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@#Objective To analyze the safety of children of different ages vaccinated with measles,mumps and rubella combined attenuated live vaccine(MMR in brief)/measles and rubella combined attenuated live vaccine(MR in brief)in Jilin Province from 2015 to 2022.Methods The actual vaccination data of MMR and MR from January 1,2015 to December 31,2022 were collected through the Jilin information management system for immunization programming,and all AEFI case information reported after vaccination with MMR and MR in this period was collected through the national adverse event following immunization(AEFI) monitoring and reporting system.The incidence rates of AEFI reports were compared among8-month-old children vaccinated with the first dose of MMR(MMR 8 group) and MR(MR8 group),18-month-old children vaccinated with the first dose of MMR(vaccinated with MR at 8 months old,MMR18-1 group) and the second dose of MMR(vaccinated with the first dose of MMR at 8 months old,MMR18-2 group) to preliminarily evaluate the safety of children vaccinated with MMR and MR at different ages.Results The reported incidence of AEFI in MMR8,MR8,MMR18-1 and MMR18-2 groups were 374.41/100 000,350.81/100 000,101.70/100 000 and 104.91/100 000,respectively,with significant difference among the four groups(χ~2=1 145.47,P=0.00);There was no significant difference between MMR8 and MR8,as well as MMR18-1 and MMR18-2 groups(χ~2=3.780 and 0.194,respectively,each P> 0.05);There were significant differences between MMR8 and MMR18-1,MMR8 and MMR18-2,as well as MR8 and MMR18-1groups(χ~2=920.440,412.110 and 1 021.120,respectively,each P=0.00).Most of the adverse reactions were general reactions,mainly fever,local redness and induration;A few were abnormal reactions,which were mainly allergic reactions(rash,papules,urticaria,etc.).Only one case of coincidence was reported in MMR8 group,and no psychogenic reaction,vaccine quality accident and vaccination accident occurred.All AEFI turned out to be improved or cured.Conclusion The differences of AEFI reported incidence of 8-month-old children vaccinated with MMR and MR were all small,and the difference of AEFI reported incidence of 18-month-old children vaccinated with the second dose of MMR was small regardless of the initial vaccination with MMR or MR.It is safe to use MMR instead of MR for the first vaccination in8-month-old children.
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@#Human respiratory syncytial virus(hRSV)is one of the main pathogens that cause lower respiratory tract infection in infants and the elderly.hRSV genome contains 10 genes with a full length of 15 222 bp,encoding 11 proteins(9structural proteins and 2 non-structural proteins).Different proteins play different roles in the pathogenesis of hRSV.With the in-depth research on the biological and structural characteristics of hRSV,various types of hRSV vaccines have been developed,making rapid progress.For example,hRSV attenuated live vaccine hRSV ?NS2/?1313/I1314L has entered Phase II clinical trial,and hRSV subunit protein vaccine Pre-F-GCN4t has entered Phase III clinical trial.In this paper,the biological characteristics of hRSV and the types of hRSV vaccines with rapid progress are reviewed so as to provide a reference for the development of hRSV vaccines in China.
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ObjectiveTo evaluate the dosage effect of measles， mumps and rubella combined attenuated live vaccine （MMR） vaccination on seroprevalence of mumps. MethodsA cross-sectional study was conducted among people in Changning District of Shanghai aged 1 month to 19 years old （n=1 816） in Mar.－Sep. 2017. Blood samples were analyzed for mumps antibodies using enzyme-linked immunosorbent immunoglobulin G （IgG） assays. ResultsMumps antibody seropositivity was 94.59% in 2 years old children and maintained at 98.18%-100.00% from 4 to 9 years old. The seropositivity began to decrease since 10 years， and it was 88.33% （95%CI： 81.20%-93.47%） at age of 12 years. In 12-19 years age group， individuals with 3 doses of mumps-containing vaccines had the highest seropositivity （93.88%） and individuals with 1 or 0 doses had the lowest seropositivity （68.75%）. ConclusionTwo-dose MMR immunization in Shanghai induces a sharp increase in mumps antibody levels in the corresponding age groups. The antibody levels decline gradually with time since the second dose. Vaccine dosage is positively associated with mumps IgG seropositivity and geometric mean concentrations （GMC） in 12-19 years old.
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ObjectiveTo evaluate the dosage effect of measles， mumps and rubella combined attenuated live vaccine （MMR） vaccination on seroprevalence of mumps. MethodsA cross-sectional study was conducted among people in Changning District of Shanghai aged 1 month to 19 years old （n=1 816） in Mar.－Sep. 2017. Blood samples were analyzed for mumps antibodies using enzyme-linked immunosorbent immunoglobulin G （IgG） assays. ResultsMumps antibody seropositivity was 94.59% in 2 years old children and maintained at 98.18%-100.00% from 4 to 9 years old. The seropositivity began to decrease since 10 years， and it was 88.33% （95%CI： 81.20%-93.47%） at age of 12 years. In 12-19 years age group， individuals with 3 doses of mumps-containing vaccines had the highest seropositivity （93.88%） and individuals with 1 or 0 doses had the lowest seropositivity （68.75%）. ConclusionTwo-dose MMR immunization in Shanghai induces a sharp increase in mumps antibody levels in the corresponding age groups. The antibody levels decline gradually with time since the second dose. Vaccine dosage is positively associated with mumps IgG seropositivity and geometric mean concentrations （GMC） in 12-19 years old.
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Objective@#To analyze the surveillance of adverse event following immunization (AEFI) among 8-month-old children in Jiaxing who received measles, mumps and rubella combined attenuated live vaccine (MMR) or measles and rubella combined attenuated live vaccine (MR) , so as to provide support for the adjustment of vaccine immunization strategy.@*Methods @#The AEFI information of MR (December 1, 2016 to April 30, 2018) and MMR (December 1, 2018 to April 30, 2020) was collected through National AEFI Monitoring Information Management System to compare the incidence, clinical features, occurred time of AEFI as well as combined vaccination.@*Results@#Totally 94 287 doses of MR and 79 994 doses of MMR were administered, 145 and 156 cases of AEFI were reported, and the incidence rate was 15.38/10 000 after MR vaccination, which was lower than 19.50/10 000 after MMR vaccination (P<0.05). Most reported AEFI were abnormal reactions, with 93 cases (11.63/10 000) after MR vaccination and 101 cases (10.71/10 000) after MMR vaccination, among which 72 cases (7.64/10 000) and 76 cases (9.50/10 000) respectively had allergic rash. The AEFI cases mainly occurred less than one day after vaccination, with 113 cases (77.93%) after MR vaccination and 125 cases (80.13%) after MMR vaccination. Most cases of AEFI were vaccinated with Japanese encephalitis attenuated live vaccine (JEV), with 103 cases (71.03%) after MR vaccination and 102 cases (65.38%) after MMR vaccination.@*Conclusions@#The MMR is safety for 8-month-old children in Jiaxing. Most AEFI cases had abnormal reactions, occur within one day after vaccination, and are vaccinated with JEV.
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As the COVID-19 pandemic is intensifying globally, more and more people are pinning their hopes on the development of vaccines. At present, there are many research teams who have adopted different vaccine technology routes to develop 2019-nCoV vaccines. This article reviews and analyzes the current development and research status of 2019-nCoV vaccines in different routes, and explores their possible development in the future.
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Humans , Betacoronavirus , Coronavirus Infections , Pandemics , Pneumonia, Viral , Viral Vaccines , Therapeutic UsesABSTRACT
Objective To analyze the loss coefficient of bivalent live attenuated oral polio vaccine（bOPV) in Hongshan District, and understand the causes and influencing factors, and to provide a basis for scientifically formulating vaccine use plans and regulating vaccine management. Methods Using the data of Hubei Province Immunization Planning Information System and Hongshan District Vaccination Storage and Management System, a special questionnaire was designed to understand the vaccination and use of bOPV in various immunization units in Hongshan District. A descriptive statistical analysis method was used to calculate the loss coefficient. Results The bOPV loss coefficient of 25 vaccination units in Hongshan District was 1.69. The difference of the loss coefficient between the out-patient clinics of the District Health and Family Planning Committee（1.35）and the community clinics undertaken by large hospitals (2.01）was statistically significant. The difference of the loss coefficient between the inoculation once a week（1.57）and 2-6 times per week（1.94）was statistically significant. In terms of vaccine-disabled time, the two groups of 4 hours had different calculated loss coefficients 1.86 and 1.61, respectively, and the difference was statistically significant. Multivariate regression analysis of the factors related to the loss coefficients found that different outpatient attributes had a greater impact on the loss coefficient than the inoculation cycle and the number of inoculation stations. The loss coefficient for 2016 and 2017 was 2.09 and 1.75, respectively. The difference was statistically significant. Conclusion The management and use of live attenuated bivalent polio vaccine in Hongshan District was relatively standardized. The vaccine loss can by further reduced by strengthening supervision and assessment, setting up centralized vaccination and standardizing publicity and training.
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The yellow fever (YF) attenuated live vaccine 17D is one of the oldest attenuated live vaccines and historically well known for its good immunogenicity and safety. Because of the high safety of YF attenuated live vaccine 17D, its genome is used as the backbone of recombinant vaccines that deliver flavivir-uses or non-associated antigens. With the prevalence of YF, the demand for YF attenuated live vaccines is increasing. At present, there is insufficient supply of YF attenuated live vaccines in the world. Much atten-tion has been paid to YF attenuated live vaccines. In this paper, the quality, use and prospect of YF attenu-ated live vaccine are reviewed.
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Objective To evaluate the safety and immunogenicity of one booster dose of inactivated hepatitis A vaccine in young adults.Methods The subjects were selected from participants in the clinical trial of immunogenicity of inactivated and attenuated live hepatitis A vaccine in young adults.Eligible subjects were those who had received one dose of inactivated or attenuated hepatitis A vaccine,could be contacted and were sero-negative before primary vaccination.All qualified subjects were immunized with one booster dose of inactivated hepatitis A vaccine.The blood samples were collected before booster dose vaccination and 28 days after the immunization.Anti-HAV antibody titer ≥20 mIU/ml was considered to be sero-protected against hepatitis A virus.Results The GMCs in the inactivated HAV vaccine group and attenuated live vaccine group before booster dose vaccination were 70.80 mIU/ml and 50.12 mIU/ml,respectively,and the sero-protection rates were 94.7％ and 65.0％,respectively.After the vaccination of the booster dose,the sero-protection rates in both groups were 100.0％,and the GMCs were 2 816.09 mIU/ml and 2 654.55 mIU/ml,respectively.Conclusion The GMCs and sero-protection rates of anti-HAV antibody in young adults declined after three years of the primary vaccination.However,the higher GMC and sero-protection rate were observed in the inactivated vaccine group than in the attenuated live vaccine group.Significant increases of GMC levels were observed in both groups after one booster dose vaccination.
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Objective To evaluate the safety and immunogenicity of one booster dose of inactivated hepatitis A vaccine in young adults.Methods The subjects were selected from participants in the clinical trial of immunogenicity of inactivated and attenuated live hepatitis A vaccine in young adults.Eligible subjects were those who had received one dose of inactivated or attenuated hepatitis A vaccine,could be contacted and were sero-negative before primary vaccination.All qualified subjects were immunized with one booster dose of inactivated hepatitis A vaccine.The blood samples were collected before booster dose vaccination and 28 days after the immunization.Anti-HAV antibody titer ≥20 mIU/ml was considered to be sero-protected against hepatitis A virus.Results The GMCs in the inactivated HAV vaccine group and attenuated live vaccine group before booster dose vaccination were 70.80 mIU/ml and 50.12 mIU/ml,respectively,and the sero-protection rates were 94.7％ and 65.0％,respectively.After the vaccination of the booster dose,the sero-protection rates in both groups were 100.0％,and the GMCs were 2 816.09 mIU/ml and 2 654.55 mIU/ml,respectively.Conclusion The GMCs and sero-protection rates of anti-HAV antibody in young adults declined after three years of the primary vaccination.However,the higher GMC and sero-protection rate were observed in the inactivated vaccine group than in the attenuated live vaccine group.Significant increases of GMC levels were observed in both groups after one booster dose vaccination.
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Objective To analyze the characteristics of adverse reactions for varicella attenuated live vaccine (VarV) in Henan Province from 2011 to 2016, in order to evaluate the immunization safety related to VarV. Methods The adverse reaction data and vaccination doses of VarV in Henan Province from 2011 to 2016 were collected through the China Information Management System for Immunization Programming. The descriptive methodology was used for data analysis. Results A total of 686 adverse reactions cases were reported in Henan Province from 2011 to 2016, and the average reported incidence rate was 16.89 per 100000 dose. The ratio of male to female was 1.14:1, and 80.61% cases occurred between 1 and 2 years old, and the reported incidence rate was 13.62 per 100000 dose. And 32.80% cases were reported from April to June, and the reported incidence rate was 5.54 per 100000 dose. The cases were mainly concentrated in Zhengzhou, Luoyang, Zhoukou and Xinyang. Most cases occurred after the first dose and within 1 d after vaccination. The main diagnoses of adverse reactions were fever, local swelling, indurations and transient anaphylactic disorders. The reported incidence rate of anaphylactic shock and fever convulsion were 0.37 per 100000 dose and 0.12 per 100000 dose respectively. All cases were recovered or got better. Conclusion The safety of VarV was good in Henan Province. However, the surveillance should focus on the anaphylactic shock and fever convulsion and other serious rare adverse reaction.
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Objective To evaluate the effectiveness and safety of varicella attenuated live vaccine ( VarV) produced by A Co. Ltd. Methods We selected 3 provinces in China and enrolled 15 002 children aged 3-<11 in this random, multicenter study. Participants were randomly divided into two groups: the ex-perimental group and the control group. Every varicella case was collected and recorded to calculate the vac-cine efficacy. Vaccine safety was assessed by means of spontaneous report and regular follow-up visits. Re-sults During the observation period, the incidence of varicella was 0. 147% in the experimental group and 1. 155% in the control group (P<0. 001). The vaccine efficacy was 87. 27%. The adverse reaction rate af-ter vaccination was lower than the rates reported in other literatures. Conclusion The VarV produced by A Co. , Ltd. in China was effective and safe in preventing varicella.
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OBJECTIVE:To observe the safety and immunological effects of Measles-mumps-rubella(MMR)attenuated live at-tenuated vaccine in children. METHODS:300 children aged 8-12 months receiving inoculation were selected from Changsha Hospi-tal for Maternal and Child Health Care during Jan. 2015-Apr. 2016 to observe safety and immunological effects. Those children were divided into MMR group,measles vaccine group,mumps vaccine group and rubella vaccine group according to vaccine type, with 75 cases in each group. The occurrence of ADR in 72 h were compared among 4 groups after inoculation;venous blood of chil-dren was collected before vaccination and 5 months after vaccination,and the antibody positive test was carried out by micro coagu-lation inhibition (HI) test;HI antibody titer was recorded after immunization,and positive rate and genometric meantiter(GMT) were calculated. RESULTS:The incidence of ADR in 4 groups were 9.33%,8.00%,8.00% and 10.67%,respectively. No local ADR was found in 4 groups;among systemic ADR,the incidence of fever was higher than that of other clinical manifestations,be-ing 4.00%,4.00%,4.00% and 5.33%;there was no statistical significance in the incidence of ADR among 4 groups(P>0.05). Measles,mumps and rubella antibody positive rates of MMR group were 100%,92.00% and 100%,respectively;antibody posi-tive rates of measles vaccine group,mumps vaccine group and rubella vaccine group were 100%,85.33% and 100%,respective-ly;there was no statistical significance in same antibody positive rate among 4 groups(P>0.05). GMT of measles in MMR group and measles vaccine group were 1∶41 and 1∶27,that of mumps in MMR group and mumps vaccine group were 1∶6.3 and 1∶6.2, there was no statistical significance (P>0.05);GMT of rubella in MMR group and rubella vaccine group were 1∶320 and 1∶849, with statistical significance (P<0.05). CONCLUSIONS:Compared to traditional single vaccine,MMR dose not increase the inci-dence of ADR and not influence positive rate,but GMT of rubella increases significantly,to which should be paid attention.
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Enterovirus 71 (EV71) is one of the primary causative agents of hand, foot and mouth disease in children and closely associated with severe neurological complications and even deaths.EV71 outbreaks have occurred throughout the Asia-Pacific region since 1990s, posing global public health threat;however, no specific therapeutic strategy exists for severe EV71 infection.Several inactivated vaccine products have entered or finished the clinical trial stage, and some novel vaccine candidates, including live attenuated, subunit, and virus-like particle, show great potential for further develop-ment.This review summarizes the present situation and progress in the development of EV71 vaccines.
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Objective To analyze the characteristics of adverse events following immunization ( AEFI) with varicella attenuated live vaccine ( VarV) in Hebei province during 2012—2014, to evaluate the safety of VarV and to provide supportive evidences for planning chicken pox prevention and control strate-gies in Hebei province.Methods The AEFI data associated with VarV in Hebei province during 2012 to 2014 were collected from the national AEFI information management system and were analyzed by using the method of descriptive epidemiology.Results A total of 239 cases reported during 2012 to 2014 were col-lected from the national AEFI information management system, with a male to female ratio of 1.44 ∶1.The estimated incidence rate was 25.51 per 100 000 doses.One case was serious AEFI with an incidence rate of 0.11 per 100 000 doses.Most of the AEFI cases were children under 3 years old and identified in scattered inhibiting children and kindergarten kids.The main symptoms of common vaccine reactions were fever, local swelling and induration .The rare vaccine reactions were presented as anaphylactic rashes .Conclusion The reported incidence rate of VarV associated AEFI in Hebei province was less than expected.However, the estimated incidence rate of common vaccine reactions in Hebei province was higher than that showed on the Analysis on Surveillance Data of Post-marketing Immunization Safety for Varicella Attenuated Live Vac-cine in China, 2010—2012.Attentions to the AEFI after immunization with VarV should also be paid in fu-ture.
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Objective To measure the titers of varicella live attenuated vaccines ( VarV) during the process of transportation and storage in different seasons and communities of Minhang Distract, Shang-hai, to evaluate the operation of cold chain system and the thermal stability of vaccines and to provide refer-ences for the management, introduction, research and development of vaccine in future.Methods Four communities with high outbreak rates of varicella during 2012 to 2013 and four communities with low out-break rates were randomly selected from 13 communities in Minhang District, Shanghai.The titers of VarVs were detected by using the quantitative plaque assay before and after 30 days of storage in November 2013 and February, May, August 2014.Results The overall rate of qualified VarVs was 90.63% with a geo-metric mean titer (GMT) of 3.67 (LgPFU/0.5 ml).96.88%of the VarVs produced by company C met the quality standard with a GMT of 3.89 ( LgPFU/0.5 ml) followed by those produced by company B with a rate of 91.67%and a GMT of 3.75 ( LgPFU/0.5 ml) .The rate of qualified VarVs produced by company A was the lowest, which was 80.00%, with GMT of 3.29 (LgPFU/0.5 ml).There were significant differences in the rates of qualified VarV among the three companies (χ2=8.288, P=0.016).The rate of qualified vac-cines in communities close to the Shanghai Minhang Center for Disease Control and Prevention ( Minhang CDC) was 91.67%, while 100%of the vaccine samples collected form the communities at a middling dis-tance from or far from the Minhang CDC met the quality standard.No significant difference in the rate of qualified vaccine was found among the three types of communities (χ2=3.441, P=0.179).The quarterly rates of qualified vaccines produced by B and C companies were 100%except for the third quarter.The rates of qualified vaccines produced by A, B and C companies in the third quarter were respectively 70.00%, 66.67%and 87.50%.No statistical differences in the quarterly rates of qualified vaccines were found among the three companies (χ2=1.25, P=0.7412;χ2=6.545, P=0.088; χ2=6.194, P=0.103).No statistical differences in the rates of qualified vaccines before and after 30 days of storage were found among the three companies (χ2=0.625, P=0.347;χ2=0.000, P=1.000;χ2=2.065, P=0.492).Conclusion A well-managed and-operated cold chain system was implemented in Minhang District in the storage and transport of vaccines as well as other related links.The thermal stability of vaccines produced by company C was better than those of the other two companies.A surveillance for the titers of vaccines produced by com-pany A should be strengthened.
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Objective: To develop attenuated strains of Salmonella enterica serovar Typhi (. S. typhi) for the candidate vaccine by osmolar stress. Methods: S. typhi SS3 and SS5 strains were isolated from asymptomatic typhoid carriers in Namakkal, Tamil Nadu, India. Both strains were grown in LB (Luria Bertani) medium supplemented with various concentration of NaCl (0.1-0.7M) respectively. The effect of osmolar stress was determined at molecular level by PCR using MGR 06 and MGR 07 primers corresponding to ompR with chromosomal DNA of S. typhi SS3 and SS5 strains. Attenuation by osmolar stress results in deletion mutation of the S. typhi strains was determined by agglutination assays, precipitation method, SDS PAGE analysis and by animal models. Results: The 799 bp amplified ompR gene product from wild type S. typhi SS3 and SS5 illustrate the presence of virulent gene. Interestingly, there was only a 282 bp amplified product from S. typhi SS3 and SS5 grown in the presence of 0.5, 0.6 and 0.7 M NaCl. This illustrates the occurrence of deletion mutation in ompR gene at high concentration of NaCl. Furthermore, both the wild-type and mutant S. typhi outer membrane SDS-PAGE profile reveals the differences in the expression of ompF, ompC and ompA proteins. In mice, wild type and mutant strains lethal dose (LD
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Objective To summarize the adverse events of Measles,mumps,rubella combined attenuated live vaccine (MMR) during 2008 in Changning District of Shanghai.To research the effective monitoring pattern of adverse event following immunization (AEFI),and to provide evidence for establishing the safe monitoring system.Methods Using MMR as the surveillance vaccine,the AEFI monitoring research with the active and passive methods was implemented.Results 95 reports were collected.Most of the adverse events were common.The imformation from the active method was more than the imformation from the passive method.It was established the communication mechanism of the Centers for Disease Control and Prevention (CDC) between the different levels.Conclusion Active and passive methods will improve the susceptibility and the utilization rate of data reporting.
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Objective To ensure the quality of live attenuated measles vaccine on the market,viral titers were determined as the market surveillance test.Methods The measles vaccine was sampled from sites located in 24 provinces (cities,autonomous regions) of China,including provincial CDC,municipal CDC,county CDC,and primary users.The virus titer of samples was tested to evaluate the quality status of measles vaccine on the market.Results For all the 54 lots of measles vaccine sampled in this study,the virus titers were in compliance with the requirements of the China Pharmacopeia Vol.III (2005 edition).In comparison with the original test results provided by the manufacturers,the mean virus titer was decreased 0.2 lg?0.3.Conclusion Viral titers of measles vaccine batches sampled from the market were all in compliance with the requirements of the China Pharmacopeia Vol.III (2005 edition).It showed that the measles vaccine in China market has good stability,and the cold chain system for measles vaccine conveyance and storage could ensure the vaccine efficacy.
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Objective To develop measles and Japanese encephalitis(JE)combined attenuated live vaccine. Methods The independent development of China′s Shanghai 191 measles vaccine strains and Japanese encephalitis SA14-14-2 vaccine strains were selected to prepare two of monovalent vaccines solution,which were used to conduct the interference test,the ratio test,the screening test of protection agent,the screening test of dilution,and the alternative of the curve of freeze-dried.Results The preparation technology of measles and Japanese encephalitis combined live attenuated vaccine was determined.The batches of the products met the quality requirement of the three kinds of monovalent vaccine in the Pharmacopoeia of the people's Republic of China(edition 2005,volume 3).The cross-interference and increased response were not found in the animal test,and the immune response of mouse was not influenced,which indicated the safety and immunogenicity of with good combined vaccine.Conclusion Measles and Japanese encephalitis combined attenuated live vaccine was developed successfully.