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Pesquisa : D12.776.828.868.940 [Categoria DeCS]
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[PMID]:27093164
[Au] Autor:Dagan R; Ashkenazi S; Livni G; Go O; Bagchi P; Sarnecki M
[Ad] Endereço:From the *Soroka University Medical Center, Beer-Sheva, Israel; †Schneider Children's Medical Center, Petach Tikva and Sackler Faculty of Medicine, Tel Aviv, Israel; ‡Janssen Research & Development, LLC, Raritan, New Jersey; and §Janssen Vaccines AG, Berne, Switzerland.
[Ti] Título:Long-term Serologic Follow-up of Children Vaccinated with a Pediatric Formulation of Virosomal Hepatitis A Vaccine Administered With Routine Childhood Vaccines at 12-15 Months of Age.
[So] Source:Pediatr Infect Dis J;35(7):e220-8, 2016 07.
[Is] ISSN:1532-0987
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: The aim of this open-label, active-controlled, parallel group, phase 2 follow-up study was to assess the long-term immunogenicity of Epaxal Junior, the pediatric dose of an aluminum-free virosomal inactivated hepatitis A virus (HAV) vaccine, in children receiving routine childhood vaccines (RCV). METHODS: Healthy children (12-15 months old, ≥8 kg weight) were randomized (1:1:1) to group A: Epaxal Junior + RCV (day 1); group B: Epaxal Junior (day 1) + RCV (day 29) and group C: Havrix 720 + RCV (day 1). All 3 groups received 2 doses of HAV vaccines 6 months apart. Children who completed the primary study were followed up from 18 months to 7.5 years post booster. RESULTS: Of 291/327 randomized children who had completed the primary study, 157 were followed for the 7.5-year analysis (group A: 50; group B: 54; and group C: 53). Of these, 152 children had protective levels of anti-HAV antibodies [≥10 mIU/mL; 98% (group A); 96.3% (group B); 96.2% (group C)]. Anti-HAV geometric mean concentrations were similar in groups A and B at all the time points (1.5-, 2.5-, 3.5-, 5.25- and 7.5-year time point) but slightly lower in group C. Predictions of the median duration of persistence of seroprotective antibody levels, using the linear mixed model were similar in all groups: (group A: 19.1 years, group B: 18.7 years, group C: 17.3 years). CONCLUSIONS: Immunization with Epaxal Junior administered with RCVs at 12 months elicited protective response beyond 7.5 years in almost all children. Assessing the kinetic of anti-HAV antibody titers decline over time, the moment to reach antibody concentrations below the accepted protective level may occur earlier than previously estimated.
[Mh] Termos MeSH primário: Vacinas contra Hepatite A/administração & dosagem
Vacinas contra Hepatite A/sangue
[Mh] Termos MeSH secundário: Feminino
Seguimentos
Hepatite A/imunologia
Hepatite A/prevenção & controle
Anticorpos Anti-Hepatite A/sangue
Vacinas contra Hepatite A/efeitos adversos
Vacinas contra Hepatite A/imunologia
Vírus da Hepatite A Humana/imunologia
Seres Humanos
Esquemas de Imunização
Imunização Secundária
Lactente
Masculino
Vacinas de Produtos Inativados/administração & dosagem
Vacinas de Produtos Inativados/efeitos adversos
Vacinas de Produtos Inativados/sangue
Vacinas de Produtos Inativados/imunologia
Vacinas Virossomais/administração & dosagem
Vacinas Virossomais/efeitos adversos
Vacinas Virossomais/sangue
Vacinas Virossomais/imunologia
[Pt] Tipo de publicação:JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Hepatitis A Antibodies); 0 (Hepatitis A Vaccines); 0 (Vaccines, Inactivated); 0 (Vaccines, Virosome); 0 (epaxal berna)
[Em] Mês de entrada:1705
[Cu] Atualização por classe:170531
[Lr] Data última revisão:
170531
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160420
[St] Status:MEDLINE
[do] DOI:10.1097/INF.0000000000001176


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[PMID]:26666439
[Au] Autor:Jin H; Xia X; Liu B; Fu Y; Chen X; Wang H; Xia Z
[Ad] Endereço:Changchun SR Biological Technology Co., LTD, Changchun, 130012, China. jin8616771@163.com.
[Ti] Título:High-yield production of canine parvovirus virus-like particles in a baculovirus expression system.
[So] Source:Arch Virol;161(3):705-10, 2016 Mar.
[Is] ISSN:1432-8798
[Cp] País de publicação:Austria
[La] Idioma:eng
[Ab] Resumo:An optimized VP2 gene from the current prevalent CPV strain (new CPV-2a) in China was expressed in a baculovirus expression system. It was found that the VP2 proteins assembled into virus-like particles (VLPs) with antigenic properties similar to those of natural CPV and with an especially high hemagglutination (HA) titer (1:2(20)). Dogs intramuscularly or orally immunized with VLPs produced antibodies against CPV with >1:80 hemagglutination inhibition (HI) units for at least 3 months. The CPV VLPs could be considered for use as a vaccine against CPV or as a platform for research on chimeric VLP vaccines against other diseases.
[Mh] Termos MeSH primário: Baculoviridae
Vetores Genéticos
Parvovirus Canino/genética
Proteínas Estruturais Virais/metabolismo
Virossomos/metabolismo
[Mh] Termos MeSH secundário: Administração Oral
Animais
Anticorpos Antivirais/sangue
China
Cães
Injeções Intramusculares
Multimerização Proteica
Vacinas Virossomais/administração & dosagem
Vacinas Virossomais/genética
Vacinas Virossomais/imunologia
Proteínas Estruturais Virais/genética
Vacinas Virais/administração & dosagem
Vacinas Virais/genética
Vacinas Virais/imunologia
Virossomos/genética
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Antibodies, Viral); 0 (Vaccines, Virosome); 0 (Viral Structural Proteins); 0 (Viral Vaccines); 0 (Virosomes)
[Em] Mês de entrada:1606
[Cu] Atualização por classe:160224
[Lr] Data última revisão:
160224
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:151216
[St] Status:MEDLINE
[do] DOI:10.1007/s00705-015-2719-1


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[PMID]:26402787
[Au] Autor:Cox F; Roos A; Hafkemeijer N; Baart M; Tolboom J; Dekking L; Stittelaar K; Goudsmit J; Radosevic K; Saeland E
[Ad] Endereço:Janssen Prevention Center, Center of Excellence of Janssen Research & Development, Pharmaceutical companies of Johnson and Johnson, Leiden, The Netherlands.
[Ti] Título:Matrix-M Adjuvated Seasonal Virosomal Influenza Vaccine Induces Partial Protection in Mice and Ferrets against Avian H5 and H7 Challenge.
[So] Source:PLoS One;10(9):e0135723, 2015.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:There is a constant threat of zoonotic influenza viruses causing a pandemic outbreak in humans. It is virtually impossible to predict which virus strain will cause the next pandemic and it takes a considerable amount of time before a safe and effective vaccine will be available once a pandemic occurs. In addition, development of pandemic vaccines is hampered by the generally poor immunogenicity of avian influenza viruses in humans. An effective pre-pandemic vaccine is therefore required as a first line of defense. Broadening of the protective efficacy of current seasonal vaccines by adding an adjuvant may be a way to provide such first line of defense. Here we evaluate whether a seasonal trivalent virosomal vaccine (TVV) adjuvated with the saponin-based adjuvant Matrix-M (MM) can confer protection against avian influenza H5 and H7 virus strains in mice and ferrets. We demonstrate that mice were protected from death against challenges with H5N1 and H7N7, but that the protection was not complete as evidenced by severe clinical signs. In ferrets, protection against H7N9 was not observed. In contrast, reduced upper and lower respiratory tract viral loads and reduced lung pathology, was achieved in H5N1 challenged ferrets. Together these results suggest that, at least to some extent, Matrix-M adjuvated seasonal virosomal influenza vaccine can serve as an interim measure to decrease morbidity and mortality associated with a pandemic outbreak.
[Mh] Termos MeSH primário: Adjuvantes Imunológicos
Vírus da Influenza A/imunologia
Vacinas contra Influenza/imunologia
Infecções por Orthomyxoviridae/prevenção & controle
Proteínas da Matriz Viral/imunologia
[Mh] Termos MeSH secundário: Animais
Anticorpos Antivirais/sangue
Anticorpos Antivirais/imunologia
Reações Cruzadas/imunologia
Modelos Animais de Doenças
Feminino
Furões
Imunização
Vírus da Influenza A/classificação
Vacinas contra Influenza/administração & dosagem
Camundongos
Infecções por Orthomyxoviridae/imunologia
Infecções por Orthomyxoviridae/virologia
Vacinas Virossomais
Replicação Viral
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Adjuvants, Immunologic); 0 (Antibodies, Viral); 0 (Influenza Vaccines); 0 (Vaccines, Virosome); 0 (Viral Matrix Proteins)
[Em] Mês de entrada:1606
[Cu] Atualização por classe:151002
[Lr] Data última revisão:
151002
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:150925
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0135723


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[PMID]:26232121
[Au] Autor:Ortiz de Lejarazu R; Tamames S
[Ad] Endereço:Servicio de Microbiología e Inmunología, Hospital Clínico Universitario de Valladolid y Centro Nacional de Gripe, Valladolid, España. Electronic address: rortizdelejarazu@saludcastillayleon.es.
[Ti] Título:[Influenza vaccination. Effectiveness of current vaccines and future challenges].
[Ti] Título:Vacunación antigripal. Efectividad de las vacunas actuales y retos de futuro..
[So] Source:Enferm Infecc Microbiol Clin;33(7):480-90, 2015 Aug-Sep.
[Is] ISSN:1578-1852
[Cp] País de publicação:Spain
[La] Idioma:spa
[Ab] Resumo:Seasonal influenza is an annual challenge for health-care systems, due to factors such as co-circulation of 2 influenza A subtypes jointly with 2 influenza B lineages; the antigenic drift of these virus, which eludes natural immunity, as well as immunity conferred by vaccination; together with influenza impact in terms of morbidity and mortality. Influenza vaccines have been available for more than 70 years and they have progressed in formulation, production and delivery route. Recommendations on vaccination are focused on those with a higher probability of severe disease, and have a progressively wider coverage, and classically based on inactivated vaccines, but with an increasing importance of attenuated live vaccines. More inactivated vaccines are becoming available, from adyuvanted and virosomal vaccines to intradermal delivery, cell-culture or quadrivalent. Overall vaccine effectiveness is about 65%, but varies depending on characteristics of vaccines, virus, population and the outcomes to be prevented, and ranges from less than 10% to almost 90%. Future challenges are formulations that confer more extensive and lasting protection, as well as increased vaccination coverage, especially in groups such as pregnant women and health-care professionals, as well as being extended to paediatrics.
[Mh] Termos MeSH primário: Vacinas contra Influenza/imunologia
Influenza Humana/prevenção & controle
Potência de Vacina
[Mh] Termos MeSH secundário: Adolescente
Adulto
Idoso
Idoso de 80 Anos ou mais
Animais
Variação Antigênica
Criança
Pré-Escolar
Surtos de Doenças/prevenção & controle
Feminino
Previsões
Seres Humanos
Esquemas de Imunização
Lactente
Vírus da Influenza A/imunologia
Vírus da Influenza B/imunologia
Vacinas contra Influenza/classificação
Influenza Humana/epidemiologia
Masculino
Meia-Idade
Guias de Prática Clínica como Assunto
Gravidez
Vacinas Atenuadas
Vacinas de Produtos Inativados
Vacinas Virossomais
Adulto Jovem
Zoonoses
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Influenza Vaccines); 0 (Vaccines, Attenuated); 0 (Vaccines, Inactivated); 0 (Vaccines, Virosome)
[Em] Mês de entrada:1703
[Cu] Atualização por classe:170330
[Lr] Data última revisão:
170330
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:150802
[St] Status:MEDLINE


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[PMID]:25909814
[Au] Autor:Momose H; Mizukami T; Kuramitsu M; Takizawa K; Masumi A; Araki K; Furuhata K; Yamaguchi K; Hamaguchi I
[Ad] Endereço:Department of Safety Research on Blood and Biological Products, National Institute of Infectious Diseases, Musashimurayama, Tokyo, Japan.
[Ti] Título:Establishment of a new quality control and vaccine safety test for influenza vaccines and adjuvants using gene expression profiling.
[So] Source:PLoS One;10(4):e0124392, 2015.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:We have previously identified 17 biomarker genes which were upregulated by whole virion influenza vaccines, and reported that gene expression profiles of these biomarker genes had a good correlation with conventional animal safety tests checking body weight and leukocyte counts. In this study, we have shown that conventional animal tests showed varied and no dose-dependent results in serially diluted bulk materials of influenza HA vaccines. In contrast, dose dependency was clearly shown in the expression profiles of biomarker genes, demonstrating higher sensitivity of gene expression analysis than the current animal safety tests of influenza vaccines. The introduction of branched DNA based-concurrent expression analysis could simplify the complexity of multiple gene expression approach, and could shorten the test period from 7 days to 3 days. Furthermore, upregulation of 10 genes, Zbp1, Mx2, Irf7, Lgals9, Ifi47, Tapbp, Timp1, Trafd1, Psmb9, and Tap2, was seen upon virosomal-adjuvanted vaccine treatment, indicating that these biomarkers could be useful for the safety control of virosomal-adjuvanted vaccines. In summary, profiling biomarker gene expression could be a useful, rapid, and highly sensitive method of animal safety testing compared with conventional methods, and could be used to evaluate the safety of various types of influenza vaccines, including adjuvanted vaccine.
[Mh] Termos MeSH primário: Adjuvantes Imunológicos/farmacologia
Vacinas contra Influenza/farmacologia
[Mh] Termos MeSH secundário: Adjuvantes Imunológicos/administração & dosagem
Adjuvantes Imunológicos/efeitos adversos
Animais
Ensaio de Amplificação de Sinal de DNA Ramificado/métodos
Perfilação da Expressão Gênica/métodos
Marcadores Genéticos
Seres Humanos
Vacinas contra Influenza/administração & dosagem
Vacinas contra Influenza/efeitos adversos
Masculino
Controle de Qualidade
Ratos
Ratos Wistar
Segurança
Regulação para Cima
Vacinas Virossomais/administração & dosagem
Vacinas Virossomais/efeitos adversos
Vacinas Virossomais/farmacologia
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Adjuvants, Immunologic); 0 (Genetic Markers); 0 (Influenza Vaccines); 0 (Vaccines, Virosome)
[Em] Mês de entrada:1604
[Cu] Atualização por classe:170220
[Lr] Data última revisão:
170220
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:150425
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0124392


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[PMID]:25389920
[Au] Autor:Van Herck K; Hens A; De Coster I; Vertruyen A; Tolboom J; Sarnecki M; Van Damme P
[Ad] Endereço:From the *Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Belgium; †Department of Public Health, Ghent University, Ghent, Belgium; ‡GZA Campus Sint-Vincentius, Antwerp, Belgium; §Crucell Holland BV, Leiden, The Netherlands; and ¶Crucell Switzerland AG, Bern, Switzerland.
[Ti] Título:Long-term antibody persistence in children after vaccination with the pediatric formulation of an aluminum-free virosomal hepatitis A vaccine.
[So] Source:Pediatr Infect Dis J;34(4):e85-91, 2015 Apr.
[Is] ISSN:1532-0987
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: The pediatric dose of the virosomal hepatitis A vaccine Epaxal, Epaxal Junior, is safe and immunogenic in children from 1 to 17 years of age. The present study investigated the long-term immunogenicity of Epaxal Junior. The standard doses of Epaxal and aluminum-adsorbed hepatitis A vaccine (Havrix Junior) were used as comparators. METHODS: A total of 271 children who had completed a 0/6-month immunization schedule (priming and booster dose) participated in this follow-up study. Anti-hepatitis A virus (HAV) antibody levels were measured using a microparticle enzyme immunoassay (HAVAB 2.0 Quantitative; Abbott Diagnostics, Wiesbaden, Germany) starting at 18 months following the second dose, and then yearly until 66 months (ie, 5.5 years) after the second dose. RESULTS: All subjects tested at Month 66 still had protective anti-HAV antibodies (≥10 mIU/mL). Antibody titers were generally lower in subjects 1-7 years old than in subjects 8-17 years old and higher in females 11-17 years old than in males 11-17 years old. In addition, an age-dependent decay was observed, that is, antibody decreased more rapidly in younger than in older children. CONCLUSIONS: Vaccination of children with two doses of Epaxal Junior confers a real-time protection of at least 5.5 years. This protection is estimated to last approximately 25 years. Younger children showed lower antibody titers and a faster antibody decline than older children. Additional follow-up studies are needed beyond 5.5 years to further assess the long-term immunogenicity of Epaxal Junior.
[Mh] Termos MeSH primário: Anticorpos Anti-Hepatite A/sangue
Vacinas contra Hepatite A/administração & dosagem
Vacinas contra Hepatite A/imunologia
Vacinação/métodos
Vacinas Virossomais/administração & dosagem
Vacinas Virossomais/imunologia
[Mh] Termos MeSH secundário: Adolescente
Criança
Pré-Escolar
Feminino
Seres Humanos
Imunoensaio
Lactente
Estudos Longitudinais
Fatores de Tempo
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE II; JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Hepatitis A Antibodies); 0 (Hepatitis A Vaccines); 0 (Vaccines, Virosome); 0 (epaxal berna)
[Em] Mês de entrada:1511
[Cu] Atualização por classe:150312
[Lr] Data última revisão:
150312
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:141113
[St] Status:MEDLINE
[do] DOI:10.1097/INF.0000000000000616


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[PMID]:25344321
[Au] Autor:Soema PC; Rosendahl Huber SK; Willems GJ; Jiskoot W; Kersten GF; Amorij JP
[Ad] Endereço:Intravacc (Institute for Translational Vaccinology), Antonie van Leeuwenhoeklaan 9, 3721 MA, Bilthoven, The Netherlands, peter.soema@intravacc.nl.
[Ti] Título:Influenza T-cell epitope-loaded virosomes adjuvanted with CpG as a potential influenza vaccine.
[So] Source:Pharm Res;32(4):1505-15, 2015 Apr.
[Is] ISSN:1573-904X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:PURPOSE: Influenza CD8(+) T-cell epitopes are conserved amongst influenza strains and can be recognized by influenza-specific cytotoxic T-cells (CTLs), which can rapidly clear infected cells. An influenza peptide vaccine that elicits these CTLs would therefore be an alternative to current influenza vaccines, which are not cross-reactive. However, peptide antigens are poorly immunogenic due to lack of delivery to antigen presenting cells, and therefore need additional formulation with a suitable delivery system. In this study, the potential of virosomes as a delivery system for an influenza T-cell peptide was investigated. METHODS: The conserved human HLA-A2.1 influenza T-cell epitope M158-66 was formulated with virosomes. The immunogenicity and protective effect of the peptide-loaded virosomes was assessed in HLA-A2 transgenic mice. Delivery properties of the virosomes were studied in mice and in in vitro dendritic cell cultures. RESULTS: Immunization of HLA-A2.1 transgenic C57BL/6 mice with peptide-loaded virosomes in the presence of the adjuvant CpG-ODN 1826 increased the number of peptide-specific CTLs. Vaccination with adjuvanted peptide-loaded virosomes reduced weight loss in mice after heterologous influenza infection. Association with fusion-active virosomes was found to be crucial for antigen uptake by dendritic cells, and subsequent induction of CTLs in mice. CONCLUSIONS: These results show that influenza virosomes loaded with conserved influenza epitopes could be the basis of a novel cross-protective influenza vaccine.
[Mh] Termos MeSH primário: Adjuvantes Imunológicos/química
Epitopos de Linfócito T/imunologia
Antígeno HLA-A2/imunologia
Vacinas contra Influenza/administração & dosagem
Oligodesoxirribonucleotídeos/química
[Mh] Termos MeSH secundário: Animais
Antígeno HLA-A2/genética
Seres Humanos
Vacinas contra Influenza/química
Camundongos Endogâmicos C57BL
Camundongos Transgênicos
Fragmentos de Peptídeos/imunologia
Vacinas Virossomais/administração & dosagem
Vacinas Virossomais/química
Proteínas da Matriz Viral/imunologia
Virossomos
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Adjuvants, Immunologic); 0 (CpG ODN 1826); 0 (Epitopes, T-Lymphocyte); 0 (HLA-A*02:01 antigen); 0 (HLA-A2 Antigen); 0 (Influenza Vaccines); 0 (M1 protein, Influenza A virus); 0 (Oligodeoxyribonucleotides); 0 (Peptide Fragments); 0 (Vaccines, Virosome); 0 (Viral Matrix Proteins); 0 (Virosomes)
[Em] Mês de entrada:1512
[Cu] Atualização por classe:150319
[Lr] Data última revisão:
150319
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:141026
[St] Status:MEDLINE
[do] DOI:10.1007/s11095-014-1556-3


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[PMID]:25424948
[Au] Autor:Pedersen GK; Sjursen H; Nøstbakken JK; Jul-Larsen Å; Hoschler K; Cox RJ
[Ad] Endereço:a Department of Clinical Science; University of Bergen; Bergen, Norway.
[Ti] Título:Matrix M(TM) adjuvanted virosomal H5N1 vaccine induces balanced Th1/Th2 CD4(+) T cell responses in man.
[So] Source:Hum Vaccin Immunother;10(8):2408-16, 2014.
[Is] ISSN:2164-554X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:T cellular responses play a significant role in mediating protective immune responses against influenza in humans. In the current study, we evaluated the ability of a candidate virosomal H5N1 vaccine adjuvanted with Matrix M(TM) to induce CD4(+) and CD8(+) T cell responses in a phase 1 clinical trial. We vaccinated 60 healthy adult volunteers (at days 0 and 21) with 30 µg haemagglutinin (HA) alone or 1.5, 7.5, or 30 µg HA formulated with Matrix M(TM). To evaluate the T cellular responses, lymphocytes were stimulated in vitro with homologous (A/Vietnam/1194/2004 [H5N1]) and heterologous H5N1 (A/Anhui/1/05 or A/Bar-headed Goose/Qinghai/1A/05) antigens. The antigen-specific cytokine responses were measured by intracellular cytokine staining and by multiplex (Luminex) assays. An increase in CD4(+) Th1 and Th2 cytokines was detected 21 days after the first vaccine dose. No increase in Th cytokine responses was observed after the second dose, although it is possible that the cytokine levels peaked earlier than sampling point at day 42. Formulation with the Matrix M(TM) adjuvant augmented both the homologous and cross-reactive cytokine response. Antigen-specific CD8(+) T cell responses were detected only in a few vaccinated individuals. The concentrations of Th1 and to a lesser extent, Th2 cytokines at 21 days post-vaccination correlated moderately with subsequent days 35 and 180 serological responses as measured by the microneutralisation, haemagglutination inhibition, and single radial hemolysis assays. Results presented here show that the virosomal H5N1 vaccine induced balanced Th1/Th2 cytokine responses and that Matrix M(TM) is a promising adjuvant for future development of candidate pandemic influenza vaccines.
[Mh] Termos MeSH primário: Adjuvantes Imunológicos/administração & dosagem
Linfócitos T CD4-Positivos/imunologia
Vírus da Influenza A Subtipo H5N1/imunologia
Vacinas contra Influenza/imunologia
Células Th1/imunologia
Células Th2/imunologia
[Mh] Termos MeSH secundário: Adulto
Linfócitos T CD8-Positivos/imunologia
Citocinas/secreção
Feminino
Voluntários Saudáveis
Seres Humanos
Vacinas contra Influenza/administração & dosagem
Masculino
Vacinas Virossomais/administração & dosagem
Vacinas Virossomais/imunologia
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE I; JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Adjuvants, Immunologic); 0 (Cytokines); 0 (Influenza Vaccines); 0 (Vaccines, Virosome)
[Em] Mês de entrada:1507
[Cu] Atualização por classe:170220
[Lr] Data última revisão:
170220
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:141127
[St] Status:MEDLINE
[do] DOI:10.4161/hv.29583


  9 / 216 MEDLINE  
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[PMID]:25424821
[Au] Autor:Jain H; Kumavat V; Singh T; Versteilen A; Sarnecki M
[Ad] Endereço:a MGM Medical College & Chacha Nehru Bal Chikitsalay; Indore, India.
[Ti] Título:Immunogenicity and safety of a pediatric dose of a virosomal hepatitis A vaccine in healthy children in India.
[So] Source:Hum Vaccin Immunother;10(7):2089-97, 2014.
[Is] ISSN:2164-554X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:As India is transitioning from high to intermediate hepatitis A endemicity, the need for hepatitis A vaccination programs increases. This study investigated the immunogenicity and safety of a virosomal hepatitis A vaccine (HAVpur Junior) compared with an aluminum-adsorbed hepatitis A vaccine (Havrix 720 Junior) in Indian children. Healthy children aged 18-47 months, stratified by age, were randomized to either HAVpur Junior or Havrix 720 Junior. The first dose of vaccine was administered on Day 1 and the second (booster) dose 6 months later. Antibodies against hepatitis A virus (HAV) were measured using a microparticle enzyme immunoassay. The primary objective assessed non-inferiority of HAVpur Junior to Havrix 720 Junior in terms of seroprotection rates (≥ 10 mIU/mL anti-HAV antibodies) at 1 month after the first vaccination. Non-inferiority was demonstrated if the lower limit of the 90% confidence interval of the group difference was greater than -10%. Local and systemic adverse events were recorded. The seroprotection rate at 1 month was 95.9% in the HAVpur Junior group and 96.6% in the Havrix 720 Junior group. As the lower limit of the 90% confidence interval of the group difference was greater than -10% (-4.7), non-inferiority of HAVpur Junior to Havrix 720 Junior was established. The overall incidence of adverse events (solicited and unsolicited) after each vaccination was similar in both groups. In conclusion, the aluminum-free virosomal vaccine HAVpur Junior induced a similar immune response to Havrix 720 Junior in healthy Indian children aged 18 to 47 months. Both vaccines were well tolerated. The study shows that the low-dose virosomal HAV vaccine is consistently efficacious and well tolerated in children of all age groups and is suitable for inclusion into Indian childhood vaccination schedules.
[Mh] Termos MeSH primário: Anticorpos Anti-Hepatite A/sangue
Vacinas contra Hepatite A/efeitos adversos
Vacinas contra Hepatite A/imunologia
Hepatite A/prevenção & controle
[Mh] Termos MeSH secundário: Adjuvantes Imunológicos/administração & dosagem
Hidróxido de Alumínio/administração & dosagem
Pré-Escolar
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/patologia
Feminino
Voluntários Saudáveis
Vacinas contra Hepatite A/administração & dosagem
Seres Humanos
Técnicas Imunoenzimáticas
Índia
Lactente
Masculino
Vacinas Virossomais/administração & dosagem
Vacinas Virossomais/efeitos adversos
Vacinas Virossomais/imunologia
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE IV; COMPARATIVE STUDY; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Adjuvants, Immunologic); 0 (Hepatitis A Antibodies); 0 (Hepatitis A Vaccines); 0 (Vaccines, Virosome); 5QB0T2IUN0 (Aluminum Hydroxide)
[Em] Mês de entrada:1602
[Cu] Atualização por classe:170220
[Lr] Data última revisão:
170220
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:141127
[St] Status:MEDLINE
[do] DOI:10.4161/hv.28631


  10 / 216 MEDLINE  
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[PMID]:25424806
[Au] Autor:Alicino C; Infante MT; Gandoglia I; Miolo N; Mancardi GL; Zappettini S; Capello E; Orsi A; Tamburini T; Grandis M
[Ad] Endereço:a Department of Health Sciences; Vaccines and Clinical Trials Unit; University of Genoa; Genoa Italy.
[Ti] Título:Acute disseminated encephalomyelitis with severe neurological outcomes following virosomal seasonal influenza vaccine.
[So] Source:Hum Vaccin Immunother;10(7):1969-73, 2014.
[Is] ISSN:2164-554X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Acute disseminated encephalomyelitis (ADEM) is an inflammatory, usually monophasic, immune mediate, demyelinating disease of the central nervous system which involves the white matter. ADEM is more frequent in children and usually occurs after viral infections, but may follow vaccinations, bacterial infections, or may occur without previous events. Only 5% of cases of ADEM are preceded by vaccination within one month prior to symptoms onset. The diagnosis of ADEM requires both multifocal involvement and encephalopathy and specific demyelinating lesions of white matter. Overall prognosis of ADEM patients is often favorable, with full recovery reported in 23% to 100% of patients from pediatric cohorts, and more severe outcome in adult patients. We describe the first case of ADEM occurred few days after administration of virosomal seasonal influenza vaccine. The patient, a 59-year-old caucasic man with unremarkable past medical history presented at admission decreased alertness, 10 days after flu vaccination. During the 2 days following hospitalization, his clinical conditions deteriorated with drowsiness and fever until coma. The magnetic resonance imaging of the brain showed multiple and symmetrical white matter lesions in both cerebellar and cerebral hemispheres, suggesting demyelinating disease with inflammatory activity, compatible with ADEM. The patient was treated with high dose of steroids and intravenous immunoglobulin with relevant sequelae and severe neurological outcomes.
[Mh] Termos MeSH primário: Encefalomielite Aguda Disseminada/complicações
Encefalomielite Aguda Disseminada/diagnóstico
Vacinas contra Influenza/efeitos adversos
Doenças do Sistema Nervoso/diagnóstico
[Mh] Termos MeSH secundário: Anti-Inflamatórios/uso terapêutico
Encéfalo/diagnóstico por imagem
Encéfalo/patologia
Encefalomielite Aguda Disseminada/tratamento farmacológico
Seres Humanos
Imunoglobulinas Intravenosas/uso terapêutico
Fatores Imunológicos/uso terapêutico
Vacinas contra Influenza/administração & dosagem
Imagem por Ressonância Magnética
Masculino
Meia-Idade
Radiografia
Esteroides/uso terapêutico
Vacinas Virossomais/administração & dosagem
Vacinas Virossomais/efeitos adversos
[Pt] Tipo de publicação:CASE REPORTS; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Anti-Inflammatory Agents); 0 (Immunoglobulins, Intravenous); 0 (Immunologic Factors); 0 (Influenza Vaccines); 0 (Steroids); 0 (Vaccines, Virosome)
[Em] Mês de entrada:1602
[Cu] Atualização por classe:170220
[Lr] Data última revisão:
170220
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:141127
[St] Status:MEDLINE
[do] DOI:10.4161/hv.28961



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