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Abstract To assess the safety of varicella vaccine (VarV) by conducting post-marketing surveillance on adverse events following immunization (AEFI) in Jiangsu Province, China. Methods We utilized the AEFI Information System of mainland China to monitor and categorize adverse reactions associated with VarV. Results The incidence rate of AEFI was significantly higher after the first dose (48.79/100,000 doses) compared to the second dose (45.18/100,000 doses) (χ2 = 4.63, P = 0.031). Regional variations in AEFI incidence were observed within Jiangsu Province. Common reactions comprised 90.96% of AEFIs, while rare reactions and coincidental events accounted for 6.59% and 0.51%, respectively. Notably, there were no adverse events linked to vaccine quality, program errors, psychogenic reactions, or fatalities. Over 96% of AEFIs occurred within three days of VarV administration, with redness at the injection site (2.6 cm to 5 cm in diameter) being the most frequently observed symptom. Conclusion VarV demonstrates a commendable safety profile. Although there was a slight increase in AEFI incidence between 2022 and 2023, common vaccine reactions were predominantly observed, and the rates of rare reactions remained very low.

Despite coverage of two doses of mumps-containing vaccines, mumps epidemics persist among children and young adults in China. This study aimed to analyze the epidemiological characteristics of mumps in Jiangsu Province, with a particular focus on breakthrough cases among high-incidence groups. Mumps cases reported in 2023 were systematically collected from the Infectious Disease Surveillance and Reporting System. A comprehensive descriptive epidemiological analysis was performed to elucidate the characteristics of the reported cases. A joinpoint regression (JPR) model was utilized to identify the temporal trends across various periods. Subsequently, immunization information for cases under 15 years of age was obtained through the Jiangsu Province Vaccination Integrated Service Management Information System to identify breakthrough cases and conduct exploratory analyses. A total of 4142 mumps cases were reported in Jiangsu Province in 2023, yielding an annual incidence rate of 4.86/100,000. A total of 81.75% of the cases were students and childcare children, and the gender ratio was 1.5:1 (male/female). The JPR model analysis of weekly reported cases identified five distinct trend segments (1st: 1–8, weekly percent change (WPC) = 26.67 *; 2nd: 9–28, WPC = 3.11 *; 3rd: 29–34, WPC = −5.31; 4th: 35–37, WPC = 15.48; 5th: 38–52, WPC = −4.06 *), and the gender subgroups demonstrated similar trends to the overall pattern. Notably, 89.14% (3692/4142) of the total cases were among individuals under 15 years, with 96.02% (3545/3692) having been vaccinated against mumps. The number of single-dose breakthrough cases (SdBCs) was approximately fourfold (2847/698) that of two-dose breakthrough cases (TdBCs). The main population composition of TdBCs was children aged 0–5 years old, and the classification was dominated by childcare children and scattered children. The median time interval between initial immunization and onset were shorter in TdBCs than in the SdBCs group, and the median time interval between the last immunization and onset was interestingly similarly shorter. However, these situations were interestingly reversed in 105 laboratory-confirmed breakthrough cases. Therefore, the current vaccination strategies have demonstrated tangible effectiveness in preventing and controlling mumps. However, the high incidence of breakthrough cases among high-risk pediatric populations indicates that mumps immunization strategies still deserve more attention and research for better herd protection.

BackgroundThis study is to evaluate the safety of two kinds of PCV13 carriers by monitoring the occurrence of adverse event following immunization (AEFI) after the launch of two kinds of PCV13 carriers in Jiangsu Province, China.MethodsThe AEFI Information System (CNAEFIS) of mainland China was used to monitor the incidence and classification of adverse reactions of the CRM197-carrier protein PCV13 and TT-carrier protein PCV13 vaccines.ResultsThere was no statistical difference between the cumulative reported incidence of AEFI between the two vaccines from 2020 to 2022 (χ2 = 1.991, p

Mumps reemergence has been reported in developed countries with high levels of two-dose mumps-containing vaccine (MuCV) coverage. The effectiveness of the two-dose MuCV may be compromised by limitations in the persistence of immunity. This prospective cohort study evaluated the persistence of immunity of a two-dose MuCV in children aged 3–7 years from 2015 to 2020. Persistence of antibody to mumps, determined as the geometric mean antibody concentration (GMC), and seropositivity were analyzed for both repeated measurements from three follow-ups and on each cross-section, respectively. A total of 105 eligible subjects were recruited. Their overall seropositivity rate was relatively high and stable (92.4%–84.8%), while the overall GMC decreased from 547.6 U/ml to 333.3 U/ml. Analysis of waning immunity in 91 participants showed a significant and consistent downward trend for GMC, which differed significantly in boys and girls. The overall seropositivity rate decreased slightly from 2015 (95.6%) to 2016 (92.3%) but both were significantly higher than in 2018 (84.6%). The rates in girls remained stable, while those in boys declined to 75% in 2018. The seropositivity rate of the cross-section level decreased from 95.4% to 86.4% in 4 years. Although two-dose MuCV may result in a high level of immunity, antibody concentrations decay over 2 years after the second dose. Children with waning immunity after receiving two doses, especially boys, require further surveillance at 4 years and later to avoid future mumps epidemics. Clinical trial registration: NCT02901990.

Background: The purpose of this paper was to analyze the prevalence of hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs), and hepatitis B core anti-body (anti-HBc)in1-29 years old living in the most populous eastern province of China,22 years after introduction of hepatitis B vaccine (HepB) vaccination of infants and provide provincial baseline data for developping a better prevention and control plan for hepatitis B virus (HBV)in Jiangsu Province, China Methods: The incidence rates of HBV in Jiangsu province from 2004 to 2014 were obtained from the National Notifiable Disease Reporting System (NNDRS). A stratified cluster random sampling method was used to select 3,002 participants aged 1–29 years across 13 HBV monitoring points throughout the province, which had been classified as either urban or rural. HBV serological markers were measured by Abbott microparticle enzyme immunoassay (MEIA) kits (Abbott Laboratories, Chicago, Illinois). Results: The incidence of hepatitis B decreased by approximately 71.44% in Jiangsu province between 2004 and 2014. Serological assessments showed that the prevalence of the HBsAg, anti-HBc, and anti-HBsin the 1–29 age group were 1.20%, 5.33%,and 66.89%, respectively. There was a significantly lower prevalence of HepB who were vaccinated than in unvaccinated subjects (0.46% vs 14.93%, p

Abstract Objective Adverse events following immunization is an important factor influencing public trust in vaccination. Publicizing its incidence timely can increase public trust. The aim of this study is to describe the incidence and characteristics of adverse events following immunization in Jiangsu province of China from 2015 to 2018. Methods All information of adverse events following immunization (AEFIs) was gained from Jiangsu Province Vaccination Integrated Service Management Information System. The reported AEFI trend was analyzed using Chi-square test. Results A total of 77,980 AEFI cases were reported through the AEFI system; Among which, 77,731 were classified as non-serious AEFI cases and 249 were serious AEFI cases. The male to female ratio was 1.31:1, cases less than 7 years old accounted for 97.7%. The total estimated AEFI rate was 62.70/100,000 doses. By severity, 60.75/100,000, 4.46/100,000 and 0.11/100,000 AEFI cases were common vaccine reaction, rare vaccine reaction, and serious rare vaccine reaction, respectively. The top two serious AEFI were thrombocytopenic purpura and febrile. The incidence rates showed the increasing trend and the linear trend of the increasing incidence rates passed the significant test at 0.05 levels. Conclusion The sensitivity of AEFI monitoring in Jiangsu Province is increasing and higher than the national average and most countries. The majority of AEFI cases were common adverse reactions, while the serious vaccine reactions caused by vaccines were extremely low. To elevate the sensitivity of AEFI surveillance may reduce the incidence of developing serious AEFI cases.

Background During the period of immunization with a single-dose measles-mumps-rubella (MMR) vaccine, which has been available since 2008in China, the incidence of mumps in children aged 2–5 years has been high. The aim of this study was to determine the immunity profile of mumps in children aged 2–5 years as part of the assessment of the MMR vaccination strategy. Methods A cross-sectional survey of IgG antibodies against mumps virus in children aged 2–5 years was performed. Analysis by enzyme-linked immune sorbent assay(ELISA)was performed to measure IgG antibodies against mumps virus in the sera of 2-to5-year-old children who had been vaccinated with at least one dose of MMR vaccine. Results Mumps outbreaks mainly occurred in kindergarten and primary schools and primarily involved children in kindergarten from 2015-2016 in Jiangsu Province. In total, 4,033 children were surveyed. The overall seroprevalence of mumps antibodies was 79.0% (95% CI:78.4–79.6), and the geometric mean concentration (GMC) was 323.6 mIU/ml (309.0–338.8). Both univariate and multivariate survival analysis of seroprevalence showed that several factors contributed to having significant seroprevalence among the 2-to-5-year-old group (P

Vaccination has been one of the major revolutions in the history of human health. Vaccination programs have targeted entire populations such as infants or elderly subjects as a matter of being efficient with time and resources. These general populations are heterogeneous in terms of factors such as ethnicity, health status, and socio-economics. Thus, there have been variations in the safety and effectiveness profiles of certain vaccinations according to current population-wide strategies. As the concept of precision medicine has been raised in recent years, many researchers have suggested that vaccines could be administered more precisely in terms of particular target populations, vaccine formulations, regimens, and dosage levels. This review addresses the concept and framework of precision immunization, summarizes recent and representative clinical trials of among specific populations, mentions important factors to be addressed in customizing vaccinations, and provides suggestions on the establishment of precision immunization with the goal of maximizing the effectiveness of vaccines in general.

Background: The varicella vaccine is not included in the national childhood immunization schedules in China, although one-dose varicella vaccine has been suggested for susceptible children aged 1–12 years in Jiangsu Province. However, varicella epidemics and outbreaks are frequently reported. We investigated a varicella outbreak in an elementary school to explore the risk factors for varicella transmission and vaccine failure. Methods: A 1:2 matched case-control study was carried out. Participant data were collected with standardized questionnaires. For each case, we enrolled two controls: a subject with high exposure in the same classroom as the case and a subject with low exposure in a different classroom. Data regarding vaccination status and medical and exposure histories were analyzed. Results: Fifty-one cases were reported during the outbreak; 26 cases (51%) were breakthrough varicella. Varicella vaccine immunization history (P

Varicella (chickenpox) is highly contagious among children and frequently breaks out in schools. In this study, we developed a dynamic compartment model to explore the optimal schedule for varicella vaccination in Jiangsu Province, China. A susceptible-infected-recovered (SIR) model was proposed to simulate the transmission of varicella in different age groups. The basic reproduction number was computed by the kinetic model, and the impact of three prevention factors was assessed through the global sensitivity analysis. Finally, the effect of various vaccination scenarios was qualitatively evaluated by numerical simulation. The estimated basic reproduction number was 1.831 ± 0.078, and the greatest contributor was the 5–10 year-old group (0.747 ± 0.042, 40.80%). Sensitivity analysis indicated that there was a strong negative correlation between the second dose vaccination coverage rate and basic reproduction number. In addition, we qualitatively found that the incidence would significantly decrease as the second dose vaccine coverage expands. The results suggest that two-dose varicella vaccination should be mandatory, and the optimal age of second dose vaccination is the 5–10 year-old group. Optimal vaccination time, wide vaccine coverage along with other measures, could enhance the effectiveness of prevention and control of varicella in China.

Abstract Background In recent years, outbreaks of varicella have continued to occur, and the coverage rate of varicella vaccine in Jiangsu Province, China, remains unclear. This study aims to analyse the levels of immune antibody against varicella and obtain a comprehensive understanding of the varicella attenuated live vaccine (VarV) coverage rate in children aged 1–9 years in Jiangsu Province. Methods From June to October 2016, a cross-sectional survey was conducted to collect 3631 serum samples from healthy children aged 1–9 years in Jiangsu Province. The immunoglobulin G (IgG) antibody levels of varicella were detected by enzyme-linked immunosorbent assay (ELISA). Results The VarV coverage rate of healthy children was only 43.1% (95% CI: 41.1–44.7%). The seroprevalence after vaccination with a single dose of VarV was only 57.1%, and the overall seropositivity and geometric antibody titre (GMC) were 43.5% and 225.4 mU/ml, respectively. The seropositivity was significantly higher in girls than in boys (χ2 = 18.82, P

A single dose of the measles-mumps-rubella (MMR) vaccine has been applied in routine immunizations for children in China; however, the Immunoglobulin G (IgG) antibody level of mumps in children from kindergarten to early school age with MMR vaccine immunization history has not been elucidated. This study aimed to describe the immunity profile of children from kindergarten to early school age to identify the susceptible population. In Jiangsu Province, a cross-sectional survey of 4- to 8-year-old children who were vaccinated with at least one dose of MMR vaccine was conducted. IgG antibody results were analyzed by employing both the Enzyme-Linked Immunosorbent Assay (ELISA) cutoff values and the mixture model. A total of 7436 eligible subjects were enrolled: 3386 subjects were in kindergarten, and 4450 were in primary school. The overall seroprevalence (75.4%, 95% CI: 74.4%-76.4%) and Geometric mean concentration (GMC, 201.4U/ml, 95% CI: 194.1–209.4) of mumps antibodies in 2016 were low. The seroprevalence of children in kindergarten (78.1%, 95% CI: 76.6%-79.4%) was significantly higher than that of children in primary school (73.2%, 95% CI: 71.2%-74.6%). The GMC was negatively correlated with the time of inoculation (F = 32.17, P = 0.002). The mixture model enables a more comprehensive understanding of serological results by investigating four levels of antibody response, suggesting that there is a small fraction of the population with waning immunity. Children in kindergarten and primary school whom had received one dose of MMR vaccine were at a higher risk of mumps infection, particularly the 7-year-old group in the central region. Therefore, the single-dose MMR vaccine schedule has a limited impact on mumps control and prevention, and a two-dose MMR vaccine schedule should be introduced.

Background: In China, one dose measles-mumps-rubella vaccine (MMR) was administered to children aged 18–24 months. The mumps incidence was still high. Data on the waning immunity to mumps after MMR vaccination are limited. This study aimed to describe the waning immunity to mumps in kindergarten and primary school children to provide a scientific basis for confirming an optimal age for a second dose. Methods: An observational, prospective study on one-dose MMR in children in kindergarten and primary school was conducted from 2015 to 2016. Waning immunity to mumps in terms of seropositivity and geometric antibody concentration (GMC) with time was analyzed. Results: In total, 7436 eligible subjects in kindergarten (3435) and primary school (4001) were included in 2015. The overall GMC (201.7 U/ml) and seropositivity (75.4%) to mumps antibodies in 2016 were significantly lower compared to those in 2015 (218.7 U/ml, 78.4%). Asymptomatic infection occurred within one year in 8.8% of children who received one-dose MMR. Conclusions: Children who received one-dose MMR in kindergarten and primary school were at high risk of mumps infection, and waning immunity occurred with time. Determining the optimal age for the second dose of MMR in children should be prioritized to prevent mumps epidemics.

BACKGROUND: Changes in the epidemiological characteristics of measles since 2007 appeared in the Jiangsu province. Although the reported coverage with two doses of measles vaccine was greater than 95% in most regions of the province, measles incidence remained high across the whole province. Cross-sectional serological surveys of measles antibodies in the Jiangsu province of China were conducted from 2008 to 2010 to assess and track population immunity. METHODS: Measles-specific IgG levels were measured in serum samples using ELISA. GMTs and seroprevalence with 95% CIs were calculated by region, gender, and age. ANOVA and χ(2) tests were used to test for statistically significant differences between groups for GMT levels and seroprevalence, respectively. RESULTS: Seroprevalence showed a significantly increasing trend annually (CMH χ(2) = 40.32, p

Objectives To analyse the relationship between the false-positive/false-negative predictive value (FPPV/FNPV) of the HIV-antibody (HIV-Ab) test and prevalence in different Chinese population groups. Methods HIV prevalence among different population groups was obtained by a screening survey of blood donors and the national HIV/AIDS surveillance programme in China. Given the sensitivity and specificity of a test kit and the prevalence of HIV infection, the estimated values of FPPV/FNPV were calculated using Bayes' formula. The actual value of FPPV of blood donors was obtained by screening 1,195,286 blood donors. Results This study indicates that the FPPV of HIV-Ab enzyme-linked immunosorbent assay (ELISA) assays varies widely in different Chinese populations: about 99.5% in the blood donor population, but only 3.2% in the injecting-drug users in high-risk areas. In 1,195,286 sera specimens from the blood donors, 2439 specimens were HIV-Ab positive by third ELISA, and 11 HIV cases were confirmed by Western blot. The HIV prevalence of the blood donor population in this survey was 0.0009% (11/1,195,286), but the HIV-Ab positive rate of third ELISA is 0.2% (2439/1,195,286) and 222 times higher than the prevalence. Conclusions Evaluation of HIV prevalence through the HIV-Ab positive rate by third ELISA will significantly overestimate the true prevalence in a low-prevalence population. Individual HIVinfection status should be taken into consideration when analysing the results of HIV-Ab tests in a population with low infection. [ABSTRACT FROM AUTHOR]