简介：AbstractBackground:Despite almost two decades of well-funded and comprehensive response efforts by the Chinese Government, human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) remains a major problem in China. Yet, few studies have recently examined long-term trends in HIV/AIDS prevalence, incidence, and mortality at the national level. This study aimed to determine the prevalence, incidence, and mortality trends for HIV/AIDS over the past 28 years in China.Methods:We conducted a descriptive, epidemiological, secondary analysis of the Global Burden of Diseases, Injuries, and Risk Factors Study 2017 data. To evaluate trends in prevalence, incidence, and mortality over the study period from 1990 to 2017, we calculated values for annual percentage change (APC) and corresponding 95% confidence intervals (CIs) using joinpoint regression analysis.Results:A significant increase in HIV/AIDS prevalence was observed for 1990 to 2009 (APC: 10.7; 95% CI: 10.4, 11.0; P < 0.001), and then remained stable for 2009 to 2017 (APC: 0.7; 95% CI: -0.3, 1.7; P = 0.1). A significant increase in HIV incidence was also observed for 1990 to 2005 (APC: 13.0; 95% CI: 12.6, 13.4; P < 0.001), and then a significant decrease was detected for 2005 to 2017 (APC: -6.5; 95% CI: -7.0, -6.1; P < 0.001). A significant increase in AIDS-related mortality rate was detected for 1990 to 2004 (APC: 10.3; 95% CI: 9.3, 11.3; P < 0.001), followed by a period of stability for 2004 to 2013 (APC: 1.3; 95% CI: -0.7, 3.3; P = 0.2), and then another significant increase for 2013 to 2017 (APC: 15.3; 95% CI: 8.7, 22.2; P < 0.001).Conclusions:Although prevalence has stabilized and incidence has declined, AIDS-related mortality has risen sharply in recent years. These findings suggest more must be done to bring people into treatment earlier, retain them in treatment more effectively, actively seek to reenter them in treatment if they dropout, and improve the quality of treatment and care regimens.

简介：AbstractBackground:Superficial temporal artery (STA)-middle cerebral artery (MCA) bypass surgery is now being widely used in moyamoya disease, and its therapeutic value in SICAO remains divergent.Methods:A systematic search was performed in PubMed, EMBASE, and Cochrane Databases in Feb. 2020 and updated in Jun. 2019. We have strict inclusion and exclusion criteria. Cochrane Bias Risk Assessment Tool was used to assess the quality of included RCTs. Review Manager 5.3 was used for analysis results in terms of comparing the STA-MCA bypass and BMT. For dichotomous variable outcomes, risk ratios (RRs) and 95% confidence intervals (95%CIs) were calculated for the assessment.Results:The total patient cohort consisted of 2419 patients, of whom 1188 (49.1%) patients had been grouped in STA-MCA bypass and 1231 (50.9%) patients had been divided into the BMT group. Mean follow-up of included patients was 29 months. The RR of the seven studies was 1.01, and the 95% confidence interval was .89-1.15, with statistical significance, Z = .13, P = .89, sustaining that STA-MCA bypass was not superior to BMT in symptomatic carotid artery occlusion disease.Conclusions:STA-MCA bypass and BMT were associated with similar rates of a composite of long-term stroke. And the risk of long-term overall stroke was mildly higher with BMT. At present, each patient should receive more precise treatment, by reasonably assessing the individual differences of each patient to reduce the recurrence rate of stroke.

简介：AbstractBackground:Coronary artery disease (CAD) is the commonest cause of heart failure (HF), whereas pulmonary hypertension (PH) has not been established or reported in this patient population. Therefore, we assessed the prevalence, risk factors, and survival in CAD-associated HF (CAD-HF) complicated with PH.Methods:Symptomatic CAD-HF patients were continuously enrolled in this prospective, multicenter registry study. Echocardiography, coronary arteriography, left and right heart catheterization (RHC), and other baseline clinical data were recorded. Patients were followed up and their survival was recorded.Results:One hundred and eighty-two CAD-HF patients were enrolled, including 142 with HF with a preserved ejection fraction (heart failure with preserved ejection fraction [HFpEF]; left ventricular ejection fraction [LVEF] ≥50%) and 40 with a reduced ejection fraction (heart failure with reduced ejection fraction [HFrEF]; LVEF < 50%). PH was diagnosed with RHC in 77.5% of patients. Patients with PH showed worse hemodynamic parameters and higher mortality. HFrEF-PH patients had worse survival than HFpEF-PH patients. CAD-HF patients with an enlarged left ventricular end-diastolic diameter and reduced hemoglobin were at higher risk of PH. Nitrate treatment reduced the risk of PH. Elevated creatinine and mean pulmonary arterial pressure (mPAP), diastolic pressure gradient (DPG) ≥7 mmHg, and previous myocardial infarction (MI) entailed a higher risk of mortality in CAD-HF patients with PH.Conclusions:PH is common in CAD-HF and worsens the hemodynamics and survival in these patients. Left ventricle enlargement and anemia increase the risk of PH in CAD-HF. Patients may benefit from nitrate medications. Renal impairment, elevated mPAP, DPG ≥7 mmHg, and previous MI are strong predictors of mortality in CAD-HF-PH patients.Trial Registration:ClinicalTrials.gov, NCT02164526.

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简介：AbstractBackground:Resting heart rate (RHR) is considered as a strong predictor of total mortality and hospitalization due to heart failure in hypertension patients. Bisoprolol fumarate, a second-generation beta-adrenoreceptor blockers (β-blocker) is commonly prescribed drug to manage hypertension. The present study was to retrospectively evaluate changes in the average RHR and its association with cardiovascular outcomes in bisoprolol-treated coronary artery disease (CAD) patients from the CAD treated with bisoprolol (BISO-CAD) study who had comorbid hypertension.Methods:We performed ad-hoc analysis for hypertension sub-group of the BISO-CAD study (n = 866), which was a phase IV, multination, multi-center, single-arm, observational study carried out from October 2011 to July 2015 across China, South Korea, and Vietnam. Multivariate regression analysis was used to identify factors associated with incidence of composite cardiac clinical outcome (CCCO), the results were presented as adjusted odds ratio (OR) along with 95% confidence interval (CI) and adjusted P value.Results:A total of 681 patients (mean age: 64.77 ± 10.33 years) with hypertension from BISO-CAD study were included in the analysis. Bisoprolol improved CCCOs in CAD patients with comorbid hypertension, with RHR <65 and <70 beats/min compared with RHR ≥65 and ≥75 beats/min, respectively, in the efficacy analysis (EA) set. In addition, it lowered RHR in both intent-to-treat (ITT) and EA groups after 6, 12, and 18 months of treatment. Further, RHR 70 to 74 beats/min resulted in significantly higher risk of CCCOs EA set of patients (adjusted OR: 4.34; 95% CI: 1.19-15.89; P = 0.03). Also, events of hospitalization due to acute coronary syndrome were higher when RHR 69 to 74 beats/min compared to RHR <69 beats/min in ITT patients.Conclusion:Bisoprolol can effectively reduce RHR in Asian CAD patients with comorbid hypertension and hence, improve CCCO without affecting their blood pressure.

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简介：AbstractBackground:The platelet to lymphocyte ratio (PLR) has recently emerged as a potential inflammatory biomarker and has been shown to be significantly associated with atherosclerotic coronary artery disease (CAD). Therefore, we aimed to explore the association of PLR with in-hospital major adverse cardiovascular events (MACEs) and the severity of CAD assessed by the Gensini score (GS) in patients with acute myocardial infarction (AMI) undergoing coronary angiography.Methods:A total of 502 patients with AMI consecutively treated at the Affiliated Hospital of Qingdao University (Qingdao, China) and underwent coronary angiography from August 2017 to December 2018 were recruited in this study. The demographic, clinical, angiographic characteristics, and laboratory parameters were collected. According to the presence of in-hospital MACEs, the included patients were divided into the MACE group (n = 81) and the non-MACE group (n = 421). Further, according to tertiles of the GS, the patients were classified into three groups: the low GS group (GS ≤32 points, n = 173), medium GS group (32 points < GS ≤ 60 points, n = 169), and high GS group (60 points < GS ≤ 180 points, n = 160). The main statistical methods included Chisquared test, non-parametric Mann-Whitney U test, Kruskal-Wallis H test, logistic regression, and receiver operating characteristic curves.Results:The PLR in the MACE group was significantly higher than that in the non-MACE group (179.43 [132.84, 239.74] vs. 116.11 [87.98, 145.45], Z = -8.109, P < 0.001). Further, there were significant differences in PLR among the tertiles of GS (110.05[84.57, 139.06] vs. 119.78 [98.44, 157.98] vs. 140.00 [102.27, 191.83], H= 19.524, P < 0.001). PLR was demonstrated to be an independent risk factor of in-hospital MACEs (odds ratio [OR]: 1.012, 95% confidential interval [CI]: 1.006-1.018, P < 0.001) and severe CAD assessed by the GS (OR: 1.004, 95% CI: 1.002-1.009, P= 0.042). The cutoff value of PLR for predicting the development of in-hospital MACEs was 151.28 with a sensitivity of 66.7% and a specificity of 78.1% (area under the curve [AUC]: 0.786, 95% CI: 0.730-0.842, P < 0.001), and a PLR of 139.31 was also identified to be an effective cutoff point for detecting a high GS (<60 points) with a sensitivity of 49.4% and a specificity of 69.6% (AUC: 0.611, 95% CI: 0.556-0.666, P < 0.001).Conclusions:PLR as a novel inflammatory marker is significantly and independently associated with the occurrence of in-hospital MACEs and the severity of CAD assessed by the GS in patients with AMI. As an easily available and inexpensive inflammatory indicator, PLR could be widely used as an efficient inflammatory biomarker for identifying high-risk patients and for individualizing targeted therapy to improve the prognosis of AMI.

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简介：AbstractBackground:Diagnoses of Skin diseases are frequently delayed in China due to lack of dermatologists. A deep learning-based diagnosis supporting system can facilitate pre-screening patients to prioritize dermatologists’ efforts. We aimed to evaluate the classification sensitivity and specificity of deep learning models to classify skin tumors and psoriasis for Chinese population with a modest number of dermoscopic images.Methods:We developed a convolutional neural network (CNN) based on two datasets from a consecutive series of patients who underwent the dermoscopy in the clinic of the Department of Dermatology, Peking Union Medical College Hospital, between 2016 and 2018, prospectively. In order to evaluate the feasibility of the algorithm, we used two datasets. Dataset I consisted of 7192 dermoscopic images for a multi-class model to differentiate three most common skin tumors and other diseases. Dataset II consisted of 3115 dermoscopic images for a two-class model to classify psoriasis from other inflammatory diseases. We compared the performance of CNN with 164 dermatologists in a reader study with 130 dermoscopic images. The experts’ consensus was used as the reference standard except for the cases of basal cell carcinoma (BCC), which were all confirmed by histopathology.Results:The accuracies of multi-class and two-class models were 81.49% ± 0.88% and 77.02% ± 1.81%, respectively. In the reader study, for the multi-class tasks, the diagnosis sensitivity and specificity of 164 dermatologists were 0.770 and 0.962 for BCC, 0.807 and 0.897 for melanocytic nevus, 0.624 and 0.976 for seborrheic keratosis, 0.939 and 0.875 for the "others" group, respectively; the diagnosis sensitivity and specificity of multi-class CNN were 0.800 and 1.000 for BCC, 0.800 and 0.840 for melanocytic nevus, 0.850 and 0.940 for seborrheic keratosis, 0.750 and 0.940 for the "others" group, respectively. For the two-class tasks, the sensitivity and specificity of dermatologists and CNN for classifying psoriasis were 0.872 and 0.838, 1.000 and 0.605, respectively. Both the dermatologists and CNN achieved at least moderate consistency with the reference standard, and there was no significant difference in Kappa coefficients between them (P > 0.05).Conclusions:The performance of CNN developed with relatively modest number of dermoscopic images of skin tumors and psoriasis for Chinese population is comparable with 164 dermatologists. These two models could be used for screening in patients suspected with skin tumors and psoriasis respectively in primary care hospital.

简介：AbstractBackground:The risk for chronic kidney disease (CKD) is influenced by genetic predisposition, sex, and lifestyle. Previous research indicates that coffee is a potentially protective factor in CKD. The current study aims to investigate whether sex disparity exists in the coffee–CKD association, and whether genetic risk of CKD or genetic polymorphisms of caffeine metabolism affect this association.Methods:A total of 359,906 participants from the UK Biobank who were enrolled between 2006 and 2010 were included in this prospective cohort study, which aimed to estimate the hazard ratios for coffee intake and incident CKD using a Cox proportional hazard model. Allele scores of CKD and caffeine metabolism were additionally adjusted for in a subsample with qualified genetic data (n = 255,343). Analyses stratified by genetic predisposition, comorbidities, and sex hormones were performed. Tests based on Bayesian model averaging were conducted to ascertain the robustness of the results.Results:Coffee was inversely associated with CKD in a dose-dependent manner. The effects of coffee did not differ across different strata of genetic risk for CKD, but were more evident among slower genetically predicted caffeine metabolizers. Significant sex disparity was observed (P value for interaction = 0.013), in that coffee drinking was only associated with the risk reduction of CKD in females. Subgroup analysis revealed that testosterone and sex hormone-binding globulin (SHBG), but not estradiol, modified the coffee–CKD association.Conclusions:In addition to the overall inverse coffee–CKD association that was observed in the general population, we could also establish that a sex disparity existed, in that females were more likely to experience the benefit of the association. Testosterone and SHBG may partly account for the sex disparity.

简介：AbstractBackground:Non-transport unintentional injuries (NTUIs) are major public concerns, especially among children and adolescents in low- and middle-income countries. With environmental and cognitive changes, a recent systematic description of global trends and regional differences concerning NTUIs is urgently needed for the global agenda of relevant policy-making and intervention target findings.Methods:We used mortality, population, and socio-demographic-index (SDI) data from Global Burden of Disease 2019 to analyze the trends of NTUIs mortality. We applied the slope index of inequality (SII) and relative index of inequality (RII) to measure the absolute and relative inequality between countries and territories. The concentration curve and concentration index (CI) were also used to measure the inequality. We conducted a sensitivity analysis to make our findings credible.Results:In 2019, there were 205,000 deaths due to NTUIs among children and adolescents aged 5 to 24 years, which decreased from 375,000 in 1990. In 2019, the age-standardized mortality rate (ASMR) was 8.13 per 100,000, ranging from the lowest in the Netherlands (0.90 per 100,000) to the highest in the Solomon Islands (29.34 per 100,000). The low-middle SDI group had the highest ASMR of NTUIs, while the low SDI group had the slowest decrease. After excluding the death caused by "exposure to forces of nature" and "other unintentional injuries" , drowning accounted for the most deaths in almost every SDI group, gender, and age group, but the major causes of death varied in different subgroups. For example, animal contact was a major cause in low and low-middle SDI groups but less in high SDI groups, while high and high-middle SDI groups had a higher proportion of deaths for foreign body and poisonings. The SII showed a declining trend, but the RII and CI did not, which might indicate that inequality was persistent. Similar results were found in the sensitivity analysis.Conclusions:Despite the declining trend of the mortality rate and the narrowing gap between countries, there were still a large number of children and adolescents dying from NTUIs, and those experiencing social-economic disadvantages remained at high mortality. Embedding the prevention of NTUIs into sustainable development goals might contribute to the progress of reducing death and inequalities, which ensures that no one is left behind.

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简介：AbstractBackground:The Shexiang Baoxin Pill (MUSKARDIA) has been used for treating coronary artery disease (CAD) and angina for more than 30 years in China. Nevertheless, methodologically sound trials on the use of MUSKARDIA in CAD patients are scarce. The aim of the study is to determine the effects of MUSKARDIA as an add-on to optimal medical therapy (OMT) in patients with stable CAD.Methods:A total of 2674 participants with stable CAD from 97 hospitals in China were randomized 1:1 to a MUSKARDIA or placebo group for 24 months. Both groups received OMT according to local tertiary hospital protocols. The primary outcome was the occurrence of a major adverse cardiovascular event (MACE), defined as a composite of cardiovascular death, non-fatal myocardial infarction (MI), or non-fatal stroke. Secondary outcomes included all-cause mortality, non-fatal MI, non-fatal stroke, hospitalization for unstable angina or heart failure, peripheral revascularization, angina stability and angina frequency.Results:In all, 99.7% of the patients were treated with aspirin and 93.0% with statin. After 2 years of treatment, the occurrence of MACEs was reduced by 26.9% in the MUSKARDIA group (MUSKARDIA: 1.9% vs. placebo: 2.6%; odds ratio = 0.80; 95% confidence interval: 0.45-1.07; P = 0.2869). Angina frequency was significantly reduced in the MUSKARDIA group at 18 months (P = 0.0362). Other secondary endpoints were similar between the two groups. The rates of adverse events were also similar between the two groups (MUSKARDIA: 17.7% vs. placebo: 17.4%, P = 0.8785).Conclusions:As an add-on to OMT, MUSKARDIA is safe and significantly reduces angina frequency in patients with stable CAD. Moreover, the use of MUSKARDIA is associated with a trend toward reduced MACEs in patients with stable CAD. The results suggest that MUSKARDIA can be used to manage patients with CAD.Trial registration:chictr.org.cn, No. ChiCTR-TRC-12003513

简介：BackgroundItiswellknownthattherewasasignificantlinkbetweenpreproceduralbloodglucoselevelsandshort-termandlong-termadverseoutcomesinpatientsundergoingelectivePCI.However,theroleofpre-proceduralbloodglucoselevelsasapredictorofadverseeventsinCKDpatientswhounderwentPCIoutofestablisheddiabeteshasyettobeidentified.MethodsInourstudy,weconductedaprospectivestudyof331acutecoronarysyndrome(ACS)patientswithCKDwhounderwentPCIoutofestablisheddiabetes.Patientsweredividedintotwogroupsbasedonpre-proceduralglucoselevels(hypoglycemia<7.0mmol/L;hyperglycemia≥7.0mmol/L).Allpatientswerefollowedupprospectivelyformajoradversecardiovascularevents(MACEs)andmortalityfor6months.ResultsInourcohort,hyperglycemiapatientsreportedahigherincidenceofin-hospitalmortalitythanhypoglycemiapatients(7.5%vs.0%,P<0.001).Hyperglycemiapatientsreportedasignificantlyhigherrateof6-monthMACEs(10%vs.2.4%,P=0.007),allcausemortality(7.5%vs.1.6%,P=0.015),andcardiovascularmortality(6.2%vs1.6%,P=0.041)comparedwithhypoglycemiapatientswithpre-proceduralglucoselevels<7.0mmol/L.Multivariateanalysisdisclosedthatapre-proceduralglucoselevel≥7.0mmol/LwasasignificantindependentpredictorofMACEs(OR=2.53,95%CI1.68-17.15,P=0.004),allcausemortality(OR=4.6,95%CI1.10-18.84,P=0.036),andcardiovascularmortality(OR=6.2,95%CI1.53-24.94,P=0.011)at6monthsinpatientsafterPCI.ConclusionThestudysuggestedthatpre-proceduralglucoselevelsareassociatedwithshort-termcardiovascularoutcomeCKDpatientswhounderwentPCIwithoutestablisheddiabetesinthesettingofACS.

简介：Toinvestigatetheroleofnegative-regulatoryfactorsA20,IRF-4andTRAF4ofthetoll-likereceptor(TLR)signalpathwaysinimmunologicalpathogenesisofKawasakidisease(KD),48childrenwithKawasakidisease,16childrenwithinfectiousdisease(ID)and16age-matchedhealthychildrenwerestudied.Reverse-transcriptionPCR(RT-PCR)andreal-timePCRwereusedtoevaluatetheexpres-sionlevelsofnegative-regulatoryandeffectivefactorsintoll-likereceptor4(TLR4)signalpathwaysandproinflammatoryfactorsinperipheralbloodmonocyte/macrophage(MC).Inthisstudy,expressionlevelsofTLR4,MD-2,MyD88,IRAK-4,TRAF6,TAK1,andTAB2mRNAinKDgroupweredetectedtobeelevatedsignificantlyduringacutephaseofKD.Transcriptionlevelsofnegative-regulatoryfactorsA20,IRF-4andTRAF4mRNAinKDorIDpatientsincreasedremarkably.However,expressionsofIRF-4andTRAF4inKDpatientsweredetectedtobelowerthanthatinIDpatients,exceptthattran-scriptionlevelsofA20werefoundtobehigherthanthatinIDpatients.Simultaneously,expressionsofproinflammatorycytokinessuchasL-1β,IL-6andTNF-αinKDpatientsweresignificantlyelevatedcom-paredwiththoseinIDpatients.Furthermore,itwasfoundthatstimulationoflipopolysaccharide(LPS)remarkablyup-regulatedtheexpressionsofnegative-regulatoryfactorsA20,IRF-4andTRAF4inKDpa-tientsorhealthyvolunteers.ThemRNAlevelsofallthethreefactorsinKDpatientswerefoundtobelowerthanthatinthelatter.Inaddition,transcriptionlevelsofIRF-4andTRAF4inKDpatientswithcoronaryarterylesion(KD-CAL~+)weredetectedtobelowerthanthoseinKDpatientswithoutcoronaryarterylesion(KD-CAL~-)duringacutephase,whilethatofA20inKD-CAL~+groupwerelowerthanthatinthelatter.AndthelevelsofexpressionsofproinflammatorycytokinesinKD-CAL~+groupwerefoundtobehigherthanthoseinKD-CAL-group(P<0.01).Thesefindingssuggestthataberrantexpressionofnegative-regulatoryfactorsofTLRssignalpathwaysmaybeinvolved

简介：摘要：目的 了解巴州2015-2020年手足口病病原学流行趋势和特征，为手足口防控措施提出科学依据，快速有效应对突发公共卫生事件。 方法 对巴州2015-2020年手足口病病原学监测结果进行统计分析。 结果 2015-2020年巴州共采集手足口病标本895份，其中阳性614份，检测阳性率68.91%（614/891）。其中，EV71 68例（11.07%），CA16 220例（35.83%），CA6 207例（33.71%），CA10 19例（3.10%），其他100例（16.29%）；CA16和CA6轮流占主导地位，自2016年开始CA6逐渐成为致病优势基因型，2016年占比42.86%，2017年占比25.19%，2018年占比32.79%，2019年占比59.23%，2020年占比60.00%；2015—2020年巴州共报告病例数1905例，发病年龄主要集中在0—6岁，1岁至4岁为发病高峰；无死亡病例，无重症病例。 结论 巴州手足口病的流行型别已由EV71、CA16转变为CA6为主，CA16为辅，应加强对CA6、CA10的监测预警，在EV71手足口病疫苗的基础上，研发包括CA6、CA16型别在内的多价疫苗进行预防性接种。

简介：【摘要】 目的 分析网络多学科团队(eMDT)联合精准化护理模式在新冠肺炎（coronavirus disease 2019）中的护理效果。方法 于2021年3月-2022年4月开展研究，将本院收治的70例新冠肺炎患者以随机抽签法分组，各35例，对照组实施常规护理，观察组实施eMDT联合精准化护理。对比护理效果。结果 观察组干预优良率高于对照组（P

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简介：AbstractBackground: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).