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[PMID]:28543534
[Au] Autor:Zeinalzadeh N; Salmanian AH; Goujani G; Amani J; Ahangari G; Akhavian A; Jafari M
[Ad] Endereço:Department of Animal Science, Faculty of Natural Science, University of Tabriz, Tabriz.
[Ti] Título:A Chimeric protein of CFA/I, CS6 subunits and LTB/STa toxoid protects immunized mice against enterotoxigenic Escherichia coli.
[So] Source:Microbiol Immunol;61(7):272-279, 2017 Jul.
[Is] ISSN:1348-0421
[Cp] País de publicação:Australia
[La] Idioma:eng
[Ab] Resumo:Enterotoxigenic Escherichia Coli (ETEC) strains are the commonest bacteria causing diarrhea in children in developing countries and travelers to these areas. Colonization factors (CFs) and enterotoxins are the main virulence determinants in ETEC pathogenesis. Heterogeneity of CFs is commonly considered the bottleneck to developing an effective vaccine. It is believed that broad spectrum protection against ETEC would be achieved by induced anti-CF and anti-enterotoxin immunity simultaneously. Here, a fusion antigen strategy was used to construct a quadrivalent recombinant protein called 3CL and composed of CfaB, a structural subunit of CFA/I, and CS6 structural subunits, LTB and STa toxoid of ETEC. Its anti-CF and antitoxin immunogenicity was then assessed. To achieve high-level expression, the 3CL gene was synthesized using E. coli codon bias. Female BALB/C mice were immunized with purified recombinant 3CL. Immunized mice developed antibodies that were capable of detecting each recombinant subunit in addition to native CS6 protein and also protected the mice against ETEC challenge. Moreover, sera from immunized mice also neutralized STa toxin in a suckling mouse assay. These results indicate that 3CL can induce anti-CF and neutralizing antitoxin antibodies along with introducing CFA/I as a platform for epitope insertion.
[Mh] Termos MeSH primário: Antígenos de Bactérias/imunologia
Escherichia coli Enterotoxigênica/imunologia
Vacinas contra Escherichia coli/imunologia
Proteínas Recombinantes de Fusão/imunologia
Toxoides/imunologia
[Mh] Termos MeSH secundário: Animais
Anticorpos Antibacterianos/sangue
Anticorpos Neutralizantes/imunologia
Antígenos de Bactérias/genética
Antitoxinas/imunologia
Toxinas Bacterianas/genética
Toxinas Bacterianas/imunologia
Colicinas/genética
Colicinas/imunologia
Enterotoxinas/genética
Enterotoxinas/imunologia
Enterotoxinas/toxicidade
Infecções por Escherichia coli/imunologia
Infecções por Escherichia coli/prevenção & controle
Proteínas de Escherichia coli/genética
Proteínas de Escherichia coli/imunologia
Vacinas contra Escherichia coli/genética
Feminino
Camundongos
Camundongos Endogâmicos BALB C
Proteínas Recombinantes de Fusão/genética
Toxoides/genética
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antibodies, Bacterial); 0 (Antibodies, Neutralizing); 0 (Antigens, Bacterial); 0 (Antitoxins); 0 (Bacterial Toxins); 0 (CS6 antigen, E coli); 0 (Colicins); 0 (Enterotoxins); 0 (Escherichia coli Proteins); 0 (Escherichia coli Vaccines); 0 (Recombinant Fusion Proteins); 0 (Toxoids); 0 (colicin 5 protein, E coli); 0 (heat stable toxin (E coli))
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171025
[Lr] Data última revisão:
171025
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170526
[St] Status:MEDLINE
[do] DOI:10.1111/1348-0421.12491


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[PMID]:28122669
[Au] Autor:Herrera M; González K; Rodríguez C; Gómez A; Segura Á; Vargas M; Villalta M; Estrada R; León G
[Ad] Endereço:Instituto Clodomiro Picado, Facultad de Microbiología, Universidad de Costa Rica, San José, Costa Rica; Sección de Química Analítica, Escuela de Química, Universidad de Costa Rica, San José, Costa Rica.
[Ti] Título:Active immunization of cattle with a bothropic toxoid does not abrogate envenomation by Bothrops asper venom, but increases the likelihood of survival.
[So] Source:Biologicals;46:1-5, 2017 Mar.
[Is] ISSN:1095-8320
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:This study assessed the protective effect of active immunization of cattle to prevent the envenomation induced by B. asper venom. Two groups of oxen were immunized with a bothropic toxoid and challenged by an intramuscular injection of either 10 or 50 mg B. asper venom, to induce moderate or severe envenomations, respectively. Non-immunized oxen were used as controls. It was found that immunized oxen developed local edema similar to those observed in non-immunized animals. However, systemic effects were totally prevented in immunized oxen challenged with 10 mg venom, and therefore antivenom treatment was not required. When immunized oxen were challenged with 50 mg venom, coagulopathy was manifested 3-16 h later than in non-immunized oxen, demonstrating a delay in the onset of systemic envenomation. In these animals, active immunization did not eliminate the need for antivenom treatment, but increased the time lapse in which antivenom administration is still effective. All experimentally envenomed oxen completely recovered after a week following venom injection. Our results suggest that immunization of cattle with a bothropic toxoid prevents the development of systemic effects in moderate envenomations by B. asper, but does not abrogate these effects in severe envenomation.
[Mh] Termos MeSH primário: Doenças dos Bovinos/prevenção & controle
Venenos de Crotalídeos/toxicidade
Mordeduras de Serpentes/veterinária
Toxoides/administração & dosagem
Vacinação
[Mh] Termos MeSH secundário: Animais
Antivenenos/imunologia
Antivenenos/farmacologia
Coagulação Sanguínea/efeitos dos fármacos
Testes de Coagulação Sanguínea
Bothrops/imunologia
Bovinos
Doenças dos Bovinos/induzido quimicamente
Doenças dos Bovinos/imunologia
Venenos de Crotalídeos/administração & dosagem
Relação Dose-Resposta a Droga
Edema/induzido quimicamente
Edema/imunologia
Edema/prevenção & controle
Injeções Intramusculares
Masculino
Substâncias Protetoras/administração & dosagem
Mordeduras de Serpentes/imunologia
Mordeduras de Serpentes/prevenção & controle
Análise de Sobrevida
Fatores de Tempo
Toxoides/imunologia
Resultado do Tratamento
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antivenins); 0 (Crotalid Venoms); 0 (Protective Agents); 0 (Toxoids)
[Em] Mês de entrada:1704
[Cu] Atualização por classe:170418
[Lr] Data última revisão:
170418
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170127
[St] Status:MEDLINE


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[PMID]:28010246
[Au] Autor:Landrum ML; Lalani T; Niknian M; Maguire JD; Hospenthal DR; Fattom A; Taylor K; Fraser J; Wilkins K; Ellis MW; Kessler PD; Fahim RE; Tribble DR
[Ad] Endereço:a Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics , Uniformed Services University of the Health Sciences , Rockville , MD , USA.
[Ti] Título:Safety and immunogenicity of a recombinant Staphylococcus aureus α-toxoid and a recombinant Panton-Valentine leukocidin subunit, in healthy adults.
[So] Source:Hum Vaccin Immunother;13(4):791-801, 2017 Apr 03.
[Is] ISSN:2164-554X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:We conducted a randomized, double-blind, placebo-controlled dose-escalation study in healthy adults to evaluate the safety and immunogenicity of recombinant Staphylococcus aureus candidate vaccine antigens, recombinant α-toxoid (rAT) and a sub-unit of Panton-Valentine leukocidin (rLukS-PV). 176 subjects were enrolled and randomized within 1 of 11 treatment cohorts: monovalent rAT or rLukS-PV dosages of 10, 25, 50, and 100 µg; bivalent rAT:rLukS dosages of 10:10, 25:25, and 50:50 µg; and alum or saline placebo. All subjects were assessed at Days 0, 7, 14, 28, and 84. Subjects in the 50:50 µg bivalent cohort received a second injection on Day 84 and were assessed on Days 98 and 112. Incidence and severity of reactogenicity and adverse events (AEs) were compared. Geometric mean serum concentrations (GMC) and neutralizing activity of anti-rAT and anti-rLukS-PV IgG were assessed. Reactogenicity incidence was significantly higher in vaccine than placebo recipients (77% versus 55%, respectively; p = 0.006). However, 77% of reactogenicity events were mild and 19% were moderate in severity. The AE incidence and severity were similar between the cohorts. All monovalent and bivalent rAT dosages resulted in a significant increase in the anti-rAT IgG and anti- rLukS-PV GMCs between day 0 and 28 compared with placebo, and persisted through Day 84. Exploratory subgroup analyses suggested a higher GMC and neutralizing antibody titers for the 50 µg monovalent or bivalent rAT and rLukS-PV dose as compared to the other doses. No booster effect was observed after administration of the second dose. We conclude that the rAT and rLukS-PV vaccine formulations were well-tolerated and had a favorable immunogenicity profile, producing antibody with neutralizing activity through day 84. There was no benefit observed with a booster dose of the vaccine.
[Mh] Termos MeSH primário: Toxinas Bacterianas/imunologia
Exotoxinas/imunologia
Proteínas Hemolisinas/imunologia
Leucocidinas/imunologia
Infecções Estafilocócicas/prevenção & controle
Vacinas Antiestafilocócicas/efeitos adversos
Vacinas Antiestafilocócicas/imunologia
Toxoides/imunologia
[Mh] Termos MeSH secundário: Adjuvantes Imunológicos/administração & dosagem
Adolescente
Adulto
Compostos de Alúmen/administração & dosagem
Anticorpos Antibacterianos/sangue
Anticorpos Neutralizantes/sangue
Toxinas Bacterianas/genética
Método Duplo-Cego
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/patologia
Exotoxinas/genética
Feminino
Voluntários Saudáveis
Proteínas Hemolisinas/genética
Seres Humanos
Imunoglobulina G/sangue
Leucocidinas/genética
Masculino
Meia-Idade
Placebos/administração & dosagem
Vacinas Antiestafilocócicas/administração & dosagem
Vacinas Antiestafilocócicas/genética
Toxoides/genética
Vacinas Sintéticas/administração & dosagem
Vacinas Sintéticas/efeitos adversos
Vacinas Sintéticas/genética
Vacinas Sintéticas/imunologia
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Adjuvants, Immunologic); 0 (Alum Compounds); 0 (Antibodies, Bacterial); 0 (Antibodies, Neutralizing); 0 (Bacterial Toxins); 0 (Exotoxins); 0 (Hemolysin Proteins); 0 (Immunoglobulin G); 0 (Leukocidins); 0 (Panton-Valentine leukocidin); 0 (Placebos); 0 (Staphylococcal Vaccines); 0 (Toxoids); 0 (Vaccines, Synthetic); 0 (staphylococcal alpha-toxin); 34S289N54E (aluminum sulfate)
[Em] Mês de entrada:1704
[Cu] Atualização por classe:170504
[Lr] Data última revisão:
170504
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161225
[St] Status:MEDLINE
[do] DOI:10.1080/21645515.2016.1248326


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[PMID]:27768518
[Au] Autor:Hermand P; Vandercammen A; Mertens E; Di Paolo E; Verlant V; Denoël P; Godfroid F
[Ad] Endereço:a GSK Vaccines , Rixensart , Belgium.
[Ti] Título:Preclinical evaluation of a chemically detoxified pneumolysin as pneumococcal vaccine antigen.
[So] Source:Hum Vaccin Immunother;13(1):220-228, 2017 Jan 02.
[Is] ISSN:2164-554X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The use of protein antigens able to protect against the majority of Streptococcus pneumoniae serotypes is envisaged as stand-alone and/or complement to the current capsular polysaccharide-based pneumococcal vaccines. Pneumolysin (Ply) is a key virulence factor that is highly conserved in amino acid sequence across pneumococcal serotypes, and therefore may be considered as a vaccine target. However, native Ply cannot be used in vaccines due to its intrinsic cytolytic activity. In the present work a completely, irreversibly detoxified pneumolysin (dPly) has been generated using an optimized formaldehyde treatment. Detoxi-fication was confirmed by dPly challenge in mice and histological analysis of the injection site in rats. Immunization with dPly elicited Ply-specific functional antibodies that were able to inhibit Ply activity in a hemolysis assay. In addition, immunization with dPly protected mice against lethal intranasal challenge with Ply, and intranasal immunization inhibited nasopharyngeal colonization after intranasal challenge with homologous or heterologous pneumococcal strain. Our findings supported dPly as a valid candidate antigen for further pneumococcal vaccine development.
[Mh] Termos MeSH primário: Antígenos de Bactérias/imunologia
Infecções Pneumocócicas/prevenção & controle
Vacinas Pneumocócicas/imunologia
Estreptolisinas/imunologia
Toxoides/imunologia
[Mh] Termos MeSH secundário: Animais
Anticorpos Antibacterianos/sangue
Antígenos de Bactérias/administração & dosagem
Proteínas de Bactérias/administração & dosagem
Proteínas de Bactérias/efeitos adversos
Proteínas de Bactérias/imunologia
Modelos Animais de Doenças
Feminino
Formaldeído/metabolismo
Masculino
Camundongos Endogâmicos BALB C
Infecções Pneumocócicas/imunologia
Vacinas Pneumocócicas/administração & dosagem
Ratos
Estreptolisinas/administração & dosagem
Estreptolisinas/efeitos adversos
Análise de Sobrevida
Toxoides/administração & dosagem
Toxoides/efeitos adversos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antibodies, Bacterial); 0 (Antigens, Bacterial); 0 (Bacterial Proteins); 0 (Pneumococcal Vaccines); 0 (Streptolysins); 0 (Toxoids); 0 (plY protein, Streptococcus pneumoniae); 1HG84L3525 (Formaldehyde)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171023
[Lr] Data última revisão:
171023
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161022
[St] Status:MEDLINE
[do] DOI:10.1080/21645515.2016.1234553


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[PMID]:27586408
[Au] Autor:Li P; Asokanathan C; Liu F; Khaing KK; Kmiec D; Wei X; Song B; Xing D; Kong D
[Ad] Endereço:Institute of Biomedical Engineering, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin Key Laboratory of Biomaterial Research, Tianjin 300192, China.
[Ti] Título:PLGA nano/micro particles encapsulated with pertussis toxoid (PTd) enhances Th1/Th17 immune response in a murine model.
[So] Source:Int J Pharm;513(1-2):183-190, 2016 Nov 20.
[Is] ISSN:1873-3476
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:Poly(lactic-co-glycolic acid) (PLGA) based nano/micro particles were investigated as a potential vaccine platform for pertussis antigen. Presentation of pertussis toxoid as nano/micro particles (NP/MP) gave similar antigen-specific IgG responses in mice compared to soluble antigen. Notably, in cell line based assays, it was found that PLGA based nano/micro particles enhanced the phagocytosis of fluorescent antigen-nano/micro particles by J774.2 murine monocyte/macrophage cells compared to soluble antigen. More importantly, when mice were immunised with the antigen-nano/micro particles they significantly increased antigen-specific Th1 cytokines INF-γ and IL-17 secretion in splenocytes after in vitro re-stimulation with heat killed Bordetalla pertussis, indicating the induction of a Th1/Th17 response. Also, presentation of pertussis antigen in a NP/MP formulation is able to provide protection against respiratory infection in a murine model. Thus, the NP/MP formulation may provide an alternative to conventional acellular vaccines to achieve a more balanced Th1/Th2 immune response.
[Mh] Termos MeSH primário: Ácido Láctico/química
Ácido Poliglicólico/química
Células Th1/imunologia
Células Th17/imunologia
Toxoides/administração & dosagem
[Mh] Termos MeSH secundário: Animais
Antígenos de Bactérias/imunologia
Bordetella pertussis/imunologia
Linhagem Celular
Feminino
Imunoglobulina G/imunologia
Interferon gama/imunologia
Interleucina-17/imunologia
Macrófagos/imunologia
Camundongos
Microesferas
Monócitos/imunologia
Nanopartículas
Fagocitose/imunologia
Baço/citologia
Baço/imunologia
Toxoides/imunologia
Coqueluche/prevenção & controle
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antigens, Bacterial); 0 (Immunoglobulin G); 0 (Interleukin-17); 0 (Toxoids); 0 (pertussis toxoid); 0 (polylactic acid-polyglycolic acid copolymer); 26009-03-0 (Polyglycolic Acid); 33X04XA5AT (Lactic Acid); 82115-62-6 (Interferon-gamma)
[Em] Mês de entrada:1704
[Cu] Atualização por classe:170417
[Lr] Data última revisão:
170417
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160903
[St] Status:MEDLINE


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[PMID]:27364096
[Au] Autor:Voysey M; Kandasamy R; Yu LM; Baudin M; Sadorge C; Thomas S; John T; Pollard AJ
[Ad] Endereço:Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; Oxford Vaccine Group, Department of Paediatrics, University of Oxford, and NIHR Oxford Biomedical Research Centre, Oxford, UK. Electronic address: Merryn.voysey@phc.ox.ac.uk.
[Ti] Título:The predicted persistence and kinetics of antibody decline 9years after pre-school booster vaccination in UK children.
[So] Source:Vaccine;34(35):4221-4228, 2016 Jul 29.
[Is] ISSN:1873-2518
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Long term follow-up of vaccine trials is essential to establish the duration of protection. In the context of worldwide concern about rising pertussis incidence, estimates of antibody persistence after vaccination, which do not account for the rise in antibody due to natural boosting or infection, may overestimate the degree of protection afforded by pertussis vaccines. METHODS: This was a 5year follow up study of a randomised controlled trial of diphtheria, tetanus, pertussis and polio booster vaccines in UK children aged 3.5-5years. Antibody persistence was measured at 1month, 1, 3, and 5years after vaccination and the kinetics of antibody decline were modelled longitudinally. Estimates of predicted antibody persistence 9years after the pre-school booster were derived from model parameters. RESULTS: Antibody levels 9years after vaccination were predicted to be above accepted thresholds for protection for diphtheria, tetanus and polio. Antibody responses to pertussis toxoid were undetectable in 49% of children at the 5year follow up visit, and responses were predicted to be undetectable in 69% (95% CI 45-88%) of children by the time of their teenage booster at 13-14years of age. CONCLUSIONS: There is no defined correlate of protection for pertussis. However, the large proportion of participants in this study with undetectable pertussis antibody levels at both measured and predicted timepoints suggests sub-optimal immunity in adolescence. Adding pertussis to the teenage booster for UK children as is done in other countries, would enhance immunity in adolescence.
[Mh] Termos MeSH primário: Vacina contra Difteria, Tétano e Coqueluche/uso terapêutico
Vacinas contra Difteria, Tétano e Coqueluche Acelular/uso terapêutico
Imunização Secundária
Vacina Antipólio de Vírus Inativado/uso terapêutico
Vacina Antipólio Oral/uso terapêutico
[Mh] Termos MeSH secundário: Adolescente
Anticorpos Antibacterianos/sangue
Anticorpos Antivirais/sangue
Formação de Anticorpos
Criança
Pré-Escolar
Vacina contra Difteria, Tétano e Coqueluche/administração & dosagem
Vacinas contra Difteria, Tétano e Coqueluche Acelular/administração & dosagem
Feminino
Seguimentos
Seres Humanos
Cinética
Masculino
Vacina Antipólio de Vírus Inativado/administração & dosagem
Vacina Antipólio Oral/administração & dosagem
Toxoides/imunologia
Reino Unido
Vacinas Combinadas/administração & dosagem
Vacinas Combinadas/uso terapêutico
[Pt] Tipo de publicação:JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Antibodies, Bacterial); 0 (Antibodies, Viral); 0 (DTPP vaccine); 0 (Diphtheria-Tetanus-Pertussis Vaccine); 0 (Diphtheria-Tetanus-acellular Pertussis Vaccines); 0 (Poliovirus Vaccine, Inactivated); 0 (Poliovirus Vaccine, Oral); 0 (Toxoids); 0 (Vaccines, Combined); 0 (adacel); 0 (pertussis toxoid)
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171108
[Lr] Data última revisão:
171108
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160702
[St] Status:MEDLINE


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[PMID]:27118519
[Au] Autor:Ma Y
[Ad] Endereço:a Department of Biochemistry and Molecular Biology, Molecular Medicine and Cancer Research Center , Chongqing Medical University , Chongqing , China.
[Ti] Título:Recent advances in nontoxic Escherichia coli heat-labile toxin and its derivative adjuvants.
[So] Source:Expert Rev Vaccines;15(11):1361-1371, 2016 Nov.
[Is] ISSN:1744-8395
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:INTRODUCTION: The nontoxic heat-labile enterotoxin (LT) of Escherichia coli and the B subunit of LT (LTB) have been extensively studied as potent vaccine adjuvants. Areas covered: This review covers the area of enterotoxin based vaccine adjuvant and summarizes the development of nontoxic LT mutant (mLT) and LTB and their potency as oral, parenteral and injection adjuvants. Recent evidences indicated that the mechanism of LTB adjuvanticity was to enhance the turnover of dendritic cells (DCs) in spleen and increase DCs capacity to perform as antigen presentation cells (APCs) encountered with T cells. LTB also induces B and T cells clustering and delay/arrest in T-cell division following endocytosis or B-cell receptor (BCR) uptaking of antigen in a ganglioside-mediated manner. Expert commentary: It is pointed out that the immunogenicity of LTB (or LT) is more important than the receptor binding property (or ADP-ribosylation activity) for the adjuvanticity of LT toxoid. The immunogenicity of LTB (or LT) might confer unknown characteristics to maintain LT toxoid adjuvanticity.
[Mh] Termos MeSH primário: Adjuvantes Imunológicos/administração & dosagem
Toxinas Bacterianas/administração & dosagem
Enterotoxinas/administração & dosagem
Proteínas de Escherichia coli/administração & dosagem
Toxoides/administração & dosagem
[Mh] Termos MeSH secundário: Imunidade Adaptativa
Animais
Linfócitos B/imunologia
Toxinas Bacterianas/genética
Células Dendríticas/efeitos dos fármacos
Células Dendríticas/imunologia
Enterotoxinas/genética
Proteínas de Escherichia coli/genética
Seres Humanos
Proteínas Recombinantes/administração & dosagem
Linfócitos T/imunologia
Toxoides/genética
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Adjuvants, Immunologic); 0 (Bacterial Toxins); 0 (Enterotoxins); 0 (Escherichia coli Proteins); 0 (Recombinant Proteins); 0 (Toxoids); 0 (heat-labile enterotoxin, E coli)
[Em] Mês de entrada:1707
[Cu] Atualização por classe:170731
[Lr] Data última revisão:
170731
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160428
[St] Status:MEDLINE


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[PMID]:27013431
[Au] Autor:de Bruyn G; Saleh J; Workman D; Pollak R; Elinoff V; Fraser NJ; Lefebvre G; Martens M; Mills RE; Nathan R; Trevino M; van Cleeff M; Foglia G; Ozol-Godfrey A; Patel DM; Pietrobon PJ; Gesser R; H-030-012 Clinical Investigator Study Team
[Ad] Endereço:Sanofi Pasteur, Swiftwater, PA, USA. Electronic address: guy.debruyn@sanofipasteur.com.
[Ti] Título:Defining the optimal formulation and schedule of a candidate toxoid vaccine against Clostridium difficile infection: A randomized Phase 2 clinical trial.
[So] Source:Vaccine;34(19):2170-8, 2016 Apr 27.
[Is] ISSN:1873-2518
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Clostridium difficile, a major cause of nosocomial and antibiotic-associated diarrhea, carries a significant disease and cost burden. This study aimed to select an optimal formulation and schedule for a candidate toxoid vaccine against C. difficile toxins A and B. METHODS: Randomized, placebo-controlled, two-stage, Phase 2 study in a total of 661 adults aged 40-75 years. Stage I: low (50 µg antigen) or high (100 µg antigen) dose with or without aluminum hydroxide (AlOH) adjuvant, or placebo, administered on Days 0-7-30. Stage II: Days 0-7-30, 0-7-180, and 0-30-180, using the formulation selected in Stage I through a decision tree defined a priori and based principally on a bootstrap ranking approach. Administration was intramuscular. Blood samples were obtained on Days 0, 7, 14, 30, 60 (Stage I and II), 180, and 210 (Stage II); IgG to toxins A and B was measured by ELISA and in vitro functional activity was measured by toxin neutralizing assay (TNA). Safety data were collected using diary cards. RESULTS: In Stage I the composite immune response against toxins A and B (percentage of participants who seroconverted for both toxins) was highest in the high dose+adjuvant group (97% and 92% for Toxins A and B, respectively) and was chosen for Stage II. In Stage II the immune response profile for this formulation through Day 180 given on Days 0-7-30 ranked above the other two administration schedules. There were no safety issues. CONCLUSIONS: The high dose+adjuvant (100 µg antigen+AlOH) formulation administered at 0-7-30 days elicited the best immune response profile, including functional antibody responses, through Day 180 and was selected for use in subsequent clinical trials.
[Mh] Termos MeSH primário: Vacinas Bacterianas/administração & dosagem
Infecções por Clostridium/prevenção & controle
Esquemas de Imunização
Toxoides/administração & dosagem
[Mh] Termos MeSH secundário: Adjuvantes Imunológicos/administração & dosagem
Adulto
Idoso
Anticorpos Antibacterianos/sangue
Vacinas Bacterianas/efeitos adversos
Vacinas Bacterianas/imunologia
Clostridium difficile
Seres Humanos
Imunoglobulina G/sangue
Meia-Idade
Soroconversão
Toxoides/efeitos adversos
Toxoides/imunologia
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE II; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Adjuvants, Immunologic); 0 (Antibodies, Bacterial); 0 (Bacterial Vaccines); 0 (Immunoglobulin G); 0 (Toxoids)
[Em] Mês de entrada:1610
[Cu] Atualização por classe:161230
[Lr] Data última revisão:
161230
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160326
[St] Status:MEDLINE


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[PMID]:27012151
[Au] Autor:Alimolaei M; Golchin M; Daneshvar H
[Ad] Endereço:Department of Pathobiology, Faculty of Veterinary Medicine, Shahid Bahonar University of Kerman, Kerman, Iran; Department of Anaerobic Bacterial Vaccine Research and Production, Razi Vaccine and Serum Research Institute- Kerman branch, Kerman, Iran.
[Ti] Título:Oral immunization of mice against Clostridium perfringens epsilon toxin with a Lactobacillus casei vector vaccine expressing epsilon toxoid.
[So] Source:Infect Genet Evol;40:282-7, 2016 06.
[Is] ISSN:1567-7257
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:Clostridium perfringens type D infects ruminants and causes the enterotoxemia disease by ε-toxin. A mutated ε-toxin gene lacking toxicity was designed, synthesized, and cloned into the pT1NX vector and electroporated into Lactobacillus casei competent cells to yield LC-pT1NX-ε recombinant strain. BALB/c mice, immunized orally with this strain, highly induced mucosal, humoral, and cell-mediated immune responses and developed a protection against 200 MLD/ml of the activated ε-toxin. This study showed that the LC-pT1NX-ε could be a promising vaccine candidate against the enterotoxemia disease.
[Mh] Termos MeSH primário: Toxinas Bacterianas/imunologia
Vacinas Bacterianas/imunologia
Clostridium perfringens/imunologia
Gangrena Gasosa/prevenção & controle
Vetores Genéticos/imunologia
Lactobacillus casei/imunologia
Toxoides/imunologia
[Mh] Termos MeSH secundário: Administração Oral
Animais
Anticorpos Antibacterianos/sangue
Anticorpos Antibacterianos/imunologia
Toxinas Bacterianas/genética
Vacinas Bacterianas/administração & dosagem
Vacinas Bacterianas/genética
Clostridium perfringens/genética
Citocinas/sangue
Citocinas/metabolismo
Modelos Animais de Doenças
Feminino
Gangrena Gasosa/sangue
Gangrena Gasosa/imunologia
Gangrena Gasosa/mortalidade
Ordem dos Genes
Vetores Genéticos/administração & dosagem
Vetores Genéticos/genética
Imunização
Imunoglobulina A/sangue
Imunoglobulina A/imunologia
Imunoglobulina G/sangue
Imunoglobulina G/imunologia
Lactobacillus casei/genética
Camundongos
Toxoides/administração & dosagem
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Antibodies, Bacterial); 0 (Bacterial Toxins); 0 (Bacterial Vaccines); 0 (Clostridium perfringens epsilon-toxin); 0 (Cytokines); 0 (Immunoglobulin A); 0 (Immunoglobulin G); 0 (Toxoids)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:171104
[Lr] Data última revisão:
171104
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160326
[St] Status:MEDLINE


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[PMID]:26993331
[Au] Autor:Sheldon E; Kitchin N; Peng Y; Eiden J; Gruber W; Johnson E; Jansen KU; Pride MW; Pedneault L
[Ad] Endereço:Miami Research Associates, 6141 Sunset Drive, Suite 501, South Miami, FL 33143, United States.
[Ti] Título:A phase 1, placebo-controlled, randomized study of the safety, tolerability, and immunogenicity of a Clostridium difficile vaccine administered with or without aluminum hydroxide in healthy adults.
[So] Source:Vaccine;34(18):2082-91, 2016 Apr 19.
[Is] ISSN:1873-2518
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:INTRODUCTION: Clostridium difficile is a significant cause of morbidity and mortality in hospitals, nursing homes, and long-term care facilities. The bacteria can produce 3 toxins, of which the C. difficile toxin A and C. difficile toxin B are the principal virulence factors for C. difficile-associated disease. METHODS: A phase 1, first-in-human, placebo-controlled, dose-escalation study was performed to assess the safety and immunogenicity of an investigational vaccine candidate consisting of genetically and chemically detoxified, purified toxins A and B. The toxoids, either alone or in combination with aluminum hydroxide (Al(OH)3), were administered to healthy adults 50-85 years of age at antigen dose levels of 50, 100, or 200 µg in a 3-dose regimen administered at 0, 1, and 6 months. RESULTS: Overall, the C. difficile vaccine formulations and doses administered were generally well tolerated. Local reactions and systemic events were predominantly mild to moderate, were more common in the 50-64-year age cohort, and comprised mostly injection site pain, headache, and fatigue. In subjects who received the vaccine formulations, both the toxin A- and toxin B-specific neutralizing antibody geometric mean concentrations increased substantially at 1 month after Dose 2 and after Dose 3 compared to baseline. In the 50-64-year age cohort, geometric mean fold rises (GMFRs) in toxin A-specific neutralizing antibodies from baseline at Month 7 ranged from 59.19 to 149.23 in the vaccine groups compared to 2.47 in the control group. For toxin-B specific neutralizing antibodies, the GMFRs from baseline at Month 7 ranged from 116.67 to 2503.75 in the vaccine groups compared to 2.48 in the control group. In the 65-85-year age cohort, GMFRs in toxin A-specific neutralizing antibodies from baseline at Month 7 ranged from 42.73 to 254.77 in the vaccine groups compared to 2.03 in the control group. For toxin-B specific neutralizing antibodies, the GMFRs from baseline at Month 7 ranged from 136.12 to 4922.80 in the vaccine groups compared to 1.58 in the control group. Potent antitoxin neutralizing responses were still evident in immunized subjects in both age groups at Month 12. Although there was no clear dose-level response pattern, the data suggest that both the antitoxin A- and B-specific neutralizing responses were trending higher in the toxoid-only groups compared to the toxoid+Al(OH)3 groups. Furthermore, the magnitude of the immune response was similar in the 2 age cohorts. CONCLUSION: The vaccine formulations studied in this phase 1 study were immunogenic and well tolerated. The results presented support further development of the C. difficile vaccine candidate in a larger population of subjects to determine the optimal dose and immunization schedule. CLINICAL TRIAL REGISTRY: NCT01706367.
[Mh] Termos MeSH primário: Adjuvantes Imunológicos/administração & dosagem
Hidróxido de Alumínio/administração & dosagem
Vacinas Bacterianas/uso terapêutico
Enterocolite Pseudomembranosa/prevenção & controle
[Mh] Termos MeSH secundário: Idoso
Idoso de 80 Anos ou mais
Anticorpos Antibacterianos/sangue
Anticorpos Neutralizantes/sangue
Vacinas Bacterianas/administração & dosagem
Clostridium difficile
Feminino
Seres Humanos
Imunização Secundária
Masculino
Meia-Idade
Método Simples-Cego
Toxoides/administração & dosagem
Toxoides/uso terapêutico
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE I; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Adjuvants, Immunologic); 0 (Antibodies, Bacterial); 0 (Antibodies, Neutralizing); 0 (Bacterial Vaccines); 0 (Toxoids); 5QB0T2IUN0 (Aluminum Hydroxide)
[Em] Mês de entrada:1610
[Cu] Atualização por classe:161230
[Lr] Data última revisão:
161230
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160320
[Cl] Clinical Trial:ClinicalTrial
[St] Status:MEDLINE



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