Immunogenicity and safety of concomitant administration of the chinese inactivated poliovirus vaccine with the diphtheria-tetanus-acellular pertussis (DTaP) vaccine in children: A multicenter, randomized, non-inferiority, controlled trial

Key pointConsidering that vaccination with the sIPV and DTaP overlap at the ages of 3 and 4 months in China, to reduce the burden of treatment on parents and increase vaccination coverage rates, we designed a postmarket clinical study of co-administration.BackgroundThe Sabin-strain-based inactivated poliovirus vaccine (sIPV) and the diphtheria-tetanus-acellular pertussis vaccine (DTaP) have been licensed in China for many years. To conduct a clinical study on the safety and immunogenicity of the sIPV when administered concomitantly with the DTaP.MethodsThe study population was divided into three groups: group 1 was the sIPV+ DTaP concomitant administration group, group 2 was the sIPV inoculation group, and group 3 was the DTaP inoculation group. Blood samples were collected prevaccination and 30 days postvaccination, and serum antibody levels were detected.ResultsThis study showed that the seropositive and seroconversion rates of type 1, 2 and 3 poliovirus in group 1 were higher than those in group 2, with no statistically significant difference after vaccination (P>0.05). Groups 1 and 3 also showed similar responses for all vaccine antigens except anti-FHA (97.65 (94.09-99.36) vs. 100 (97.89-100)). The geometric mean titers (GMTs) for the DTaP and sIPV among the groups were comparable, and the non-inferiority t test result was P<0.001. The number of local adverse events (AEs) reported in group 1 (29.91%) were larger than those in group 2 (12.39%) and group 3 (21.93%), among which the most common was redness. Similarly, the most common systemic AE was fever. All 5 severe AE (SAE) cases were determined by experts to be unrelated to the vaccines during the study.ConclusionsThe evidence of similar seroconversion and safety with co-administered DTaP and sIPV supports the co-administration supports the introduction of a strategy of simultaneous administration of both vaccines into routine infant immunization, and it could increase vaccination coverage and protect more infants from morbidity and mortality from these related diseases.Clinical Trial Registrationhttps://clinicaltrials.gov/ct2/show/NCT04054882?term=NCT04054882&cntry=CN&draw=2&rank=1, identifier NCT04054882

Seroprevalence of avian influenza A (H5N1) virus among poultry workers in Jiangsu Province, China: an observational study

<p>Abstract</p> <p>Background</p> <p>Since 2003 to 06 Jan 2012, the number of laboratory confirmed human cases of infection with avian influenza in China was 41 and 27 were fatal. However, the official estimate of the H5N1 case-fatality rate has been described by some as an over estimation since there may be numerous undetected asymptomatic/mild cases of H5N1 infection. This study was conducted to better understand the real infection rate and evaluate the potential risk factors for the zoonotic spread of H5N1 viruses to humans.</p> <p>Methods</p> <p>A seroepidemiological survey was conducted in poultry workers, a group expected to have the highest level of exposure to H5N1-infected birds, from 3 counties with habitat lakes of wildfowl in Jiangsu province, China. Serum specimens were collected from 306 participants for H5N1 serological test. All participants were interviewed to collect information about poultry exposures.</p> <p>Results</p> <p>The overall seropositive rate was 2.61% for H5N1 antibodies. The poultry number was found associated with a 2.39-fold significantly increased subclinical infection risk after adjusted with age and gender.</p> <p>Conclusions</p> <p>Avian-to -human transmission of avian H5N1 virus remained low. Workers associated with raising larger poultry flocks have a higher risk on seroconversion.</p

Seroprevalence of Pandemic (H1N1) 2009 in Pregnant Women in China: An Observational Study

BACKGROUND: We investigated the seropositive rates and persistence of antibody against pandemic (H1N1) 2009 virus (pH1N1) in pregnant women and voluntary blood donors after the second wave of the pandemic in Nanjing, China. METHODOLOGY/PRINCIPAL FINDINGS: Serum samples of unvaccinated pregnant women (n = 720) and voluntary blood donors (n = 320) were collected after the second wave of 2009 pandemic in Nanjing. All samples were tested against pH1N1 strain (A/California/7/2009) with hemagglutination inhibition assay. A significant decline in seropositive rates, from above 50% to about 20%, was observed in pregnant women and voluntary blood donors fifteen weeks after the second wave of the pandemic. A quarter of the samples were tested against a seasonal H1N1 strain (A/Brisbane/59/2007). The antibody titers against pH1N1 strain were found to correlate positively with those against seasonal H1N1 strain. The correlation was modest but statistically significant. CONCLUSIONS AND SIGNIFICANCE: The high seropositive rates in both pregnant women and voluntary blood donors suggested that the pH1N1 virus had widely spread in these two populations. Immunity derived from natural infection seemed not to be persistent well

Impact of non-pharmaceutical interventions on the incidences of vaccine-preventable diseases during the COVID-19 pandemic in the eastern of China

Background In response to the coronavirus disease 2019 (COVID-19) pandemic, many countries have implemented mitigating non-pharmaceutical interventions. We investigated the impact of these interventions and changes in public behavior on the incidences of selected vaccine-preventable diseases (VPDs) during the COVID-19 pandemic in the eastern of China. Methods From routine monitoring data collected in the capital of eastern China’s Jiangsu Province, we extracted and analyzed the incidences of influenza; hand, foot and mouth disease (HFMD); varicella; mumps; pertussis; and hepatitis B. We also investigated the changes in public behavior during the COVID-19 pandemic through telephone interviews and questionnaire surveys. Results Compared with the baseline (2017–2019), the incidences of all VPDs except influenza declined significantly in 2020 (HFMD decreased by 79.92%, varicella decreased by 7.71%, mumps decreased by 2.03%, pertussis decreased by 78.91%, and hepatitis B decreased by 0.31%). The reduction in reported cases in children (0–14 years) was greater than that in adults, and pertussis had the largest reduction (approximately 80%) in children. Influenza peaks in winter; in the three years before the COVID-19 pandemic, Influenza rates took an average of 10 weeks to recede to their lowest levels after the Spring Festival, while in 2020, this took only 1 week. A total of 366 outbreaks with 20,205 cases were reported during the COVID-19 pandemic. Among the participants in the study, 94.2% of the interviewees avoided going to high-risk areas, 82.4% avoided going to crowded places, 92.9% wore masks when going out,88.4% washed their hands frequently, and 67.9% maintained social distance. Conclusions Our study showed significant reductions in the incidences of VPDs after the implementation of a series of non-pharmaceutical interventions during the COVID-19 pandemic

Ten years of experience and progress of electronic immunization registry system in Jiangsu Province, China

The electronic immunization registry system (EIRs) can improve the vaccine coverage monitoring significantly. The EIRs in Jiangsu Province, China was set up since 2006. In this paper, the mechanism and structure of the EIRs were summarized, and then some function of this system were illustrated. The application of the EIRs was believed to be an effective health management and electronic vaccine record quality improvement tool in China. The experience and progress we gained could provide a valuable example for other countries

Surveillance of adverse events following the introduction of inactivated poliovirus vaccine made from Sabin strains (sIPV) to the Chinese EPI and a comparison with adverse events following inactivated poliovirus vaccine made from wild strains (wIPV) in Jiangsu, China

One dose of inactivated poliovirus vaccine (IPV) was introduced into the Chinese Expanded Program on Immunization (EPI) in 2016. IPV made from Sabin strains (sIPV) was newly licensed in China and its safety has been concerned. This study aimed to evaluate the safety of sIPV and provide a comparison with conventional IPV made from wild strains (wIPV). We collected all IPV-related AEFI reports in Jiangsu from the Chinese National Adverse Events Following Immunization Information System (CNAEFIS) for 2016–2019. We obtained the administered doses of IPV from the Jiangsu provincial Electronic Immunization Registries System (JSEIRS). The AEFI reporting rates per 100,000 doses of vaccine administered were compared for sIPV and wIPV. A total of 699 sIPV and 908 wIPV AEFI cases were collected by CNAEFIS in Jiangsu during 2016–2019. The overall AEFI reporting rates were 53.02 per 100,000 doses and 41.25 per 100,000 doses for sIPV and wIPV, respectively (P < .001). For both sIPV and wIPV, the AEFIs were mainly classified as common adverse reactions. The reporting rate of common adverse reactions was higher for sIPV than for wIPV (P < .001). The most frequently reported symptoms/signs were fever, persistent crying, injection site erythema/swelling, rash, and injection site induration. Only 1.14% of sIPV-associated and 2.31% of wIPV-associated AEFI cases were diagnosed as serious. No difference in reporting rate was observed for serious AEFIs (P = .272). sIPV has a favorable safety profile, although it exhibits a slightly higher reporting rate of common adverse reactions than wIPV

Analysis of epidemiological serosurvey of hepatitis B virus among people under 29 years of age in Jiangsu Province, China

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 < .0001). Among these the ages of 1–29, the coverage rate drops from 97.7% to 56.6% with age,andthe timely rate among people aged 1–14 years was 90.93%. Conclusions: Since the HepB was integrated into the immunization programme in Jiangsu province,the rate of hepatitis B reported and the prevalence of HBsAg decreased significantly, and the coverage of HepB and the vaccination rate within 24 hours after birth have played an important role in reducing HBV infection

High risk of mumps infection in children who received one dose of mumps-containing vaccine: waning immunity to mumps in children aged 2-5 years from kindergartens in Jiangsu Province, China

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 < .05). The seroprevalence of children with a single-dose MMR vaccine regimen (78.4%, 95% CI: 77.8–80.4) was significantly lower than that of children with a two-dose MMR vaccine regimen (96.5%, 95% CI: 88.6%-96.1%). The seroprevalence rate was negatively correlated with time since inoculation (P < .01). Conclusion Children who received a single dose of MMR vaccine in kindergarten, particularly the 2-year-old group in the northern region of Jiangsu Province, China, are at high risk of mumps infection. Our study demonstrates thata single-dose MMR vaccine regimen has a limited effect on controlling mumps, which highlights the benefit of introducing a two-dose MMR vaccine schedule

Genetic characteristics of the coxsackievirus A24 variant causing outbreaks of acute hemorrhagic conjunctivitis in Jiangsu, China, 2010.

During September 2010, an outbreak of acute hemorrhagic conjunctivitis reemerged in Jiangsu, three years after the nationwide epidemic in China in 2007. In total, 2409 cases were reported, 2118 of which were reported in September; 79.8% of those affected were students or teachers, with a median age of 16 years. To identify and demonstrate the genetic characteristics of the etiological agent, 52 conjunctival swabs were randomly collected from four different cities. After detection and isolation, 43 patients were positive for coxsackievirus A24 variant according to PCR and 20 according to culture isolation. Neither adenovirus nor EV70 was detected. A phylogenetic study of the complete 3Cpro and VP1 regions showed that the Jiangsu isolates clustered into a new lineage, GIV-C5, with two uniform amino-acid mutations that distinguished them from all previous strains. Another new cluster, GIV-C4, formed by Indian isolates from 2007 and Brazilian isolates from 2009, was also identified in this study. Interestingly, our isolates shared greatest homology with the GIV-C4 strains, not with the isolates that were responsible for the nationwide acute hemorrhagic conjunctivitis epidemic in China in 2007. Although all our isolates were closely related, they could be differentiated into two subclusters within GIV-C5. In conclusion, our study suggests that a new cluster of coxsackievirus A24 variant that had already evolved into diverse strains was associated with the acute hemorrhagic conjunctivitis outbreaks in Jiangsu in September 2010. These viruses might have originated from the virus isolated in India in 2007, rather than from the epidemic strains isolated in China in 2007