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BACKGROUNDIn-depth investigations of the safety and immunogenicity of inactivated SARS-CoV-2 vaccines are needed. METHODIn a phase I randomized, double-blinded, and placebo-controlled trial involving 192 healthy adults 18-59 years of age, two injections of three different doses (50 EU, 100 EU and 150 EU) of an inactivated SARS-CoV-2 vaccine or the placebo were administered intramuscularly with a 2- or 4-week interval between the injections. The safety and immunogenicity of the vaccine were evaluated within 28 days. FINDINGIn this study, 191 subjects assigned to three doses groups or the placebo group completed the 28-day trial. There were 44 adverse reactions within the 28 days, most commonly mild pain and redness at the injection site or slight fatigue, and no abnormal variations were observed in 48 cytokines in the serum samples of immunized subjects. The serum samples diluted from 1:32 to 1:4096 and incubated with the virus did not show antibody-dependent enhancement effects (ADEs) with regard to human natural killer cells, macrophages or dendritic cells. At day 14, the seroconversion rates had reached 92%, 100% and 96% with geometric mean titers (GMTs) of 18.0, 54.5 and 37.1, and at day 28, the seroconversion rates had reached 80%, 96% and 92% with GMTs of 10.6, 15.4 and 19.6in 0, 14 and 0, 28 procedures, respectively. Seroconversion was associated with the synchronous upregulation of ELISA antibodies against the S protein, N protein and virion and a cytotoxic T lymphocyte (CTL) response. Transcriptome analysis shaped the genetic diversity of immune response induced by the vaccine. INTERPRETATIONIn a population aged 18-59 years, this inactivated SARS-CoV-2 vaccine was safe and immunogenic. Trial registrationNCT04412538 FUNDINGThe National Key R&D Program of China (2020YFC0849700), the Program of Chinese Academy of Medicine Science and the Major Science and Technology Special Projects of Yunnan Province.
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With the relatively serious global epidemic outbreak of SARS-CoV-2 infection, public concerns focus on not only clinical therapeutic measures and public quarantine for this disease but also the development of vaccines. The technical design of our SARS-CoV-2 inactivated vaccine provides a viral antigen that enables the exposure of more than one structural protein based upon the antibody composition of COVID-19 patients convalescent serum. This design led to valid immunity with increasing neutralizing antibody titers and a CTL response detected post-immunization of this vaccine by two injections in rhesus macaques. Further, this elicited immunoprotection in macaques enables not only to restrain completely viral replication in tissues of immunized animals, compared to the adjuvant control and those immunized by an RBD peptide vaccine, but also to significantly alleviate inflammatory lesion in lung tissues in histo-pathologic detection, compared to the adjuvant control with developed interstitial pneumonia. The data obtained from these macaques immunized with the inactivated vaccine or RBD peptide vaccine suggest that immunity with a clinically protective effect against SARS-CoV-2 infection should include not only specific neutralizing antibodies but also specific CTL responses against at least the S and N antigens.
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Objective@#To analyze the association between the self-rated health (SRH) status and risk of cardiovascular disease (CVD) among the middle-aged and eldly Chinese.@*Methods@#Data were obtained from the China Health and Retirement Longitudinal Study (CHARLS), which enrolled 21 133 participants by using the probability proportional to size (PPS) sampling from 150 counties/districts of 28 provinces in China from 2011 to 2012. A total of 11 701 participants were included in the study. Basic information and SRH were obtained in the baseline survey via questionnaires. Information of CVD was self-reported during the follow-up. Cox proportional hazards modeling was used to analyze the association between the baseline SRH and risk of CVD. Subgroup analyses were performed by age, sex and body mass index (BMI), and their interactions with SRH for risk of CVD were examined by using the likelihood ratio test. A sensitivity analysis was conducted to test the robustness of the association.@*Results@#Participants were (57.9±9.7) years old, and men accounted for 48.1% (5 626). SRH was reported as the excellent, very good, good, fair and poor among 4.2% (n=487), 13.5% (n=1 583), 33.6% (n=3 932), 35.4% (n=4 147) and 13.3% (n=1 552), respectively. During 42 104 person-years of followed up, 590 cases of CVD were identified. Cox regression analyses showed that compared with the excellent/very good SRH, the HR (95%CI) of CVD risk for the good, fair and poor SRH was 1.36 (1.02-1.80), 1.66 (1.26-2.19) and 1.89 (1.38-2.59), respectively. Subgroup analyses showed that compared with the excellent/very good SRH, HR (95%CI) of CVD risk for poor SRH in the group of 45-59 years old, equal to or over 75 years old, men, women and normal BMI were 2.00 (1.32-3.04), 3.87 (1.04-14.46), 1.76 (1.07-2.91), 1.92 (1.27-2.91) and 2.30 (1.42-3.72), respectively. There were no interactions between age, sex, BMI and SRH (P>0.05).@*Conclusion@#SRH is associated with risk of CVD among middle-aged and elderly Chinese. The CVD risk for good, fair and poor SRH is higher than that for excellent/very good SRH.
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Objective To provide references for future government science and technology plan on providing projects for the research and development of new vaccine products.Methods Through analyzing various vaccines that have gained projects from government science and technology plan,this paper summarizes types of science and technology projects,funding proportion and characteristics of science and technology projects at national,provincial and municipal level for vaccine at different research and development stages.Results In general,the supporting categories and levels of projects at different levels are clear.Each research and development stage of new vaccine products has corresponding science and technology planning projects,which are closely linked with each other.Conclusions The government's science and technology funding plays an important role in guiding and promoting the research and development of new vaccine products.
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Objective@#To compare the safety and immunogenicity of two different sequential schedules of inactivated poliomyelitis vaccine made from Sabin strain (sIPV) followed by typeⅠ+Ⅲ bivalent oral poliovirus vaccine (bOPV) in Drug Candy (DC) form or liquid dosage form).@*Methods@#This randomized, blinded, single center, parallel-group controlled trial was done from September 2015 to June 2016 in Liuzhou, Guangxi province. Healthy infants aged ≥2 months were eligible for enrollment and divided into 1sIPV+2bOPV or 2sIPV+1bOPV sequential schedules. According to the bOPV dosage form each sequential schedules, the subjects again were divided into drug candy(DC) form or liquid dosage form group, being 1sIPV+bOPV (DC)/1sIPV+2bOPV(liquid)/2sIPV+1bOPV(DC)/2sIPV+1bOPV(liquid). According to 0, 28, 56 d immunization schedule, Each group were given 3 doses. We recorded adverse events during the clinical trial (399 participants who receive at least one dose). 28 days post-Dose 3, we receive a total of 350 blood samples (excluding the quitters or subjects against trial plan), using cell culture trace against polio virus neutralization test Ⅰ, Ⅱ, Ⅲ neutralizing antibody (GMT), calculating the antibody positive rate.PolioⅠ,Ⅱand Ⅲ antibody titers were assessed by virus-neutralizing antibody assay and the seroconversion (4-fold increase in titer) from pre-Dose 1 to 28 days post-Dose 3 was calculated (total 350 samples) .@*Results@#During the vaccination, the incidence of AEs in 1sIPV+2bOPV(DC), 1sIPV+2bOPV (liquid), 2sIPV+1bOPV(DC), 2sIPV+1bOPV (liquid) group were 79%, 76%, 80% and 74% (χ2=1.23, P=0.747) , respectively. The severe AEs in groups were 6%, 5%, 6% and 4% (χ2=0.57, P=0.903) , respectively, and none was considered to be vaccination related. 28 days after 3rd vaccination, the seroconversion rates in 1sIPV+2bOPV (DC), 1sIPV+2bOPV (liquid), 2sIPV+1bOPV (DC), 2sIPV+1bOPV (liquid) group, were 99%, 100%, 99% and 99% (χ2=0.94, P=0.815) , respectively, for type Ⅰ poliovirus; and 47%, 57%, 80%, 79% (χ2=31.56, P<0.001) , respectively, for type Ⅱ; and were 100%, 99%, 100%, 99% (χ2=2.02, P=0.568) , respectively, for type Ⅲ. In each group, the GMT of antibody against poliovirus typeⅠ were 4 539.68, 6 243.43, 6 819.53 and 7 916.29 (F=25.87, P<0.001) , respectively; Type Ⅱ were 12.98, 10.54, 63.75 and 84.21 (F=8.68, P=0.034) , respectively; Type Ⅲ were 1 172.55, 1 416.03, 2 648.89 and 3 250.75 (F=14.50, P=0.002) , respectively.@*Conclusion@#On the same sequential schedules, there was no significant difference between the dosage forms, all of them showed good safety and immunogenicity. In the same dosage forms with different sequential schedules, the seroconversion rate was higher in 2 dose sIPV group than the 1 dose sIPV group, especially at the neutralizing antibody GMT level against polio type Ⅱ and Ⅲ after vaccination.
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Curcumae Rhizoma comes from Curcuma genus,functional breaking blood stasis,detumescence and acesodyne for treatment of Zhengjia accumulation,amenorrhea,traumatic injury and bruising pain.Modem pharmacological studies have shown that the main monomer composition of zedoary turmeric has a good anti-inflammatory and anti-tumor effects.The main monomer composition of zedoary turmeric copies of curcumol,beta etemene,curcumin anti-inflammatory anti-tumor mechanism of review,provide the basis for the further research progress and clinical application of zedoary turmeric.
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Objective To investigate the dynamic changes of three types of anti-poliovirus neutralizing antibodies and anti-hepatitis A virus (HAV) IgG antibody in children who were immunized with inactivated enterovirus 71 (EV71) vaccine (human diploid cell).Methods Serum samples were collected from the subjects immunized with inactivated EV71 vaccine.Neutralizing antibodies against EV71 and poliovirus were detected by micro-cytopathic effect neutralization test.Enzyme linked immunosorbent assay (ELISA) was used to detect IgG antibody against HAV.Results The geometric mean titers (GMTs) of anti-EV71 neutralizing antibody increased to 4.85 following the first-dose injection of inactivated EV71 vaccine.A significant increase of GMTs (up to 64.37) could be observed 28 days after the second-dose vaccination.Meanwhile, results of the dynamic monitor showed that there were slight fluctuations in the neutralizing antibodies against three types of poliovirus on day 28 (28 days after the first-dose vaccination) compared with those on day 0 (before vaccination) (P0.05).The level of anti-HAV IgG antibody was stable and no significant difference was found during the observation period (P>0.05).Conclusion This study shows that inactivated EV71 vaccine has no impact on anti-HAV IgG antibody in Children during the two-dose vaccination and in anti-EV71 antibody-producing period, but has slight influence on the anti-poliovirus antibodies.In general, changes in antibody profile do not affect the clinical efficacy of immune response.
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Objective To investigate the effects of two sputum aspirations on old critical patients.Methods Sixty elderly critical patients were divided into the experiment group and control group in equal number.The former group received sputum aspiration by oropharynx airpipe and the control group by oronasal airpipe.The two groups were compared in terms of sputum aspiration effect and saturation of blood oxygen.Result The observation group was significantly better than the control group in terms of sputum aspiration effect and saturation of blood oxygen(both P<0.05).Conclusion Sputum aspiration by oropharynx airpipe is effective in the aspiration of secretions from respiratory tract and the reduced effect of saturation of blood oxygen.
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Objective To study the influence of walking exercise training on heart function, left heart ventricle structure and plasma brain natriuretie peptide (BNP) concentration in patients with chronic heart failure ( CHF), to explore the sense of exercise training.Methods A total of 223 CHF patients were randomly assigned to a guided rehabilitation group, a non-guided rehabilitation group and a control group.All patients were given basic medicine treatment, and the guided rehabilitation group was administered guided walking exercise training program, while the non-guided rehabilitation group was encouraged to do exercise freely but with no guidance.Blood pressure, 6 min walking distance test, plasma concentration of BNP and echocardiography were measured in all patients before and after exercise training.Results At entry to the study, there was no significant difference among the 3 groups with regard to blood pressure, 6 rain walking distance and BNP level as well as echocardiographic parameters including left ventrieular ejection fraction (LVEF) and left ventricular end-diastolic diameter (LVEDd).A follow-up at the 6th month after intervention, the amount of readmission patients in guided rehabilitation group were significantly less than those in non-guided rehabilitation and control groups ( P < 0.05 ).It was also revealed that the plasma concentration of BNP decreased significantly ( P < 0.01 ) ; LVEF and 6 min walking distance improved significantly ( P < 0.01 ) in the guided rehabilitation group when compared with baseline and 6-month follow-up of the non-guided rehabilitation and control groups.However, there observed no significant change with regard to LVEDd.Conclusion Walking exercise training can improve exercise endurance in CHF patients and is safety; but has no influence on left heart ventricular structure in short time.