RESUMEN
T follicular helper (TFH) cells, a critical subset of CD4+ T cells, provide help to B cells during the procession of the humoral immune response in the germinal center (GC) and extrafollicular sites. CXCR5+ CD4+ T cells in human circulating blood, referred to herein as peripheral TFH (pTFH) cells, share phenotypes and functional properties with TFH cells in GC. Hepatitis B vaccine protects about 60% of the chronic hepatitis C patients from hepatitis B. The immunological bases that lead to the induction of protective antibody response is not well understood. In the present study, the pTFH cells subsets were determined in 18 healthy controls (anti-HBs ≥ 100 mIU/mL; HC), 21 nonresponders (anti-HBs < 10 mIU/mL; NR), and 23 weak responders (10 mIU/mL ≤ anti-HBs < 100 mIU/mL; WR) of chronic hepatitis patients upon routine hepatitis B vaccination. Though the frequency of the pTFH cell was equivalent in HC, WR, and NR, ICOS+ pTFH cells in HC underwent expansion with increased IL-21 secretion and production of serum anti-HBs response at 4 weeks after a full course of hepatitis B vaccination. These changes were not shown in both NR and WR. Analysis of ICOS+ pTFH cells represents a novel cellular determinant of the hepatitis B vaccine-induced humoral immune response, which may have relevance for design of hepatitis B vaccine.
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Formación de Anticuerpos , Vacunas contra Hepatitis B/inmunología , Hepatitis B/inmunología , Proteína Coestimuladora de Linfocitos T Inducibles/sangre , Células T Auxiliares Foliculares/inmunología , Adulto , Anciano , Citocinas/sangre , Femenino , Hepatitis B/prevención & control , Anticuerpos contra la Hepatitis B/sangre , Humanos , Inmunidad Humoral , Interleucinas/sangre , Masculino , Persona de Mediana Edad , VacunaciónRESUMEN
Severe fever with thrombocytopenia syndrome (SFTS) was firstly discovered in China in 2010, followed by several reports from many other countries worldwide. SFTS virus (SFTSV) has been identified as the causative agent of the disease and has been recognized as a public health threat. This novel Bunyavirus belongs to the Phlebovirus genus in the family Bunyaviridae. This review also describes the different aspects of virology, pathogenesis, epidemiology, and clinical symptoms on the basis of the published article surveillance data and phylogenetic analyses of viral sequences of large, medium, and small segments retrieved from database using mega 5.05, simplot 3.5.1, network 4.611, and epi information system 3.5.3 software. SFTS presents with fever, thrombocytopenia, leukocytopenia, and considerable changes in several serum biomarkers. The disease has 10~15% mortality rate, commonly because of multiorgan dysfunction. SFTSV is mainly reported in the rural areas of Central and North-Eastern China, with seasonal occurrence from May to September, mainly targeting those of ≥50 years of age. A wide range of domesticated animals, including sheep, goats, cattle, pigs, dogs, and chickens have been proven seropositive for SFTSV. Ticks, especially Haemaphysalis longicornis, are suspected to be the potential vector, which have a broad animal host range in the world. More studies are needed to elucidate the vector-animal-human ecological cycle, the pathogenic mechanisms in high level animal models and vaccine development.
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Fiebres Hemorrágicas Virales/epidemiología , Fiebres Hemorrágicas Virales/virología , Orthobunyavirus/aislamiento & purificación , Trombocitopenia/etiología , Factores de Edad , Animales , China/epidemiología , Reservorios de Enfermedades , Vectores de Enfermedades , Fiebres Hemorrágicas Virales/patología , Humanos , Orthobunyavirus/clasificación , Orthobunyavirus/genética , Filogenia , Estaciones del Año , Análisis de Supervivencia , Topografía MédicaRESUMEN
Tick species distribution and prevalence of spotted fever group Rickettsiae (SFGR) in ticks were investigated in Zhejiang Province, China in 2010 and 2011. PCR was used to detect SFGR and positive amplicons were sequenced, compared to published sequences and phylogenic analysis was performed using MEGA 4.0. A total of 292 adult ticks of ten species were captured and 7.5 % (22/292) of the ticks were PCR-positive for SFG Rickettsia. The PCR-positive rates were 5.5 % (6/110) for Haemaphysalis longicornis, 3.6 % (1/28) for Amblyomma testudinarium and 16 % (15/94) for Ixodes sinensis, respectively. Phylogenetic analyses of gltA genes detected in ticks indicated that there are two dominating groups of SFGR. Sequences of group one were closely related to Rickettsia monacensis, whereas sequences of group two were closest related to Rickettsia heilongjiangensis and Rickettsia japonica, which are human pathogens. Our findings underline the importance of these ticks in public health surveillance in Zhejiang Province, China.
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Rickettsia/aislamiento & purificación , Garrapatas/microbiología , Animales , China , Filogenia , Rickettsia/genéticaRESUMEN
In June 2013, a subclinical infection with severe fever with thrombocytopenia syndrome virus (SFTSV) was detected in Zhejiang Province, China, prompting seroprevalence studies in 6 districts within the province. Of 986 healthy persons tested, 71 had IgG antibodies against SFTSV. This finding suggests that most natural infections with SFTSV are mild or subclinical.
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Anticuerpos Antivirales/inmunología , Voluntarios Sanos , Phlebovirus/inmunología , Vigilancia en Salud Pública , Anticuerpos Antivirales/sangre , China/epidemiología , Resultado Fatal , Humanos , Inmunoglobulina G/sangre , Inmunoglobulina G/inmunología , Masculino , Persona de Mediana Edad , Fiebre por Flebótomos/virología , Estudios SeroepidemiológicosRESUMEN
Enteroviruses are responsible for hand, foot, and mouth disease, and have caused many deaths in China during recent years. But the natural history of enterovirus infection in children, especially asymptomatic children, is not yet clear. From April 2011 to May 2012, 505 stool and throat swab samples of children attending outpatients clinics in two hospitals were collected weekly to test for Enterovirus 71, Coxsackievirus A16, and other enterovirus nucleic acids by real-time RT-PCR. Two hundred sixty-four patients were enterovirus positive, the positive rate was 52.3%, 27.5% (22/80) in children without a rash and 56.9% (242/425) in children with a rash. Coxsackievirus A16 positive rate of male (24%, 61/254) was higher than that of female (15.2%, 26/171) (χ(2) = 4.87, P = 0.027). The highest positive rate of enterovirus infection was 63.5% in the 2-year-old age group. Comparing children with and without a rash, within the same age groups, no statistical difference was found (P > 0.05). The seasonal distribution of Enterovirus 71 had only one peak in May, but Coxsackievirus A16 had two peaks in April and October. In patients with a rash, the frequency of Enterovirus 71 was relatively high before July, and then that of Coxsackievirus A16 increased gradually. In the case of Enterovirus 71 and Coxsackievirus A16, stool specimens had a higher positive rate than throat swab specimens' (χ(2) = 3.88, P = 0.05; χ(2) = 15.13, P < 0.001). Enterovirus infection was more frequent in males 2-3 year-old children, with the implicated virus varying by season. Targeted prevention and control measures should be carried out.
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Infecciones por Enterovirus/epidemiología , Distribución por Edad , Instituciones de Atención Ambulatoria , Niño , Preescolar , China/epidemiología , Femenino , Humanos , Lactante , Recién Nacido , Masculino , Estudios Prospectivos , Estaciones del Año , Distribución por SexoRESUMEN
BACKGROUND: A novel influenza A virus infection was identified on March 31, 2013 in China and a total of 134 cases were identified in 12 provinces of China between March 25 and September 31, 2013. Of these, 46 cases occurred in Zhejiang Province and the number of patients is the largest in China. METHODS: Field investigations were conducted for each confirmed H7N9 case. A standardized questionnaire was used to collect information about demographics, exposure history, clinical signs and symptoms, timelines of medical visits and care after onset of illness, and close contacts. Descriptive statistics were used to analyze the epidemiological and clinical characteristics. Samples from the patients were collected and tested by real time reverse transcriptase-polymerase chain reaction and viral culture. RESULTS: A total of 46 laboratory confirmed cases of H7N9 influenza infection were identified in the Zhejiang province between March 31 and September 31, 2013 of which 29 were male and 17 were female. The median age of patients was 61.5 years and 76.09% of cases occurred in persons aged ≥50 years old. Unlike other province, 34.78% of cases in Zhejiang Province were rural residents. Among 11 deaths, 9 were male, 10 were older than 60 years old, and 10 had underlying diseases. 30 of 38 cases with available data had a recent history of poultry exposures and 8 cases had multi-exposure history. The estimated median incubation period was two days which was shorter than corresponding data in other provinces. All cases were hospitalized and the median time from illness onset to hospitalization was 5 days. Symptoms at the onset of the illness included fever, cough, expectoration, shivering, fatigue, muscular aches, nausea, vomiting. Only 4.91% contacts developed respiratory symptoms, but their samples were tested negative for H7N9 virus designating lack of human-to-human transmission of the virus. CONCLUSIONS: All cases were sporadic and there was no evidence of an epidemiologic link between them. Control measures including closing affected poultry and slaughtering backyard poultry are needed not only in urban areas but also in rural areas to reduce human H7N9 infection risk.
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Enfermedades Transmisibles Emergentes/epidemiología , Brotes de Enfermedades , Subtipo H7N9 del Virus de la Influenza A/aislamiento & purificación , Gripe Humana/epidemiología , Adulto , Anciano , Anciano de 80 o más Años , Animales , China/epidemiología , Tos/virología , Femenino , Hospitalización , Humanos , Gripe Humana/virología , Masculino , Persona de Mediana Edad , Reacción en Cadena en Tiempo Real de la Polimerasa , Reacción en Cadena de la Polimerasa de Transcriptasa InversaRESUMEN
During April 2013 in China, mild respiratory symptoms developed in 1/61 workers who had culled influenza A(H7N9) virus-infected poultry. Laboratory testing confirmed A(H7N9) infection in the worker and showed that the virus persisted longer in sputum than pharyngeal swab samples. Pharyngeal swab samples from the other workers were negative for A(H7N9) virus.
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Subtipo H7N9 del Virus de la Influenza A , Gripe Humana/diagnóstico , Gripe Humana/virología , Adulto , Agricultura , Animales , China , Humanos , Subtipo H7N9 del Virus de la Influenza A/clasificación , Subtipo H7N9 del Virus de la Influenza A/genética , Subtipo H7N9 del Virus de la Influenza A/aislamiento & purificación , Gripe Aviar/transmisión , Gripe Humana/tratamiento farmacológico , Gripe Humana/transmisión , Masculino , Aves de CorralRESUMEN
Two RV vaccines have been licensed in Zhejiang province, China, including the pentavalent RotaTeq (RV5) and the monovalent RV vaccine (RV1). This study aimed to evaluate the cost-effectiveness of RV1 and RV5 to inform the prioritization of provincial immunization program. A decision tree-Markov model was applied to assess the cost-effectiveness of RV1 or RV5 vaccination, compared to no RV vaccination in a 5-year period. The incremental health cost per disability-adjusted life year (DALY) is averted when each kind of RV vaccine included in the immunization program was estimated. It was also compared to the willingness-to-pay (WTP) threshold of 1 time of the Gross Domestic Product (GDP) per capita of Zhejiang province in 2021 (16865.70US$). The uncertainties of these results were assessed through the one-way sensitivity analysis and probabilistic sensitivity analysis. In the base-case scenario, RV5 was the least costly RV vaccine with a cost-effectiveness ratio of 510 US$ per DALY averted. The other RV1 vaccines provided equivalent benefits but at higher costs, with a cost-effectiveness ratio of 4600 US$ per DALY averted. Compared to no vaccination, the probabilities of being cost-effective were 72.3% for RV1 and 88.4% for RV5, at a WTP threshold of 1 time of the GDP per capita. An RV vaccination program using any of the two China-licensed RV vaccines compared to no vaccination would avert 30-70% of outpatient visits, hospitalizations, and deaths from RVGE. RV5 was currently estimated to be the most cost-effective.
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Infecciones por Rotavirus , Vacunas contra Rotavirus , Humanos , Lactante , Infecciones por Rotavirus/prevención & control , Análisis de Costo-Efectividad , Análisis Costo-Beneficio , Programas de Inmunización , China , Árboles de DecisiónRESUMEN
Introduction: China experienced a record surge of coronavirus disease 2019 cases in December 2022, during the pandemic. Methods: We conducted a randomized, parallel-controlled prospective cohort study to evaluate efficacy and antibody duration after a fourth-dose booster with Ad5-nCoV or inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine. Results: A total of 191 participants aged ≥18 years who had completed a three-dose regimen of the inactivated SARS-CoV-2 vaccine 6 months earlier were recruited to receive the intramuscular Ad5-nCoV booster or the inactivated SARS-CoV-2 vaccine. The Ad5-nCoV group had significantly higher antibody levels compared with the inactivated vaccine group at 6 months after the fourth vaccination dose. After the pandemic, the breakthrough infection rate for the Ad5-nCoV and the inactivated vaccine groups was 77.89% and 78.13%, respectively. Survival curve analysis (p = 0.872) and multivariable logistic regression analysis (p = 0.956) showed no statistically significant differences in breakthrough infection between the two groups. Discussion: Compared with a homologous fourth dose, a heterologous fourth dose of Ad5-nCoV elicited a higher immunogenic response in healthy adults who had been immunized with three doses of inactivated vaccine. Nevertheless, the efficacy of the two vaccine types was equivalent after the pandemic.
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Infección Irruptiva , Vacunas contra la COVID-19 , COVID-19 , Adolescente , Adulto , Humanos , Anticuerpos/inmunología , Infección Irruptiva/epidemiología , Infección Irruptiva/inmunología , Infección Irruptiva/prevención & control , COVID-19/inmunología , COVID-19/prevención & control , Vacunas contra la COVID-19/inmunología , Vacunas contra la COVID-19/uso terapéutico , Pueblos del Este de Asia , Estudios Prospectivos , SARS-CoV-2 , Vacunas de Productos Inactivados/inmunología , Vacunas de Productos Inactivados/uso terapéutico , Eficacia de las Vacunas , Inmunización Secundaria , Anticuerpos Antivirales/inmunología , China/epidemiología , Pandemias/estadística & datos numéricos , Brotes de Enfermedades/estadística & datos numéricosRESUMEN
BACKGROUND: Because SARS-CoV-2 mutations and immunity wane over time, a third dose of heterologous COVID-19 vaccine is proposed for individuals primed with inactivated COVID-19 vaccine. RESEARCH DESIGN AND METHODS: We conducted a single-center, open-label trial to assess the safety, immunogenicity, and immune-persistence of a heterologous BBIBP-CorV/ZF2001 prime-boost vaccination in Chinese adults. 480 participants who had been primed with two doses of BBIBP-CorV, received a third dose of ZF2001 after an interval of 3-4, 5-6, or 7-9 months. RESULTS: The overall incidence of adverse reactions within 30 days after vaccination was 5.83%. No serious adverse reactions were reported. The respective geometric mean titers (GMTs) of neutralizing antibodies for 3-4, 5-6, and 7-9 months groups at baseline were 2.06, 2.02, and 2.10; which increased to 55.42, 63.45, and 62.06 on day 14; then decreased to 17.53, 23.79, and 26.73 on day 30; before finally waning to 8.29, 9.24, and 9.51 on day 180. After the booster, the three groups showed no significant differences in GMTs. GMTs were lower in older participants than younger participants. CONCLUSIONS: A heterologous BBIBP-CorV/ZF2001 prime-boost vaccination was safe and immunogenic. Prime-boost intervals did not affect the immune response. The immune response was weaker in older adults than younger adults. CLINICAL TRIAL IDENTIFIER: NCT05205083.
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Vacunas contra la COVID-19 , COVID-19 , Anciano , Humanos , Anticuerpos Neutralizantes , Anticuerpos Antivirales , COVID-19/prevención & control , Vacunas contra la COVID-19/efectos adversos , Inmunización , Inmunogenicidad Vacunal , SARS-CoV-2 , VacunaciónRESUMEN
Data on the safety and immunity of a heterologous booster (fourth dose) after three-doses of inactivated SARS-CoV-2 vaccine in Chinese adults are limited. We evaluate the safety and immunogenicity of Ad5-nCoV in a randomized, double-blind, parallel-controlled phase 4 clinical trial in Zhejiang, China (NCT05373030). Participants aged 18-80 years (100 per group), administered three doses of inactivated SARS-CoV-2 vaccine ≥6 months earlier, are enrolled and randomized 1:1 into two groups, which are administered intramuscular Ad5-nCoV or inactivated SARS-CoV-2 vaccine (CoronaVac or Covilo). All observed adverse reactions are predictable and manageable. Ad5-nCoV elicits significantly higher RBD-specific IgG levels, with a geometric mean concentration of 2924.0 on day 14 post-booster, 7.8-fold that of the inactivated vaccine. Pseudovirus-neutralizing antibodies to Omicron BA.4/5 show a similar pattern, with geometric mean titers of 228.9 in Ad5-nCoV group and 65.5 in inactivated vaccine group. Ad5-nCoV booster maintains high antibody levels on day 90, with seroconversion of 71.4%, while that of inactivated vaccine is 5.2%, almost pre-booster levels. A fourth Ad5-nCoV vaccination following three-doses of inactivated SARS-CoV-2 vaccine is immunogenic, tolerable, and more efficient than inactivated SARS-CoV-2 vaccine. Ad5-nCoV elicits a stronger humoral response against Omicron BA.4/5 and maintains antibody levels for longer than homologous boosting.
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Vacunas contra la COVID-19 , COVID-19 , Adulto , Humanos , Anticuerpos Neutralizantes , Anticuerpos Antivirales , COVID-19/prevención & control , Vacunas contra la COVID-19/administración & dosificación , Vacunas contra la COVID-19/inmunología , Pueblos del Este de Asia , SARS-CoV-2 , Vacunación , Vacunas de Productos Inactivados/administración & dosificación , Vacunas de Productos Inactivados/inmunología , Adulto Joven , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Inmunogenicidad VacunalRESUMEN
Background: Although inactivated COVID-19 vaccines are proven to be safe and effective in the general population, the dynamic response and duration of antibodies after vaccination in the real world should be further assessed. Methods: We enrolled 1067 volunteers who had been vaccinated with one or two doses of CoronaVac in Zhejiang Province, China. Another 90 healthy adults without previous vaccinations were recruited and vaccinated with three doses of CoronaVac, 28 days and 6 months apart. Serum samples were collected from multiple timepoints and analyzed for specific IgM/IgG and neutralizing antibodies (NAbs) for immunogenicity evaluation. Antibody responses to the Delta and Omicron variants were measured by pseudovirus-based neutralization tests. Results: Our results revealed that binding antibody IgM peaked 14-28 days after one dose of CoronaVac, while IgG and NAbs peaked approximately 1 month after the second dose then declined slightly over time. Antibody responses had waned by month 6 after vaccination and became undetectable in the majority of individuals at 12 months. Levels of NAbs to live SARS-CoV-2 were correlated with anti-SARS-CoV-2 IgG and NAbs to pseudovirus, but not IgM. Homologous booster around 6 months after primary vaccination activated anamnestic immunity and raised NAbs 25.5-fold. The neutralized fraction subsequently rose to 36.0% for Delta (p=0.03) and 4.3% for Omicron (p=0.004), and the response rate for Omicron rose from 7.9% (7/89)-17.8% (16/90). Conclusions: Two doses of CoronaVac vaccine resulted in limited protection over a short duration. The inactivated vaccine booster can reverse the decrease of antibody levels to prime strain, but it does not elicit potent neutralization against Omicron; therefore, the optimization of booster procedures is vital. Funding: Key Research and Development Program of Zhejiang Province; Key Program of Health Commission of Zhejiang Province/ Science Foundation of National Health Commission; Major Program of Zhejiang Municipal Natural Science Foundation; Explorer Program of Zhejiang Municipal Natural Science Foundation.
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Vacunas contra la COVID-19 , COVID-19 , Adulto , Humanos , Estudios de Cohortes , Estudios Transversales , COVID-19/prevención & control , SARS-CoV-2 , Anticuerpos Neutralizantes , Inmunoglobulina G , Anticuerpos Antivirales , ChinaRESUMEN
New vaccines are being developed in response to the coronavirus disease 2019 (COVID-19) pandemic. Vaccination provides a crucial preventive approach for managing COVID-19. We investigated adults' willingness to take COVID-19 vaccines in the Zhejiang province, and their cognitions regarding COVID-19, when the COVID-19 vaccine is authorized under Emergency Use Administration. An online survey was conducted from September to October 2020, which included social-demographic characteristics, risk perception, acceptance and influencing factors in relation to COVID-19 vaccines. Multivariate logistic regression was performed to identify the influencing factors of vaccination acceptance. Of the participants, 70% intended to be vaccinated when the COVID-19 vaccine was approved under Emergency Use Administration, among 2171 valid questionnaires. Logistic regression revealed that being male, having a high cognitive score regarding COVID-19, the belief that the COVID-19 vaccine is safe and effective, and the belief that one will be infected with SARS-CoV-2 this fall and winter, were associated with a greater probability of accepting vaccination. Respondents with junior college/university education or above were less likely to accept vaccination. Concerns about the safety and effectiveness of the vaccine were the main factors hindering vaccination acceptance. Health education is important for promoting accurate public knowledge regarding COVID-19 vaccination.
RESUMEN
OBJECTIVES: A cross-sectional survey was conducted among healthcare workers (HCWs) to assess their knowledge, attitude, and reporting behavior in adverse event following immunization (AEFI) surveillance as well as to identify barriers. METHODS: A simple random sample of 170 vaccination clinics was selected and one HCW was informed to participate in this survey in each selected vaccination clinic. The survey was developed using a secure online platform and consisted of a structured online questionnaire. The distributions of the respondents' characteristics were presented. Training status, knowledge, attitude, and reporting behavior were compared between sub-groups of HCWs. Barriers and suggestions on AEFI reporting were also summarized. RESULTS: Of the 170 surveyed HCWs, 61.76% received the training on AEFI surveillance while 15.88% had no AEFI training at all. The higher level of knowledge and the more positive attitude and reporting behavior on AEFI surveillance were observed among HCWs with the longer working duration on AEFI surveillance, or among HCWs who received the training. The most critical barrier to reporting an AEFI was 'not being sure if the AEFI is related to the vaccine' (122, 71.76%). Other barriers were: 'I do not want to raise unnecessary public alarm about a vaccine' (105, 61.76%); 'reporting form or other method being too complicated' (65, 38.23%). CONCLUSION: The study findings highlighted the need to prioritize training on AEFI surveillance for HCWs. It is recommended that the development of the targeted interventions to strengthen AEFI surveillance system be required based on the barriers found in this study.
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Sistemas de Registro de Reacción Adversa a Medicamentos , Vacunas , Humanos , Estudios Transversales , Inmunización/efectos adversos , Vacunación/efectos adversos , Vacunas/efectos adversos , Personal de Salud , China , Accesibilidad a los Servicios de SaludRESUMEN
Background: The COVID-19 pandemic is striking the world with serious public health and economic losses. Complying with precautionary measures is affected by knowledge, attitudes, and practices (KAP) toward COVID-19 among the general public, so it is urgent to know the public's awareness of COVID-19 as to promote the epidemic management of COVID-19 in China. Methods: An online sample of Chinese residents was recruited. We administered a self-developed online KAP survey comprising 39 questions regarding awareness of COVID-19, transmission mode, symptoms, preventive measures, and respondents' attitudes and practices with respect to COVID-19. The total score of each item (knowledge, attitudes, and practices) adopts the ten points system, score of KAP is 30 points. Descriptive statistics, analysis of variance, and binomial logistic regression were used in the statistical analysis. Results: Among respondents, average scores for COVID-19-related knowledge, attitudes, and practice were 8.94 ± 0.79, 5.97 ± 1.58, and 7.03 ± 3.14, respectively. 91.2% were aware that COVID-19 is an acute viral infection and 99.95% knew that wearing a mask is one way to prevent COVID-19 infection. Participants correctly identified the symptoms of COVID-19 with a high accuracy rate of over 85%. Conclusion: Many adults in the present study had adequate knowledge, a positive attitude and engaged in correct practices against COVID-19. People in China have a high awareness of epidemic prevention and control. However, conducting KAP surveys among people with different demographic characteristics at different stages of the epidemic is important to improve public health education and implement proper COVID-19 prevention and control measures.
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COVID-19 , Adulto , COVID-19/epidemiología , COVID-19/prevención & control , China/epidemiología , Estudios Transversales , Conocimientos, Actitudes y Práctica en Salud , Humanos , Pandemias/prevención & controlRESUMEN
The safety profile of the 9-valent human papillomavirus vaccine (9vHPV) was evaluated based on the reporting rate of adverse events following immunization (AEFI) obtained from the passive surveillance data in Zhejiang. The 9vHPV AEFI reports in Zhejiang were collected and reviewed from the National Adverse Event Following Immunization Surveillance System (NAEFISS) from 2019 to 2021. Reporting rates of AEFI were analyzed under multiple aspects, including age, city, number of vaccinations, AEFI categories, and diagnosis categories. This study used the reporting odds ratio (ROR) for anomalous signal assessment. The NAEFISS collected 331 AEFI reports after administering 1,064,851 doses of 9vHPV, with a crude AEFI rate of 3.12/10,000 doses. The third dose had the highest reporting rate of minor vaccine-related reaction (n = 80, 3.06 per 10,000), followed by the first dose (n = 134, 2.98 per 10,000), and second dose (n = 76, 2.15 per 10,000). Fever/redness/induration was the most common minor adverse event (281 records, 2.64/10,000 doses). Nine cases of urticaria, ten cases of allergic rash, and ten cases of syncope were recorded. This study found a positive signal association between 9vHPV immunization and adverse events such as syncope, encephalitis, sterile abscess, and urticaria. This study did not identify any new emerging safety concerns. In the future, more research is needed to validate and further explore adverse reactions associated with 9vHPV.
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Vacunas contra Papillomavirus , Urticaria , Humanos , Lactante , Vacunas contra Papillomavirus/efectos adversos , Virus del Papiloma Humano , Sistemas de Registro de Reacción Adversa a Medicamentos , Vacunación/efectos adversos , Inmunización/efectos adversos , Urticaria/inducido químicamente , Síncope/inducido químicamente , ChinaRESUMEN
OBJECTIVES: To evaluate the safety of 13-valent pneumococcal conjugate vaccine (PCV13) after its licensure. METHODS: Review and describe the AEFI reported to national adverse event following immunization surveillance system (NAEFISS) in Zhejiang province from 2017 to 2020. Reporting rates of AEFI were calculated by age, city, severity of AEFI, categories of AEFI, and reaction categories. The data mining algorithm used in this study was reporting odds ratio (ROR). A value of ROR-1.96SE >1 (standard error [SE]) was considered as the positive signal. RESULTS: NAEFISS received 3332 AEFI cases following PCV13, with a reporting rate of 17.58/10000 doses. Of the reported AEFI, 652 were serious AEFI cases and the reporting rate was 3.44 for serious AEFI. The reporting rate of fever was the highest among all the clinical diagnosis (7.39/10000 doses). The positive signals were obtained for injection site reaction (ROR-1.96SE: 1.55), hypotonic hyporesponsive episode (HHE) (ROR-1.96SE: 1.62) and febrile seizure (ROR-1.96SE: 1.52). CONCLUSION: The present results supported previous observations that the PCV13 administered as the four-dose schedule was generally well tolerated in Chinese infants as we did not identify any new/unexpected safety concern from the NAEFISS during a four-year time period.
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Inmunización , Vacunación , Sistemas de Registro de Reacción Adversa a Medicamentos , China/epidemiología , Humanos , Inmunización/efectos adversos , Lactante , Vacunación/efectos adversos , Vacunas ConjugadasRESUMEN
Yearly administration of influenza vaccine with recommendations can help control seasonal influenza epidemics in adults aged ≥60 years. Here, we describe the results of a prospective study observing the immunogenicity and persistence of induced immunity of a trivalent inactivated split-virion influenza vaccine (TIV) in adults aged ≥60 years during the 2018-2019 season in Taizhou City, Zhejiang Province in China. A total of 422 participants completed the study period. Vaccinated participants (284) received a single dose of TIV, but unvaccinated participants (138) didn't receive any vaccine. Study participants vaccinated with TIV had significantly higher GMTs of Hemagglutination Inhibition (HI) antibodies against AH1N1, AH2N3, and B/Victoria strains (all p < .0001) at day 30 post-vaccination compared with unvaccinated participants, but the antibody response to the B/Victoria strain was the weakest. Rates of seroprotection and seroconversion were generally higher in the TIV-vaccinated group. At day 180 post-vaccination, the seroconversion rates (95%CI) in the vaccinated group were 99.6% (99.0%-100.3%), 97.9% (96.2%-99.6%), and 68.3% (62.9%-73.8%) for antibodies against three influenza strains, respectively; these rates were significantly different compared with unvaccinated group only for strains AH3N2 and B/Victoria (p = .002 and p < .0001, respectively). These results confirm that in adults aged ≥60 years, a single dose of TIV can induce a protective immune response against influenza, but the protective HI antibody levels induced against strain B/Victoria do not persist through 6 months.
Asunto(s)
Vacunas contra la Influenza , Gripe Humana , Adulto , Anticuerpos Antivirales , China , Humanos , Gripe Humana/prevención & control , Estudios Prospectivos , Estaciones del Año , Vacunas de Productos InactivadosRESUMEN
OBJECTIVES: One dose of Sabin-strains inactivated polio vaccine (IPV) was introduced into the Chinese immunization program on 1 May 2016. This study aimed to evaluate the safety of Sabin-strains IPV and provide a comparison with conventional Salk-strains IPV. METHODS: Adverse events following immunization (AEFI) records associated with Sabin-strains IPV and Salk-strains IPV were extracted from the national AEFI surveillance system (NAEFISS) from 1 May 2016 to 31 December 2020. The vaccination information on Sabin-strains IPV and Salk-strains IPV during the same period was obtained from the Zhejiang provincial immunization information system. Reporting rates of AEFI were calculated by age, city, severity of AEFI, categories of AEFI, and reaction categories and were compared between Sabin-strains IPV and Salk-strains IPV. RESULTS: In total, 3,861,758 doses of Sabin-strains IPV and 1,018,604 doses of Salk-strains IPV were administered during the study period. The overall AEFI reporting rate for Sabin-strains IPV (3.96/10,000 doses) was significantly lower than that for Salk-strains IPV (5.03/10,000 doses) due to the reporting rate of the minor vaccine product-related reaction following Sabin-strains IPV was significantly lower than that for Salk-strains IPV (2.76/10,000 doses vs. 3.83/10,000 doses). The most frequently reported symptoms/signs were fever, induration/swelling, and rash/urticaria. The most frequently reported serious AEFI with a causal relationship was febrile convulsion, with the reporting rates of 0.10/10,000 doses for Sabin-strains IPV and 0.08/10,000 doses for Salk-strains IPV. No significant difference was found in the reporting rates of the other serious AEFI between the two types of IPV. CONCLUSION: Most of the AEFI following Sabin-strains IPV and Salk-strains IPV were mild and common adverse reactions. The reporting rate of serious AEFI was not significantly different between Sabin-strains IPV and Salk-strains IPV. Sabin-strains IPV had a favorable safety profile and could be widely used.
RESUMEN
OBJECTIVES: The aim of this study is to describe the reporting rate of adverse events following immunization (AEFI) with pentavalent vaccine: diphtheria-pertussis-tetanus-poliomyelitis-Haemophilus influenzae type b (DPT-IPV/Hib), and to determine whether the reporting rate of AEFI following DPT-IPV/Hib was higher than the average level of the other vaccines. METHODS: Review and describe the AEFI reported to national adverse event following immunization surveillance system (NAEFISS) in Zhejiang province from 2015 to 2020. Reporting rates of AEFI were calculated by age, city, severity of AEFI, categories of AEFI, and reaction categories. The data mining algorithm used in this study was reporting odds ratio (ROR). A value of ROR1.96SE >1 (standard error [SE]) was considered as positive signal. RESULTS: NAEFISS received 5726 AEFI reports following DTP-IPV/Hib, with a reporting rate of 20.01/10000 doses. Of the reported AEFI, 202 were serious vaccine product-related reactions, including two cases of anaphylactic shock, five cases of Guillain Barre Syndrome (GBS) and two cases of acute disseminated encephalomyelitis. The reporting rate of fever/redness/induration was the highest among all the clinical diagnosis (14.97/10000 doses). The positive signals were obtained for allergic rash (ROR-1.96SE: 1.36), febrile convulsion (ROR-1.96SE: 1.32) and GBS (ROR-1.96SE: 1.16). CONCLUSION: The present findings bolstered that the DTP-IPV/Hib administered as the four-dose schedule was generally well tolerated in Chinese infants as we did not identify any new/unexpected safety concern from the NAEFISS during a six-year timespan.