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BACKGROUND: Hepatitis E virus (HEV) is a frequently overlooked causative agent of acute hepatitis. Evaluating the long-term durability of hepatitis E vaccine efficacy holds crucial importance. METHODS: This study was an extension to a randomised, double-blind, placebo-controlled, phase-3 clinical trial of the hepatitis E vaccine conducted in Dontai County, Jiangsu, China. Participants were recruited from 11 townships in Dongtai County. In the initial trial, a total of 112 604 healthy adults aged 16-65 years were enrolled, stratified according to age and sex, and randomly assigned in a 1:1 ratio to receive three doses of hepatitis E vaccine or placebo intramuscularly at month 0, month 1, and month 6. A sensitive hepatitis E surveillance system including 205 clinical sentinels, covering the entire study region, was established and maintained for 10 years after vaccination. The primary outcome was the per-protocol efficacy of hepatitis E virus vaccine to prevent confirmed hepatitis E occurring at least 30 days after administration of the third dose. Throughout the study, the participants, site investigators, and laboratory staff remained blinded to the treatment assignments. This study is registered with ClinicalTrials.gov (NCT01014845). FINDINGS: During the 10-year study period from Aug 22, 2007, to Oct 31, 2017, 90 people with hepatitis E were identified; 13 in the vaccine group (0·2 per 10 000 person-years) and 77 in the placebo group (1·4 per 10 000 person-years), corresponding to a vaccine efficacy of 83·1% (95% CI 69·4-91·4) in the modified intention-to-treat analysis and 86·6% (73·0 to 94·1) in the per-protocol analysis. In the subsets of participants assessed for immunogenicity persistence, of those who were seronegative at baseline and received three doses of hepatitis E vaccine, 254 (87·3%) of 291 vaccinees in Qindong at the 8·5-year mark and 1270 (73·0%) of 1740 vaccinees in Anfeng at the 7·5-year mark maintained detectable concentrations of antibodies. INTERPRETATION: Immunisation with this hepatitis E vaccine offers durable protection against hepatitis E for up to 10 years, with vaccine-induced antibodies against HEV persisting for at least 8·5 years. FUNDING: National Natural Science Foundation of China, Fujian Provincial Natural Science Foundation, Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences, and the Fundamental Research Funds for the Central Universities.
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Hepatite E , Vacinas contra Hepatite Viral , Adulto , Humanos , Anticorpos Antivirais , Hepatite E/prevenção & controle , VacinaçãoRESUMO
BACKGROUND: The real-world data of long-term protection under moderate vaccination coverage is limited. This study aimed to evaluate varicella epidemiology and the long-term effectiveness under moderate coverage levels in Ganyu District, Lianyungang City, Jiangsu Province. METHODS: This was a population-based, retrospective birth cohort study based on the immunization information system (IIS) and the National Notifiable Disease Surveillance System (NNDSS) in Ganyu District. Varicella cases reported from 2009 to 2020 were included to describe the epidemiology of varicella, and eleven-year consecutive birth cohorts (2008-2018) were included to estimate the vaccine effectiveness (VE) of varicella by Cox regression analysis. RESULTS: A total of 155,232 native children and 3,251 varicella cases were included. The vaccination coverage was moderate with 37.1%, correspondingly, the annual incidence of varicella infection increased 4.4-fold from 2009 to 2020. A shift of the varicella cases to older age groups was observed, with the peak proportion of cases shifting from 5-6 year-old to 7-8 year-old. The adjusted effectiveness of one dose of vaccine waned over time, and the adjusted VE decreased from 72.9% to 41.8% in the one-dose group. CONCLUSIONS: The insufficient vaccination coverage (37.1%) may have contributed in part to the rising annual incidence of varicella infection, and a shift of varicella cases to older age groups occurred. The effectiveness of one dose of varicella vaccine was moderate and waned over time. It is urgent to increase varicella vaccine coverage to 80% to reduce the incidence of varicella and prevent any potential shift in the age at infection in China.
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Vacina contra Varicela , Varicela , Criança , Humanos , Idoso , Pré-Escolar , Varicela/epidemiologia , Varicela/prevenção & controle , Estudos Retrospectivos , Estudos de Coortes , Surtos de Doenças/prevenção & controle , Vacinação , China/epidemiologia , Vacinas Atenuadas , IncidênciaRESUMO
Hepatitis E is a significant cause of acute hepatitis, contributing to high morbidity and mortality rates, and capable of causing large epidemics through fecal-oral transmission. Currently, no specific treatment for hepatitis E has been approved. Given the notably high mortality rate among HEV-infected pregnant women and individuals with underlying chronic liver disease, concerted efforts have been made to develop effective vaccines. The only licensed hepatitis E vaccine worldwide, the HEV 239 (Hecolin) vaccine, has been demonstrated to be safe and efficacious in Phase III clinical trials, in which the efficacy of three doses of HEV 239 remained at 86.6% (95% confidence interval (CI): 73.0-94.1) at the end of 10 years follow-up. In this review, the progress and challenges for hepatitis E vaccines are summarized.
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Hepatitis E virus (HEV) is an important cause of acute hepatitis, however, is highly neglected and largely underreported. This study aimed to describe the detailed epidemiology of hepatitis E (HE) through a 10-year surveillance. A community-based active hepatitis surveillance was conducted between November 2007 and October 2017 in 11 townships of Dongtai City in China, involving 355,673 residents. Serum samples were obtained from patients presenting with hepatitis symptoms for more than 3 days. Serum alanine aminotransferase (ALT) levels greater than 2.5 times the upper limit of normal (ULN) were considered acute hepatitis. Samples were subsequently tested for IgG and IgM anti-HEV antibodies, HEV RNA, and hepatitis B surface antigen (HBsAg). The data indicated the incidence of HE fluctuated downward from 2007 to 2017, with an average annual age-standardized incidence of 17.50 per 100,000, exceeding the 10.26 per 100,000 in the National Notifiable Disease Report System (NNDRS). The incidence was notably higher among males (20.95 per 100,000) and individuals aged 50-69 years (37.47 per 100,000). Genotype 4 (HEV-4) was the predominantly circulating genotype during the study period. Furthermore, the study revealed the incidence of hepatitis with HEV and hepatitis B virus (HBV) co-infection was 4.99 per 100,000. The active surveillance system identified a higher incidence of HE compared to NNDRS, with a decreased prevalence over a 10-year period. While efforts are still needed to prevent HE in high-risk populations, including individuals with hepatitis B and the elderly.
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Anticorpos Anti-Hepatite , Vírus da Hepatite E , Hepatite E , Humanos , Hepatite E/epidemiologia , Hepatite E/virologia , China/epidemiologia , Masculino , Pessoa de Meia-Idade , Vírus da Hepatite E/genética , Vírus da Hepatite E/imunologia , Vírus da Hepatite E/classificação , Vírus da Hepatite E/isolamento & purificação , Feminino , Adulto , Idoso , Adolescente , Adulto Jovem , Incidência , Criança , Pré-Escolar , Anticorpos Anti-Hepatite/sangue , Genótipo , Lactente , Hepatite B/epidemiologia , Hepatite B/virologia , RNA Viral/genética , Coinfecção/epidemiologia , Coinfecção/virologia , Imunoglobulina M/sangue , Monitoramento Epidemiológico , Idoso de 80 Anos ou mais , Imunoglobulina G/sangue , Vírus da Hepatite B/genética , Vírus da Hepatite B/imunologia , Vírus da Hepatite B/isolamento & purificação , Antígenos de Superfície da Hepatite B/sangue , Recém-Nascido , Cidades/epidemiologiaRESUMO
Nowadays, there has been a rapid expansion of tea plantations in the mountainous areas of southwest China. However, little research has focused on the pollution problems caused by the losses of nitrogen and phosphorus from tea plantations in this area. Therefore, a field experiment was conducted using the runoff plots in situ monitoring method following farmers' conventional management from 2018 to 2020 in Guizhou Province, southwest China. The characteristics of nitrogen and phosphorus losses from tea plantation in the mountainous area were clarified, and the effect of rainfall intensity on the nitrogen and phosphorus losses were explored. 298 natural rainfall events with a total rainfall of 2258 mm were observed during the 2-year observation period, and erosive rainfall accounted for 78.1% of the total rainfall. The total surface runoff amount was 72 mm, and the surface runoff coefficient was 3.19%. The total nitrogen (TN) and total phosphorus (TP) concentrations in the surface runoff ranged from 0.68 to 14.86 mg·L-1 and 0.18 to 2.34 mg·L-1, respectively. The TN and TP losses from tea plantations were 1.47 kg N ha-1 yr-1 and 0.210 kg P ha-1 yr-1. Rainfall intensity directly and significantly affected the surface runoff and nitrogen and phosphorus loss. Where 72.6% of the cumulative rainfall, 92.5% of the total surface runoff amounts, 87.4% of total nitrogen loss, and 90.5% of total phosphorus loss were observed in rainfall events above 10 mm. Taken together, the results provide scientific guidance for quantifying the characteristics of nutrient loss in subtropical mountain tea plantations.
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Monitoramento Ambiental , Fósforo , Fósforo/análise , Monitoramento Ambiental/métodos , Nitrogênio/análise , China , Chá , Movimentos da Água , ChuvaRESUMO
Current research has long focused on soil organic carbon and soil aggregates stability. However, the effects of different long-term fertilization on the composition of yellow soil aggregates and the characteristics of the occurrence of organic carbon in the karst region of Southwest China are still unclear. Based on a 25-year long-term located experiment on yellow soil, soil samples from the 0-20 cm soil layer were collected and treated with different fertilizers (CK: unfertilized control; NPK: chemical fertilizer; 1/4 M + 3/4 NP: 25% chemical fertilizer replaced by 25% organic fertilizer; 1/2 M + 1/2 NP: 50% chemical fertilizer replaced by organic fertilizer; and M: organic fertilizer). In water-stable aggregates, soil aggregates stability, total organic carbon (TOC), easily oxidized organic carbon (EOC), carbon preservation capacity (CPC), and carbon pool management index (CPMI) were analyzed. The findings demonstrated that the order of the average weight diameter (MWD), geometric mean diameter (GWD), and macro-aggregate content (R0.25) of stable water aggregates was M > CK > 1/2M +1/2NP > 1/4M +3/4NP> NPK. The MWD, GWD, and R0.25 of NPK treatment significantly decreased by 32.6%, 43.2%, and 7.0 percentage points, respectively, compared to CK treatment. The order of TOC and EOC content in aggregates of different particle sizes was M > 1/2M +1/2NP > 1/4M +3/4NP> CK > NPK, and it increased as the rate of organic fertilizer increased. In macro-aggregates and bulk soil, the CPC of TOC (TOPC) and EOC (EOPC), as well as CPMI, were arranged as M > 1/2M +1/2NP > 1/4M +3/4NP> CK > NPK, but the opposite was true for micro-aggregates. In bulk soil treated with organic fertilizer, the TOPC, EOPC, and CPMI significantly increased by 27.4%-53.8%, 29.7%-78.1%, 29.7-82.2 percentage points, respectively, compared to NPK treatment. Redundancy analysis and stepwise regression analysis show that TOC was the main physical and chemical factor affecting the aggregates stability, and the TOPC in micro-aggregates has the most direct impact. In conclusion, the primary cause of the decrease in SOC caused by the long-term application of chemical fertilizer was the loss of organic carbon in macro-aggregates. An essential method to increase soil nutrient supply and improve yellow soil productivity was to apply an organic fertilizer to increase aggregates stability, storage and activity of SOC in macro-aggregates.
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Understanding the responses of soil bacterial community to long-term fertilization in dryland of yellow soil could provide theoretical basis for establishing scientific fertilization system and cultivating healthy soil. Based on a 25-year long-term fertilization experiment on yellow soil, we collected soil samples from 0-20 cm layer under different fertilization treatments: no fertilization (CK), balanced application of N, P and K fertilizers (NPK), single application of organic fertilizer (M), combined application of constant organic and inorganic fertilizer (MNPK), and 1/2 organic fertilizer instead of 1/2 chemical fertilizer (MNP). Illumina MiSeq high-throughput sequencing technology was used to examine the effects of different fertilization patterns on soil bacterial community structure and soil nutrient content. The main driving factors of soil bacterial community were explored. The results showed that soil pH and organic matter content under treatments with organic fertilizer increased by 11.4%-13.5% and 28.8%-52.0%, respectively, compared to that under NPK treatment. Long-term fertilization did not affect soil bacterial α diversity, but significantly affected soil bacterial ß diversity. Compared with CK and NPK treatment, treatments of M, MNP, and MNPK significantly changed soil bacterial community structure, and increased the relative abundance of Fusobacteria and Anaerobes. Four fertilization treatments increased the relative abundance of Bacteroidetes, and decreased the relative abundance of Actinomyces and Campylobacter, compared to CK. Soil pH was the most important factor affecting soil bacterial community structure. Fertilization-stimulated rare microbial taxa (Pumilomyces and Anaerobes) were more sensitive to changes in different environmental factors and were the main drivers of the formation of community versatility. In conclusion, organic fertilizer improved soil properties and fertility and changed soil bacterial community structure, which are conducive to cultivating healthy soil.
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Fertilidade , Fertilizantes , Sequenciamento de Nucleotídeos em Larga Escala , Nutrientes , SoloRESUMO
The Escherichia coli-produced human papillomavirus (HPV) 16/18 bivalent vaccine (Cecolin) has received prequalification by the World Health Organization based on its high efficacy and good safety profile. We aimed to evaluate the immunogenicity and safety of the second-generation nonavalent HPV 6/11/16/18/31/33/45/52/58 vaccine (Cecolin 9) through the randomized, blinded phase 2 clinical trial. Eligible healthy women aged 18-45 years were randomly (1:1) allocated to receive three doses of 1.0 mL (270 µg) of Cecolin 9 or placebo with a 0-1-6-month schedule. The primary endpoint was the seroconversion rate and geometric mean titer of neutralizing antibodies (nAbs) one month after the full vaccination course (month 7). The secondary endpoint was the safety profile including solicited adverse reactions occurring within 7 d, adverse events (AEs) occurring within 30 d after each dose, and serious adverse events (SAEs) occurring during the 7-month follow-up period. In total, 627 volunteers were enrolled and randomly assigned to Cecolin 9 (n = 313) or placebo (n = 314) group in Jiangsu Province, China. Almost all participants in the per-protocol set for immunogenicity (PPS-I) seroconverted for nAbs against all the nine HPV types at month 7, while two failed to seroconvert for HPV 11 and one did not seroconvert for HPV 52. The incidence rates of total AEs in the Cecolin 9 and placebo groups were 80.8% and 72.9%, respectively, with the majority of them being mild and recovering shortly. None of the SAEs were considered related to vaccination. In conclusion, the E. coli-produced 9-valent HPV (9vHPV) vaccine candidate was well tolerated and immunogenic, which warrants further efficacy studies in larger populations.
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Infecções por Papillomavirus , Vacinas contra Papillomavirus , Vacinas de Partículas Semelhantes a Vírus , Feminino , Humanos , Anticorpos Neutralizantes , Escherichia coli , Papillomavirus Humano , Papillomaviridae , Infecções por Papillomavirus/prevenção & controle , Vacinas contra Papillomavirus/efeitos adversos , Vacinas Combinadas , Vacinas de Partículas Semelhantes a Vírus/efeitos adversos , Método Duplo-CegoRESUMO
Hand, foot, and mouth disease (HFMD) is a serious disease burden in the Asia-Pacific region, including China. This study calculated the transmissibility of HFMD at county levels in Jiangsu Province, China, analyzed the differences of transmissibility and explored the possible influencing factors of its transmissibility. We built a mathematical model for seasonal characteristics of HFMD, estimated the effective reproduction number (Reff), and compared the incidence rate and transmissibility in different counties using non-parametric tests, rapid cluster analysis and rank-sum ratio in 97 counties in Jiangsu Province from 2015 to 2020. The average daily incidence rate was between 0 and 4 per 100,000 people in Jiangsu Province from 2015-2020. The Quartile of Reff in Jiangsu Province from 2015 to 2020 was 1.54 (0.49, 2.50). Rugao District and Jianhu District had the highest transmissibility according to the rank-sum ratio. Reff generally decreased in 2017 and increased in 2018 in most counties, and the median level of Reff was the lowest in 2017 (P < 0.05). The transmissibility was different in 97 counties in Jiangsu Province. The reasons for the differences may be related to the climate, demographic characteristics, virus subtypes, vaccination, hygiene and other infectious diseases.
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Doença de Mão, Pé e Boca , China/epidemiologia , Clima , Análise por Conglomerados , Doença de Mão, Pé e Boca/epidemiologia , Humanos , IncidênciaRESUMO
The specific antibodies induced by SARS-CoV-2 infection may provide protection against a subsequent infection. However, the efficacy and duration of protection provided by naturally acquired immunity against subsequent SARS-CoV-2 infection remain controversial. We systematically searched for the literature describing COVID-19 reinfection published before 07 February 2022. The outcomes were the pooled incidence rate ratio (IRR) for estimating the risk of subsequent infection. The Newcastle-Ottawa Scale (NOS) was used to assess the quality of the included studies. Statistical analyses were conducted using the R programming language 4.0.2. We identified 19 eligible studies including more than 3.5 million individuals without the history of COVID-19 vaccination. The efficacy of naturally acquired antibodies against reinfection was estimated at 84% (pooled IRR = 0.16, 95% CI: 0.14-0.18), with higher efficacy against symptomatic COVID-19 cases (pooled IRR = 0.09, 95% CI = 0.07-0.12) than asymptomatic infection (pooled IRR = 0.28, 95% CI = 0.14-0.54). In the subgroup analyses, the pooled IRRs of COVID-19 infection in health care workers (HCWs) and the general population were 0.22 (95% CI = 0.16-0.31) and 0.14 (95% CI = 0.12-0.17), respectively, with a significant difference (P = 0.02), and those in older (over 60 years) and younger (under 60 years) populations were 0.26 (95% CI = 0.15-0.48) and 0.16 (95% CI = 0.14-0.19), respectively. The risk of subsequent infection in the seropositive population appeared to increase slowly over time. In conclusion, naturally acquired antibodies against SARS-CoV-2 can significantly reduce the risk of subsequent infection, with a protection efficacy of 84%.Registration number: CRD42021286222.