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1.
Hum Vaccin Immunother ; : 1-9, 2019 Apr 04.
Artigo em Inglês | MEDLINE | ID: mdl-30945978

RESUMO

The Arthus reaction is a rare adverse reaction that usually occurs after vaccination with large and more severe local reactions, belonging to type Ⅲ hypersensitivity reaction. This reaction is characterized by pain, swelling, induration (Tissue that becomes firm) and edema, even accompanied by severe necrosis or ulceration at the injection sites. However, most of mild cases generally can be cured without treatment, and only severe cases need to be treated with anti-allergy. Therefore, this adverse reaction is often ignored by people. We searched PubMed, Web of Science and Chinese database (CNKI database and Wan Fang database) for published studies using the terms "Arthus reaction" or "Arthus phenomenon", combined with "vaccine", with no date or language restrictions for all publications before January 28, 2019. Only 30 cases of Arthus reaction were found, of which only one case died.4 cases of Arthus reaction post-dose-1 were reported in the review. The proportion of Arthus reaction occurred after the first, second and third injections in those case reports was 13.3%, 50.0%, and 23.3%, respectively. Arthus reaction was determined according to the clinical symptoms (The symptoms which were observed by the researchers, such as red, swelling and painful with itching at or around the injection sites). The specific causes of Arthus reaction after one dose of vaccination are not described in detail in literatures. Therefore, it could be hypothesized that the case has a pre-existing specific IgG (Such as pre-existing antibody, etc.) to cause the Arthus reaction. And 17 reported cases were observed in children younger than 6 y. In addition, we collected only 18 cases of bacterial vaccine-induced Arthus reaction and 12 cases of viral vaccines. However, there are no other data (Such as the total number and incidence rate of vaccination) in literatures, so we cannot compare statistically significant differences. At presents, no previous reviews of vaccine-induced Arthus reaction have been found. Thus, a systematic review about vaccine-associated Arthus reaction is urgently needed to deepen people's understanding and concern of this phenomenon. In this manuscript, we retrospectively reviewed the description of the discovery process and mechanisms of Arthus reaction, a description of the characteristics of Arthus reaction cases, reporting the Arthus reaction cases in China during 2010-2015, diagnostic criteria and general treatment, preventive measures of Arthus reaction, and challenges remaining to be investigated in the future.

2.
Neurogastroenterol Motil ; : e13493, 2018 Oct 18.
Artigo em Inglês | MEDLINE | ID: mdl-30334342

RESUMO

BACKGROUND: Inflammatory bowel disease (IBD) is a functional disorder with chronic and relapsing clinical features. Vasopressin (VP) is a hormone responsible for water and stress homeostasis and also regulates gastrointestinal inflammation and motility. We explored whether VP was related to IBD pathogenesis and its possible pathway. METHODS: Colitis was induced by 2,4,6-trinitrobenzenesulfonic acid (TNBS) in mice. The disease activity and colonic damage were evaluated through a scoring system. Locations of the V1a receptor were revealed by immunochemistry method in colon. Ussing chamber technique was performed for the electrophysiological characterization by using rat ileum. The (Arg8 )-Vasopressin (AVP)-evoked short-circuit current (Isc) was recorded in the presence of conivaptan (V1a and V2 receptor antagonist), tolvaptan (V1b receptor antagonist), tetrodotoxin (TTX), atropine, cyclooxygenase (COX) inhibitors (indomethacin, nonspecific COX antagonist; SC560, COX-1 antagonist; NS560, COX-2 antagonist), and a stabilizer of mast cell (cromolyn sodium), respectively. KEY RESULTS: TNBS resulted in the obvious loss of body weight and tissue damages in mice. AVP significantly aggravated the TNBS-induced colitis, which was attenuated by conivaptan but not tolvaptan. V1a receptors were found immunopositive in neurons among the enteric nervous system. AVP evoked a pulsatile response in Isc. Its amplitude, frequency, and cycle duration were around 8-15 µA/cm2 , 10-11 mHz, and 1.5 minutes, respectively. Notably, the AVP-evoked change in Isc was abolished by TTX, atropine, conivaptan, indomethacin, NS560, and cromolyn sodium, respectively. CONCLUSIONS AND INFERENCES: VP-V1a receptor played the proinflammatory role in TNBS-induced colitis by promoting COX-2-dependent prostaglandin release from mucosal mast cells, which was mediated by the cholinergic pathway.

3.
Ying Yong Sheng Tai Xue Bao ; 29(3): 987-996, 2018 Mar.
Artigo em Chinês | MEDLINE | ID: mdl-29722244

RESUMO

Quantitative evaluation of ecosystem service is a primary premise for rational resources exploitation and sustainable development. Examining ecosystem services flow provides a scientific method to quantity ecosystem services. We built an assessment indicator system based on land cover/land use under the framework of four types of ecosystem services. The types of ecosystem services flow were reclassified. Using entropy theory, disorder degree and developing trend of indicators and urban ecosystem were quantitatively assessed. Beijing was chosen as the study area, and twenty-four indicators were selected for evaluation. The results showed that the entropy value of Beijing urban ecosystem during 2004 to 2015 was 0.794 and the entropy flow was -0.024, suggesting a large disordered degree and near verge of non-health. The system got maximum values for three times, while the mean annual variation of the system entropy value increased gradually in three periods, indicating that human activities had negative effects on urban ecosystem. Entropy flow reached minimum value in 2007, implying the environmental quality was the best in 2007. The determination coefficient for the fitting function of total permanent population in Beijing and urban ecosystem entropy flow was 0.921, indicating that urban ecosystem health was highly correlated with total permanent population.


Assuntos
Conservação dos Recursos Naturais , Ecossistema , Entropia , Pequim , China , Cidades , Monitoramento Ambiental , Humanos
5.
Expert Rev Vaccines ; 17(3): 257-262, 2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-29363365

RESUMO

BACKGROUND: The Sinovac enterovirus 71 (EV71) vaccine has shown good safety, immunogenicity, and efficacy in infants aged 6-35 months, whom are considered as the priority of the target population. However, 3-5 years old children accounted for approximately 30% of HFMD cases and are also worth our attention. METHODS: A randomized, double-blind, placebo-controlled, batch-to-batch consistency clinical trial enrolling 1400 participants aged 6-59 months was performed. We pooled the participants receiving three batches of EV71 vaccine together and then stratified them into the 6-35 months and 3-5 years. The non-inferiority analysis of the geometric mean titer (GMT) of EV71 neutralizing antibody post-vaccination was the primary endpoint. RESULTS: In the vaccine group, the GMT of 242 children aged 3-5 years was 132.72 (95% CI, 110.3-159.6), which was non-inferior to that generated in 717 infants aged 6-35 months. Following the vaccination, the incidence of adverse reactions was less frequent in children aged 3-5 years (47.0%) than that found in infants aged 6-35 months (60.1%) (p = 0.0026). CONCLUSIONS: Our study indicated that the EV71 vaccine was also safe in children aged 3-5 years, with non-inferior immunogenicity to that in infants aged 6-35 months.


Assuntos
Anticorpos Neutralizantes/imunologia , Enterovirus Humano A/imunologia , Infecções por Enterovirus/prevenção & controle , Vacinas Virais/administração & dosagem , Fatores Etários , Pré-Escolar , Método Duplo-Cego , Infecções por Enterovirus/imunologia , Feminino , Humanos , Lactente , Masculino , Vacinas de Produtos Inativados , Vacinas Virais/efeitos adversos , Vacinas Virais/imunologia
6.
Expert Rev Vaccines ; 16(11): 1155-1169, 2017 11.
Artigo em Inglês | MEDLINE | ID: mdl-28870140

RESUMO

BACKGROUND: Viruses from two antigenically distinct influenza B strains have co-circulated since the mid-1980s, yet inactivated trivalent influenza vaccines (TIVs) with either the Victoria or Yamagata lineage could only provide limited protection from influenza B strain. Quadrivalent influenza vaccine (QIV) including both influenza B lineages can improve protection against circulating influenza B viruses. METHODS: Participants >/ = 3 years of age were recruited, stratified by age, and then randomly allocated at a ratio of 2:1:1 to receive one-injection of the experimental QIV, TIV-Victoria (Vic) or TIV-Yamagata (Yam). The primary objective of this study was to demonstrate that the hemagglutination-inhibition (HI) antibodies induced by the QIV candidate are not inferior to the licensed TIVs. RESULTS: First, 3661 participants received the inoculation. The QIV was found to be non-inferior to TIVs in terms of the geometric mean titers (GMTs) and seroconversion rates (SCRs) of the HI antibodies against shared strains 28 days after completion of inoculation, and was superior to the TIVs against the alternate B strain, which is absent from the TIVs. The occurrences of adverse events (AEs) post-vaccination were similar across the treatment groups. CONCLUSION: The experimental QIV showed good immunogenicity and an acceptable safety profile.


Assuntos
Vacinas contra Influenza/efeitos adversos , Vacinas contra Influenza/imunologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Anticorpos Antivirais/sangue , Criança , Pré-Escolar , China , Método Duplo-Cego , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Feminino , Testes de Inibição da Hemaglutinação , Humanos , Vacinas contra Influenza/administração & dosagem , Masculino , Pessoa de Meia-Idade , Soroconversão , Vacinas de Produtos Inativados/administração & dosagem , Vacinas de Produtos Inativados/efeitos adversos , Vacinas de Produtos Inativados/imunologia , Adulto Jovem
7.
Expert Rev Vaccines ; 16(9): 945-949, 2017 09.
Artigo em Inglês | MEDLINE | ID: mdl-28548626

RESUMO

BACKGROUND: Inactivated Enterovirus 71 (EV71) vaccines showed significant efficacy against the diseases associated with EV71 and a neutralizing antibody (NTAb) titer of 1:16-1:32 was suggested as the correlates of the vaccine protection. This paper aims to further estimate the immunological surrogate endpoints for the protection of inactivated EV71 vaccines and the effect factors. METHODS: Pre-vaccination NTAb against EV71 at baseline (day 0), post-vaccination NTAb against EV71 at day 56, and the occurrence of laboratory-confirmed EV71-associated diseases during a 24-months follow-up period were collected from a phase 3 efficacy trial of an inactivated EV71 vaccine. We used the mixed-scaled logit model and the absolute sigmoid function by some extensions in continuous models to estimate the immunological surrogate endpoint for the EV71 vaccine protection, respectively. RESULTS: For children with a negative baseline of EV71 NTAb titers, an antibody level of 26.6 U/ml (1:30) was estimated to provide at least a 50% protection for 12 months, and an antibody level of 36.2 U/ml (1:42) may be needed to achieve a 50% protective level of the population for 24 months. CONCLUSION: Both the pre-vaccination NTAb level and the vaccine protective period could affect the estimation of the immunological surrogate for EV71 vaccine. A post-vaccination NTAb titer of 1:42 or more may be needed for long-term protection. CLINICAL TRIAL REGISTRATION: NCT01508247.


Assuntos
Enterovirus Humano A/imunologia , Infecções por Enterovirus/prevenção & controle , Vacinas Virais/imunologia , Anticorpos Neutralizantes/sangue , Anticorpos Antivirais/sangue , Biomarcadores , Pré-Escolar , Método Duplo-Cego , Infecções por Enterovirus/virologia , Feminino , Humanos , Lactente , Masculino , Vacinas de Produtos Inativados/administração & dosagem , Vacinas de Produtos Inativados/imunologia , Vacinas Virais/administração & dosagem
8.
Expert Rev Vaccines ; 16(5): 515-524, 2017 May.
Artigo em Inglês | MEDLINE | ID: mdl-28277801

RESUMO

BACKGROUND: The objective of this study was to evaluate the immunogenicity and safety of the novel combined Haemophilus influenzae type b-Neisseria meningitidis serogroup A and C-tetanus toxoid conjugate vaccine (Hib-MenAC). METHODS: We conducted a non-inferiority, randomized, observer-blind, positive control clinical trial in 900 healthy infants aged between 3-5 months in Funing County, Jiangsu Province, China. Participants were randomly allocated, in a ratio of 2:1 (block = 6), to receive experimental combined Hib-MenAC vaccines co-administrated with placebo or the co-administration of licensed Hib vaccine and MenAC vaccine, according to a three-dose immunization schedule. The seroconversion of antibody titer against meningococcal serogroups A, C and Hib was the primary endpoint. RESULTS: The experimental vaccines was non-inferior to the licensed two control vaccines. Participants receiving experimental Hib-MenAC vaccines showed a seroconversion rate of 99.0%, 96.1% and 97.7% for rSBA-MenA, rSBA-MenC and anti-PRP antibodies, respectively. The Hib-MenAC vaccine did not result in an increase in adverse reaction, and no serious adverse event was judged to be related to the vaccination. CONCLUSIONS: The novel combined Hib-MenAC conjugate vaccine was safe and highly immunogenic in infants aged between 3 to 5 months.


Assuntos
Vacinas Anti-Haemophilus/imunologia , Vacinas Meningocócicas/efeitos adversos , Vacinas Meningocócicas/imunologia , Anticorpos Antibacterianos/sangue , China , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/patologia , Feminino , Vacinas Anti-Haemophilus/administração & dosagem , Haemophilus influenzae tipo b/imunologia , Humanos , Lactente , Masculino , Vacinas Meningocócicas/administração & dosagem , Neisseria meningitidis Sorogrupo A/imunologia , Neisseria meningitidis Sorogrupo C/imunologia , Placebos/administração & dosagem , Método Simples-Cego , Toxoide Tetânico/administração & dosagem , Toxoide Tetânico/efeitos adversos , Toxoide Tetânico/imunologia , Resultado do Tratamento , Vacinas Combinadas/administração & dosagem , Vacinas Combinadas/efeitos adversos , Vacinas Combinadas/imunologia , Vacinas Conjugadas/administração & dosagem , Vacinas Conjugadas/efeitos adversos , Vacinas Conjugadas/imunologia
9.
Hum Vaccin Immunother ; 13(4): 823-830, 2017 04 03.
Artigo em Inglês | MEDLINE | ID: mdl-27768527

RESUMO

Herpangina (HA) and hand, foot, and mouth disease (HFMD) are common infectious diseases caused by human enteroviruses and frequently occurr in young children. Previous published studies have mainly focused on HFMD, while the HA epidemiological and etiological characteristics in mainland China have not been described. From June, 2013 to March, 2014, HA and HFMD patients were monitored in participants from clinical trial of EV-A71 vaccine conducted during 2012-2013. A total of 95 HA patients and 161 HFMD patients were defined. Enteroviruses of HA samples were differentiated into 17 serotypes (EV-A71, CV-A16, CV-A24, E6, CV-B5, CV-A22, CV-A6, CV-A10, CV-B3, E9, CV-A9, CV-B4, CV-B2, E1, E7, E21 and CV-A20), the most common serotypes were EV-A71(10/95,10.5%), CV-A16(4/95,4.2%) and CV-A24(4/95,4.2%); while enteroviruses detected from HFMD samples were classfied into 21 serotypes ( EV-A71, CV-A16, CV-A10, CV-A6, E6, CV-B3, CV-B5, CV-A9, E9, CV-B2, CV-B4, E3, E11, E15, E16, CV-A1, EV-A69, E5, CA22, CA24 and EV99), the most common serotypes were EV-A71(28/161,17.4%), CV-A16(7/161,4.4%) and CV-A10(5/161,3.1%). The first HA epidemic peak occurred in summer and a second smaller peak occurred in January. In HA patients, the body temperature (P < 0.0001) and the incidence of fever (P < 0.05) were significant higher than those in HFMD patients. Between HA and HFMD patients infected with EV-A71, no significant differences were found in age, sex, circulating season, and the viral genome diversity. In summary, we firstly reported the epidemiological and etiological characteristics of HA in mainland China. Developing a multivalent vaccine will be helpful for the control of the HA/HFMD epidemic.


Assuntos
Enterovirus/classificação , Enterovirus/isolamento & purificação , Doença de Mão, Pé e Boca/epidemiologia , Doença de Mão, Pé e Boca/etiologia , Herpangina/epidemiologia , Herpangina/etiologia , Sorogrupo , Distribuição por Idade , Pré-Escolar , China/epidemiologia , Feminino , Humanos , Lactente , Masculino , Estações do Ano , Distribuição por Sexo
10.
Lancet ; 389(10069): 621-628, 2017 02 11.
Artigo em Inglês | MEDLINE | ID: mdl-28017399

RESUMO

BACKGROUND: A recombinant adenovirus type-5 vector-based vaccine expressing the glycoprotein of Ebola Zaire Makona variant showed good safety and immunogenicity in a phase 1 trial of healthy Chinese adults. We aimed to assess the safety and immunogenicity of this vaccine in healthy adults in Sierra Leone and to determine the optimal dose. METHODS: We did a single-centre, randomised, double-blind, placebo-controlled, phase 2 clinical trial at Sierra Leone-China Friendship Hospital, Freetown, Sierra Leone. We recruited healthy adults aged 18-50 years who were HIV negative, had no history of Ebola virus infection, and had no previous immunisation with other Ebola vaccine candidates. Participants were sequentially enrolled and randomly assigned (2:1:1), by computer-generated block randomisation (block size of eight), to receive the high-dose vaccine (1·6 × 1011 viral particles), low-dose vaccine (8·0 × 1010 viral particles), or placebo (containing only vaccine excipients, with no viral particles). Participants, investigators, and study staff (except two study pharmacists) were masked from treatment allocation. The primary safety outcome was occurrence of solicited adverse reactions within 7 days of vaccination, analysed by intention to treat. The primary immunogenicity outcome was glycoprotein-specific antibody responses at days 14, 28, and 168 after vaccination, analysed in all vaccinated participants who had blood samples drawn for antibody tests. The trial is registered with the Pan African Clinical Trials Registry, number PACTR201509001259869, and is completed. FINDINGS: During Oct 10-28, 2015, 500 participants were enrolled and randomly assigned to receive the high-dose vaccine (n=250), low-dose vaccine (n=125), or placebo (n=125). 132 (53%) participants in the high-dose group, 60 (48%) in the low-dose group, and 54 (43%) in the placebo group reported at least one solicited adverse reaction within 7 days of vaccination. Most adverse reactions were mild and self-limiting. Solicited injection-site adverse reactions were significantly more frequent in vaccine recipients (65 [26%] in high-dose group and 31 [25%] in low-dose group) than in those receiving placebo (17 [14%]; p=0·0169). Glycoprotein-specific antibody responses were detected from day 14 onwards (geometric mean titre 1251·0 [95% CI 976·6-1602·5] in low-dose group and 1728·4 [1459·4-2047·0] in high-dose group) and peaked at day 28 (1471·8 [1151·0-1881·8] and 2043·1 [1762·4-2368·4]), but declined quickly in the following months (223·3 [148·2-336·4] and 254·2 [185·0-349·5] at day 168). Geometric mean titres in the placebo group remained around 6·0-6·8 throughout the study period. Three serious adverse events (malaria, gastroenteritis, and one fatal asthma episode) were reported in the high-dose vaccine group, but none was deemed related to the vaccine. INTERPRETATION: The recombinant adenovirus type-5 vector-based Ebola vaccine was safe and highly immunogenic in healthy Sierra Leonean adults, and 8·0 × 1010 viral particles was the optimal dose. FUNDING: Chinese Ministry of Science and Technology and the National Health and Family Planning Commission, Beijing Institute of Biotechnology, and Tianjin CanSino Biotechnology.


Assuntos
Vacinas contra Ebola/efeitos adversos , Doença pelo Vírus Ebola/prevenção & controle , Imunogenicidade da Vacina/imunologia , Adenoviridae , Adulto , Método Duplo-Cego , Vacinas contra Ebola/administração & dosagem , Vacinas contra Ebola/imunologia , Ebolavirus/imunologia , Feminino , Vetores Genéticos , Glicoproteínas/imunologia , Voluntários Saudáveis , Humanos , Masculino , Serra Leoa , Vacinas Sintéticas/administração & dosagem , Vacinas Sintéticas/efeitos adversos , Vacinas Sintéticas/imunologia , Adulto Jovem
11.
Lancet Glob Health ; 5(3): e324-e334, 2017 03.
Artigo em Inglês | MEDLINE | ID: mdl-28017642

RESUMO

BACKGROUND: The 2013-15 Ebola virus disease epidemic in west Africa greatly accelerated the development of Ebola vaccine. We aimed to analyse the immune persistence induced by one shot of an adenovirus type-5 vector-based Ebola virus vaccine up to 6 months and the effect of boosting with a homologous vector in healthy adults in China. METHODS: In a randomised, double-blind, placebo-controlled, phase 1 clinical trial in one site in Jiangsu Province, China, 120 healthy adults aged 18-60 years received an initial dose of intramuscular adenovirus type-5 Ebola virus vaccine of 4·0 × 1010 viral particles, 1·6 × 1011 viral particles, or placebo, and were followed up to day 168. Participants were subsequently re-recruited to receive a booster dose of the same vaccine or placebo, in the same dose, at month 6. Women who were pregnant, breastfeeding, or planned to become pregnant during the next month were excluded. Randomisation was conducted by computer-generated block randomisation. Randomisation data were unmasked for interim analysis of the data obtained between days 0-28 but not disclosed to participants or site staff. Safety and immunogenicity analysis were done on the intention-to-treat population. We aimed to assess the safety profile of the experimental vaccine and the immunity responses to a single-dose immunisation or a homologous prime-boost regimen. Primary outcomes were Ebola glycoprotein-specific ELISA antibody responses 28 days post-boost and the occurrences of adverse reactions post-boost. The original trial and the extended booster study were registered with ClinicalTrials.gov, numbers NCT02326194 and NCT02533791, respectively. FINDINGS: Between Dec 28, 2014, and Jan 9, 2015, we enrolled 210 volunteers. 90 participants were not randomised due to not meeting inclusion criteria (61), meeting exclusion criteria (4), or withdrawal of consent (25). 120 people were randomly assigned to receive intramuscular Ebola vaccine at 4·0 × 1010 viral particles (low dose, n=40), Ebola vaccine at 1·6 × 1011 viral particles (high dose, n=40), or placebo (n=40, in two groups of 20). After prime vaccination, the geometric mean titer (GMT) of ELISA EC90 peaked at 682·7 (95% CI 424·3-1098·5) in the low-dose vaccine group and 1305·7 (970·1-1757·2) in the high-dose vaccine group at day 28, and then fell gradually through the next a few months to 575·5 (394·8-838·8) in the high-dose vaccine group and 197·9 (107·9-362·7) in the low-dose vaccine group at day 168. No specific response was recorded in the placebo group with a GMT of 5·0. Of the 120 participants involved in the initial trial, ten participants declined to participate, and 110 were included in the boost immunisation: 38 received the low dose, 35 received the high dose, and 37 received the placebo. At day 28 after boost vaccination, the ELISA EC90 titres rapidly rose to 6110 (95% CI 4705-7935) in the low-dose group and to 11825 (8904-15705) in the high dose group. 78 of 110 participants reported at least one solicited adverse reaction within the first 7 days after booster administration. Both of the groups who received vaccine showed significantly higher incidence of mild or moderate solicited adverse reactions than did the placebo group. INTERPRETATION: The adenovirus 5-vectored Ebola vaccine of 1·6 × 1011 viral particles was highly immunogenic and safe. The lower dose of 4·0 × 1010 viral particles was also safe, but immunogenicity seemed to be more vulnerable to the pre-existing immunity of adenovirus 5. A homologous priming-boosting regimen with adenovirus type-5 Ebola vaccine at 6 months interval was able to elicit greater antibody responses with longer duration. These results support an immunisation strategy to implement a booster injection for a more durable protection against Ebola virus disease. FUNDING: Chinese Ministry of Science and Technology and The National Health and Family Planning Commission, Beijing Institute of Biotechnology, and Tianjin CanSino Biotechnology.


Assuntos
Adenoviridae , Vacinas contra Ebola/imunologia , Ebolavirus/imunologia , Doença pelo Vírus Ebola/prevenção & controle , Imunização Secundária , Vacinação , Vacinas Sintéticas/imunologia , Adulto , China , Método Duplo-Cego , Feminino , Vetores Genéticos , Doença pelo Vírus Ebola/virologia , Humanos , Masculino , Pessoa de Meia-Idade
13.
Biomed Environ Sci ; 29(4): 286-9, 2016 04.
Artigo em Inglês | MEDLINE | ID: mdl-27241739

RESUMO

Norovirus (NoV) is a pathogen that commonly causes viral diarrhea in children. Studies indicate that NoV recognizes human histo-blood group antigens (HBGAs) as cell attachment factors. In order to explore the correlation between of NoV infection and HBGAs, a cross-sectional study was conducted in children less than five years old who were hospitalized with diarrhea in two areas of China between November 2014 and February 2015. Of the paired stool and saliva samples taken from 424 children, NoV was detected in 24 (6%) children, with viral genotypes GII.3 (n=5), GII.4 (n=14), GII.12 (n=1), and GII.17 (n=4). All of the individuals having NoV infection were either secretors (Lea-b+/Lex-y+) or partial secretors (Lea+b+/Lex+y+) except one GII.3 infection of a non-secretor (Lea+b-/Lex+y-). These results suggest that secretor positive is associated with NoV infection, although non-secretors are not absolutely protected from NoV infection.


Assuntos
Antígenos de Grupos Sanguíneos/genética , Infecções por Caliciviridae/sangue , Infecções por Caliciviridae/complicações , Diarreia/sangue , Diarreia/etiologia , Gastroenterite/sangue , Norovirus/fisiologia , Infecções por Caliciviridae/virologia , Pré-Escolar , China , Estudos Transversais , Diarreia/virologia , Fezes/virologia , Gastroenterite/virologia , Genótipo , Humanos , Lactente
14.
Expert Rev Vaccines ; 15(7): 803-13, 2016 07.
Artigo em Inglês | MEDLINE | ID: mdl-27206811

RESUMO

INTRODUCTION: Enterovirus A71 (EV71) is the predominant causative agent of hand, foot, and mouth disease (HFMD), which is often associated with severe cases and even deaths. EV71-associated epidemics have emerged as a serious threat to public health, particularly in the Asia-Pacific region. AREAS COVERED: We searched PubMed using the terms 'enterovirus 71', 'hand, foot, and mouth disease', and 'vaccine', with no date or language restrictions for all publications before April 27, 2016. Among various vaccine candidates, the alum-adjuvant inactivated EV71 vaccines are most promising. Three alum-adjuvant inactivated EV71 vaccines developed by mainland China showed high efficacy, good immunogenicity persistence and acceptable safety profiles in clinical trials. Recently, two of these EV71 vaccines have been approved for marketing in China and the other one is undergoing the review process of licensure. In this manuscript, we summarized previous study results as well as discussed the regulatory affairs and post-market surveillances issues. Expert commentary: The marketing of EV71 vaccines is a milestone in the controlling of HFMD. International clinical trials are needed to further assess the efficacy and cross-immunogenicity. Establishing a sensitive pathogen monitoring system would be essential to monitor the variation of genotypes and control HFMD epidemics.


Assuntos
Enterovirus Humano A/imunologia , Doença de Mão, Pé e Boca/prevenção & controle , Vacinas Virais/imunologia , Adjuvantes Imunológicos/administração & dosagem , Compostos de Alúmen/administração & dosagem , Ásia , China , Ensaios Clínicos como Assunto , Aprovação de Drogas , Doença de Mão, Pé e Boca/epidemiologia , Humanos , Vacinas de Produtos Inativados/administração & dosagem , Vacinas de Produtos Inativados/efeitos adversos , Vacinas de Produtos Inativados/imunologia , Vacinas Virais/administração & dosagem , Vacinas Virais/efeitos adversos
15.
Arch Virol ; 161(7): 1945-7, 2016 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-27020571

RESUMO

To investigate the epidemiological data on coxsackievirus B3 (CVB3) infection and its incidence in infants and children, a prospective cohort study was carried out from 2012 to 2014 in Jiangsu Province, China. According to the results of seropositive rates and NTAb titers of CVB3, an epidemic of CVB3 infection was found, and a dynamic change in CVB3 neutralizing antibody was also observed. One case was recorded with CVB3-associated hand, foot and mouth disease (HFMD), and the isolates belonged to the CVB3 D2 subtype. Our data help us to better understand the epidemic characteristics of CVB3 infection in infants and children.


Assuntos
Infecções por Coxsackievirus/virologia , Enterovirus Humano B/isolamento & purificação , Anticorpos Neutralizantes/sangue , Anticorpos Antivirais/sangue , Pré-Escolar , China/epidemiologia , Infecções por Coxsackievirus/sangue , Infecções por Coxsackievirus/epidemiologia , Enterovirus Humano B/classificação , Enterovirus Humano B/genética , Feminino , Humanos , Lactente , Masculino , Estudos Prospectivos
17.
Expert Rev Vaccines ; 15(1): 129-37, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-26460695

RESUMO

OBJECTIVES: To evaluate the efficacy and immunogenicity of the Sinovac Enterovirus 71 (EV71) vaccine for up to two years. METHODS: We did a follow-up study of our initial randomized trial in 10,077 participants, who were randomized to receive EV71 vaccine or placebo in a 1:1 ratio and followed for 14 months. The extended follow-up study lasted for another 12 months and EV71-associated hand, foot, and mouth disease (HFMD) was the primary endpoint. RESULTS: The EV71 vaccine showed an efficacy of 95.1% (95%CI 63.6, 99.3) against EV71-associated HFMD during the extended follow-up and an overall efficacy of 94.7% (95%CI 87.8, 97.6) for two years. The EV71 vaccine elicited a sustained high level of neutralizing antibodies in participants, and no serious adverse event was judged to be related to the vaccination. CONCLUSION: The Sinovac EV71 vaccine could provide a sustained high protection against EV71-associated HFMDs for up to 2 years.


Assuntos
Transmissão de Doença Infecciosa/prevenção & controle , Enterovirus Humano A/imunologia , Doença de Mão, Pé e Boca/epidemiologia , Doença de Mão, Pé e Boca/prevenção & controle , Vacinas Virais/administração & dosagem , Vacinas Virais/imunologia , Anticorpos Neutralizantes/sangue , Anticorpos Antivirais/sangue , Pré-Escolar , Método Duplo-Cego , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/patologia , Feminino , Seguimentos , Humanos , Lactente , Masculino , Placebos/administração & dosagem , Resultado do Tratamento , Vacinas Virais/efeitos adversos
18.
Lancet ; 386(10002): 1457-64, 2015 Oct 10.
Artigo em Inglês | MEDLINE | ID: mdl-26142048

RESUMO

BACKGROUND: Helicobacter pylori is one of the most common gastric pathogens, affecting at least half the world's population, and is strongly associated with gastritis, peptic ulcer, gastric adenocarcinoma, and lymphoma. We aimed to assess the efficacy, safety, and immunogenicity of a three-dose oral recombinant H pylori vaccine in children in China. METHODS: We did this randomised, double-blind, placebo-controlled, phase 3 trial at one centre in Ganyu County, Jiangsu Province, China. Healthy children aged 6-15 years without past or present H pylori infection were randomly assigned (1:1), via computer-generated randomisation codes in blocks of ten, to receive the H pylori vaccine or placebo. Participants, their guardians, and study investigators were masked to treatment allocation. The primary efficacy endpoint was the occurrence of H pylori infection within 1 year after vaccination. We did analysis in the per-protocol population. This trial is registered with ClinicalTrials.gov, number NCT02302170. FINDINGS: Between Dec 2, 2004, and March 19, 2005, we randomly assigned 4464 participants to either the vaccine group (n=2232) or the placebo group (n=2232), of whom 4403 (99%) participants completed the three-dose vaccination schedule and were included in the per-protocol efficacy analysis. We extended follow-up to 3 years. We recorded 64 events of H pylori infection within the first year (14 events in 2074·3 person-years at risk in the vaccine group vs 50 events in 2089·6 person-years at risk in the placebo group), resulting in a vaccine efficacy of 71·8% (95% CI 48·2-85·6). 157 (7%) participants in the vaccine group and 161 (7%) participants in the placebo group reported at least one adverse reaction. Serious adverse events were reported in five (<1%) participants in the vaccine group and seven (<1%) participants in the placebo group, but none was considered to be vaccination related. INTERPRETATION: The oral recombinant H pylori vaccine was effective, safe, and immunogenic in H pylori-naive children. This vaccine could substantially reduce the incidence of H pylori infection; however, follow up over a longer period is needed to confirm the protection of the vaccine against H pylori-associated diseases. FUNDING: Chongqing Kangwei Biological Technology.


Assuntos
Vacinas Bacterianas/administração & dosagem , Infecções por Helicobacter/prevenção & controle , Helicobacter pylori/imunologia , Administração Oral , Adolescente , Fatores Etários , Vacinas Bacterianas/efeitos adversos , Vacinas Bacterianas/imunologia , Criança , Método Duplo-Cego , Feminino , Infecções por Helicobacter/imunologia , Humanos , Imunidade Ativa/imunologia , Masculino , Proteínas Recombinantes , Fatores Sexuais , Resultado do Tratamento
19.
Hum Vaccin Immunother ; 11(10): 2400-5, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26158689

RESUMO

In recent years, the epidemics of hand, foot, and mouth disease (HFMD) centered in the Asian-Pacific region have been characterized by high morbidity and mortality. Enterovirus 71 (EV71) infections were responsible for the majority of the infections leading to severe cases of HFMD and death. This is a community-based survey aimed to estimate the disease burden of EV71 in rural central China, especially for HFMD. From 2011 to 2013, demographic and socio-economic data were gathered from 343 ill children and their parents using a structured questionnaire. We quantified the health burden of disease resulting from EV71 infection in disability-adjusted life years (DALYs). Among 343 cases, 303 had confirmed HFMD, 6 presented with herpangina, 25 presented with respiratory symptoms, and 9 presented with non-specific symptoms. The number of severe cases was 47 (including 1 death) and all of these presented with HFMD. The total cost per patient for severe HFMD, mild HFMD, herpangina, respiratory disease, and non-specific disease was $2149.47, $513.22, $53.28, $31.95, and $39.25, respectively. The overall cost of EV71-related diseases as a proportion of local farmers' per capita net income ranged from 0.18% for those with non-specific disease to 187.12% for those with severe HFMD. The loss of DALYs for the 5 forms of disease were 3.47, 1.76, 1.07, 1.44, 1.22 person-years per 1000 persons, respectively. This study provides data on cost of treatment and health burden for diseases caused by EV71, which can be used in the evaluation of EV71 vaccine cost-effectiveness.


Assuntos
Enterovirus Humano A/isolamento & purificação , Doença de Mão, Pé e Boca/epidemiologia , Doença de Mão, Pé e Boca/virologia , Criança , Pré-Escolar , China/epidemiologia , Efeitos Psicossociais da Doença , Feminino , Doença de Mão, Pé e Boca/patologia , Humanos , Lactente , Masculino , Prevalência , População Rural , Inquéritos e Questionários
20.
J Med Virol ; 87(12): 2009-17, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26010334

RESUMO

Epidemiological data from active surveillance on human enterovirus, which could cause hand, foot, and mouth disease, were limited. An active surveillance system was used to investigate the enterovirus spectrum and the incidence of different enteroviruses in infants aged 6-35 months in Jiangsu Province from 2012 to 2013. Fifty-nine infants were randomly selected from 522 non-EV-A71/CV-A16 HFMD patients. We collected 173 throat swabs and 174 rectal swabs from these infants. RT-PCR was used to amplify 5'-UTR and VP1 regions of enteroviruses and the serotypes were determined by the sequence comparison using BLAST. Twenty-one non-EV-A71/CA16 enterovirus serotypes were detected in those infants. E16, E18 were firstly reported in HFMD patients. The four top common non-EV-A71/CV-A enteroviruses among infants were CV-B3, CV-A10, CV-A6, and E9 with the HFMD incidence rates at 1.4%, 0.84%, 0.56%, and 0.47%, respectively. Over 20.8% patients were co-infected with multiple enteroviruses. Neither the course of sickness nor clinical symptoms of the co-infected patients was more severe than those infected with single enterovirus. Two patients were infected different enterovirus successively within 2 months. Several new enterovirus serotypes and multiple models of infection associated with HFMD were discovered through the active surveillance system. These data provide a better understanding of the viral etiology of HFMD.


Assuntos
Enterovirus/classificação , Enterovirus/isolamento & purificação , Monitoramento Epidemiológico , Doença de Mão, Pé e Boca/epidemiologia , Doença de Mão, Pé e Boca/virologia , Pré-Escolar , China/epidemiologia , Coinfecção/epidemiologia , Coinfecção/virologia , Enterovirus/genética , Fezes/virologia , Feminino , Genótipo , Doença de Mão, Pé e Boca/prevenção & controle , Humanos , Incidência , Lactente , Epidemiologia Molecular , Faringe/virologia , RNA Viral/genética , Análise de Sequência de DNA , Sorogrupo , Vacinas de Produtos Inativados/administração & dosagem , Vacinas de Produtos Inativados/imunologia , Vacinas Virais/administração & dosagem , Vacinas Virais/imunologia
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