seven years, to evaluate the ability of matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) to analyze the homologous origin of E. coli, and to establish a protein fingerprint library to match with it, adjuvant clinical experience medication so as to provide the basis for the prevention and control of hospital-acquired infections. Methods: Retrospective analysis of blood cultures sent to hospitals from January 2016 to December 2022. Drug resistance and resistance changes in E. coli.A total of 1 841 E. coli strains were isolated from Qinghai Provincial People's Hospital from January 2016 to December 2022; all strains were identified by MALDI-TOF MS, and the VITEK2.0 drug sensitivity analyzer was applied for drug sensitivity analysis of the strains, and the mass spectrometry homology analysis and self-constructed protein fingerprint library were carried out by MALDI-Biotyper software; the protein fingerprint library was built by using WHONET5.6 software was used to statistically analyze the drug sensitivity results, SPSS23.0 software was used to analyze the relationship between fingerprint typing and drug sensitivity, and the χ2 test was used for intergroup comparisons. Results: A total of 1 841 strains of E. coli were detected in 4 582 positive blood culture specimens from January 2016 to December 2022, with a detection rate of 40.17%; the resistance rate of E. coli from blood sources to piperacillin/tazobactam and ceftriaxone was on the rise, and it was slightly decreased to cefepime, amikacin, levofloxacin, and sulfamethoxazole, and there was not much change to the rest of the drugs; After MALDI-Biotyper clustering analysis, the 1841 E. coli strains from Isolated From Blood Culture were classified into two major clusters and five subtypes, of which type Ⅰa1 accounted for about 40%, type Ⅰa2 accounted for about 2.7%, type Ⅰb accounted for about 3.8, type Ⅱa accounted for about 46%, and type Ⅱb accounted for about 7.5%. The detection rate of type Ⅰa1 E. coli was higher in general surgery (50.45%) and emergency surgery (50.92%), and the detection rate of type Ⅰb E. coli was higher in emergency medicine(10.05%)than in other departments. The drug sensitivity results of different subtypes were compared with each other, the resistance rate of type Ⅰa1 E. coli to cefepime was 21.3% higher than that of the remaining four types, and the difference was statistically significant (χ2=37.74,P=0.000); the resistance rate of type Ⅱ E. coli(>60%) to sulfamethoxazole was higher than that of type Ⅰ (<60%) as a whole, and the difference was statistically significant (χ2=15.248,P=0.004); and a preliminary database of homologous protein fingerprints of E. coli has been established E. coli homologous protein fingerprint library and validated. The drug susceptibility results of 1 288 E. coli strains in the validation set were statistically analyzed and compared with those in the training set. There was no significant difference(P>0.05). Conclusion: In recent years, the resistance rate of E. coli isolated from a hospital in Qinghai province to piperacillin/Tazobactam, cefepime, amicacin and other antibiotics has changed greatly. A fingerprint database of E. coli homologous protein was established, and it was found that the drug sensitivity data of E. coli were different among different fingerprint types. According to drug sensitivity, drug use could assist clinical experience and provide evidence for prevention and control of hospital illness.
Humans
;
Blood Culture
;
Escherichia coli
;
Cefepime
;
Retrospective Studies
;
Drug Resistance
;
Sulfamethoxazole
;
Piperacillin
;
Tazobactam
8.Analysis of Chemical Constituents in Different Parts of Gentiana straminea Based on UPLC-Q-TOF-MS/MS
Xiang-ping LIANG ; Shuang JI ; Shao-bo DU ; Zhi-qiang DONG ; Xiao-wen CHEN ; Ai-fang YANG ; Hui-chun XIE
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(8):139-148
ObjectiveUltra-performance liquid chromatography-quadrupole-time-of-flight tandem mass spectrometry (UPLC-Q-TOF-MS/MS) was used to analyze the chemical constituents in the aerial part and roots of Gentiana straminea from different areas of Qinghai province, and the main chromatographic peaks and differential components of different parts were identified. MethodThe chromatographic separation was performed on a Waters ACQUITY UPLC HSS T3 column (2.1 mm×100 mm, 1.8 μm) with 0.1% formic acid aqueous solution (A)-acetonitrile (B) as the mobile phase for gradient elution (0-1 min, 1%-13%B; 1-5 min, 13%-18%B; 5-7 min, 18%-50%B; 7-9.5 min, 50%-60%B; 9.5-11 min, 60%-99%B; 11-14 min; 99%B; 14-15 min, 99%-1%B; 15-16 min, 1%B), the column temperature at 40 ℃, and the flow rate of 0.3 mL·min-1. Electrospray ionization (ESI) and negative ion full scan mode were selected for the mass spectrometric conditions to analyze the samples, and the detection range was m/z 50-1 200. Chemical constituents of the aerial part were qualitatively analyzed with the reference substances, literature information and ChemSpider. Principal component analysis (PCA) and orthogonal partial least squares discriminant analysis (OPLS-DA) were used to analyze the classification trend, correlation and differential chemical components between aerial part and roots of G. straminea. ResultA total of 68 components, including 24 iridoids, 13 flavonoids, 8 triterpenoids, 6 xanthones, 5 fatty acids, 4 saccharides, 3 phenolic glycosides, 2 alkaloids, 2 sterols and 1 lignan, were preliminarily identified from the aerial part of G. straminea. Among them, 42 components were firstly reported in 4 Gentiana species included in the 2020 edition of Chinese Pharmacopoeia. Eight differential components were screened out, namely sucrose, maltotriose, loganic acid, shanzhiside methyl ester, 6′-O-β-D-glucosylgentiopicroside, swertiamarin, gentiopicrin and isovitexin. ConclusionThe aerial part of G. straminea is rich in chemical constituents and has good medicinal potential. There were significant differences in the chemical components between the aerial part and roots of G. straminea, and the main differential components were iridoids, which could provide a basis for exploring efficacy differences in different parts of G. straminea.
9. Research progress on the exposure pathway and toxic effect of microplastics
Dong-ye YU ; Yu-qin LUO ; Xiang-hui WANG ; Bo-xuan LIANG ; Yu-ji HUANG ; Xi LIN ; Yi-zhou ZHONG ; Zhen-lie HUANG
China Occupational Medicine 2021;48(01):98-102
Global plastics production has been increasing year by year. Due to the large quantity of plastics and the difficulty of their degradation, plastics are continuously accumulated in the environment. Therefore, plastic waste has become one of the most serious threats to the global environment. Microplastics can be absorbed into organisms through the mouth, respiratory tract and skin, causing organ(intestine, liver) toxicity, reproductive and developmental toxicity, and neurotoxicity. Moreover, microplastics can also take up other pollutants distributed in the surrounding environment, such as heavy metals and organic pollutants, jointly exerting combined toxic effects. The extracts of microplastics, including microplastics unstable polymers and additives, also have toxic effects. The molecular mechanisms involved in the toxic effects induced by microplastics include oxidative stress, inflammation, disturbance of intestinal flora, disturbance of gene expression, and others.
10.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.
Ya-Jun SHU ; Jian-Feng HE ; Rong-Juan PEI ; Peng HE ; Zhu-Hang HUANG ; Shao-Min CHEN ; Zhi-Qiang OU ; Jing-Long DENG ; Pei-Yu ZENG ; Jian ZHOU ; Yuan-Qin MIN ; Fei DENG ; Hua PENG ; Zheng ZHANG ; Bo WANG ; Zhong-Hui XU ; Wu-Xiang GUAN ; Zhong-Yu HU ; Ji-Kai ZHANG
Chinese Medical Journal 2021;134(16):1967-1976
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).
Aged
;
Antibodies, Viral
;
COVID-19/therapy*
;
COVID-19 Vaccines
;
Double-Blind Method
;
Humans
;
Immunization, Passive
;
Recombinant Fusion Proteins
;
SARS-CoV-2


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