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[PMID]:28460340
[Au] Autor:Medaglini D; Siegrist CA
[Ad] Endereço:Laboratory of Molecular Microbiology and Biotechnology, Department of Medical Biotechnologies, University of Siena, Siena, Italy.
[Ti] Título:Immunomonitoring of human responses to the rVSV-ZEBOV Ebola vaccine.
[So] Source:Curr Opin Virol;23:88-94, 2017 04.
[Is] ISSN:1879-6265
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:The rVSV-ZEBOV vaccine is currently the only Ebola vaccine with demonstrated clinical efficacy in a ring-vaccination clinical trial. It has been shown to be reactogenic but immunogenic and safe in several Phase I clinical studies. However, its mechanisms of protection are unknown and available immunogenicity data are mostly limited to classical serological analysis; it is now of paramount importance to apply cutting-edge technologies, including transcriptomic and metabolomic analyses, and to perform integrative analyses with standard serology and clinical data to comprehensively profile the rVSV-ZEBOV immune signature.
[Mh] Termos MeSH primário: Vacinas contra Ebola/imunologia
Ebolavirus/imunologia
Doença pelo Vírus Ebola/prevenção & controle
[Mh] Termos MeSH secundário: Portadores de Fármacos
Vacinas contra Ebola/administração & dosagem
Perfilação da Expressão Gênica
Seres Humanos
Imunoensaio
Metaboloma
Vacinas Sintéticas/administração & dosagem
Vacinas Sintéticas/imunologia
Vesiculovirus/genética
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Drug Carriers); 0 (Ebola Vaccines); 0 (Vaccines, Synthetic)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180226
[Lr] Data última revisão:
180226
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170502
[St] Status:MEDLINE


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[PMID]:29084758
[Au] Autor:Plummer FA; Jones SM
[Ad] Endereço:Department of Medical Microbiology (Plummer), University of Manitoba College of Medicine, Winnipeg, Man.; Cognoveritas Consulting (Jones), Winnipeg, Man. frankplummer@hotmail.com.
[Ti] Título:The story of Canada's Ebola vaccine.
[So] Source:CMAJ;189(43):E1326-E1327, 2017 10 30.
[Is] ISSN:1488-2329
[Cp] País de publicação:Canada
[La] Idioma:eng
[Mh] Termos MeSH primário: Vacinas contra Ebola
Doença pelo Vírus Ebola
[Mh] Termos MeSH secundário: Canadá
Seres Humanos
[Pt] Tipo de publicação:JOURNAL ARTICLE; COMMENT
[Nm] Nome de substância:
0 (Ebola Vaccines)
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171113
[Lr] Data última revisão:
171113
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:171101
[St] Status:MEDLINE
[do] DOI:10.1503/cmaj.170704


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[PMID]:29020589
[Au] Autor:Kennedy SB; Bolay F; Kieh M; Grandits G; Badio M; Ballou R; Eckes R; Feinberg M; Follmann D; Grund B; Gupta S; Hensley L; Higgs E; Janosko K; Johnson M; Kateh F; Logue J; Marchand J; Monath T; Nason M; Nyenswah T; Roman F; Stavale E; Wolfson J; Neaton JD; Lane HC; PREVAIL I Study Group
[Ad] Endereço:From the Liberian Ministry of Health, Monrovia, Liberia (S.B.K., F.B., M.K., M.B., M.J., F.K., T.N.); the University of Minnesota, Division of Biostatistics, Minneapolis (G.G., B.G., J.W., J.D.N.); GlaxoSmithKline, Rockville (R.B.), and National Institutes of Health (R.E., D.F., L.H., E.H., M.N., H.
[Ti] Título:Phase 2 Placebo-Controlled Trial of Two Vaccines to Prevent Ebola in Liberia.
[So] Source:N Engl J Med;377(15):1438-1447, 2017 10 12.
[Is] ISSN:1533-4406
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: The safety and efficacy of vaccines to prevent Ebola virus disease (EVD) were unknown when the incidence of EVD was peaking in Liberia. METHODS: We initiated a randomized, placebo-controlled, phase 3 trial of the chimpanzee adenovirus 3 vaccine (ChAd3-EBO-Z) and the recombinant vesicular stomatitis virus vaccine (rVSV∆G-ZEBOV-GP) in Liberia. A phase 2 subtrial was embedded to evaluate safety and immunogenicity. Because the incidence of EVD declined in Liberia, the phase 2 component was expanded and the phase 3 component was eliminated. RESULTS: A total of 1500 adults underwent randomization and were followed for 12 months. The median age of the participants was 30 years; 36.6% of the participants were women. During the week after the administration of vaccine or placebo, adverse events occurred significantly more often with the active vaccines than with placebo; these events included injection-site reactions (in 28.5% of the patients in the ChAd3-EBO-Z group and 30.9% of those in the rVSV∆G-ZEBOV-GP group, as compared with 6.8% of those in the placebo group), headache (in 25.1% and 31.9%, vs. 16.9%), muscle pain (in 22.3% and 26.9%, vs. 13.3%), feverishness (in 23.9% and 30.5%, vs. 9.0%), and fatigue (in 14.0% and 15.4%, vs. 8.8%) (P<0.001 for all comparisons); these differences were not seen at 1 month. Serious adverse events within 12 months after injection were seen in 40 participants (8.0%) in the ChAd3-EBO-Z group, in 47 (9.4%) in the rVSV∆G-ZEBOV-GP group, and in 59 (11.8%) in the placebo group. By 1 month, an antibody response developed in 70.8% of the participants in the ChAd3-EBO-Z group and in 83.7% of those in the rVSV∆G-ZEBOV-GP group, as compared with 2.8% of those in the placebo group (P<0.001 for both comparisons). At 12 months, antibody responses in participants in the ChAd3-EBO-Z group (63.5%) and in those in the rVSV∆G-ZEBOV-GP group (79.5%) remained significantly greater than in those in the placebo group (6.8%, P<0.001 for both comparisons). CONCLUSIONS: A randomized, placebo-controlled phase 2 trial of two vaccines that was rapidly initiated and completed in Liberia showed the capability of conducting rigorous research during an outbreak. By 1 month after vaccination, the vaccines had elicited immune responses that were largely maintained through 12 months. (Funded by the National Institutes of Allergy and Infectious Diseases and the Liberian Ministry of Health; PREVAIL I ClinicalTrials.gov number, NCT02344407 .).
[Mh] Termos MeSH primário: Vacinas contra Ebola/efeitos adversos
Vacinas contra Ebola/imunologia
Ebolavirus/imunologia
Doença pelo Vírus Ebola/prevenção & controle
[Mh] Termos MeSH secundário: Adenoviridae
Adulto
Animais
Surtos de Doenças
Método Duplo-Cego
Feminino
Febre/etiologia
Soropositividade para HIV/complicações
Cefaleia/etiologia
Doença pelo Vírus Ebola/complicações
Doença pelo Vírus Ebola/imunologia
Seres Humanos
Injeções Intramusculares/efeitos adversos
Libéria
Masculino
Mialgia/etiologia
Pan troglodytes
RNA Viral/sangue
Reação em Cadeia da Polimerase Via Transcriptase Reversa
Vesiculovirus
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE II; COMPARATIVE STUDY; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Ebola Vaccines); 0 (RNA, Viral)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171019
[Lr] Data última revisão:
171019
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:171012
[Cl] Clinical Trial:ClinicalTrial
[St] Status:MEDLINE
[do] DOI:10.1056/NEJMoa1614067


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[PMID]:28985239
[Au] Autor:Agnandji ST; Fernandes JF; Bache EB; Obiang Mba RM; Brosnahan JS; Kabwende L; Pitzinger P; Staarink P; Massinga-Loembe M; Krähling V; Biedenkopf N; Fehling SK; Strecker T; Clark DJ; Staines HM; Hooper JW; Silvera P; Moorthy V; Kieny MP; Adegnika AA; Grobusch MP; Becker S; Ramharter M; Mordmüller B; Lell B; Krishna S; Kremsner PG; VEBCON Consortium
[Ad] Endereço:Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon.
[Ti] Título:Safety and immunogenicity of rVSVΔG-ZEBOV-GP Ebola vaccine in adults and children in Lambaréné, Gabon: A phase I randomised trial.
[So] Source:PLoS Med;14(10):e1002402, 2017 Oct.
[Is] ISSN:1549-1676
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: The rVSVΔG-ZEBOV-GP vaccine prevented Ebola virus disease when used at 2 × 107 plaque-forming units (PFU) in a trial in Guinea. This study provides further safety and immunogenicity data. METHODS AND FINDINGS: A randomised, open-label phase I trial in Lambaréné, Gabon, studied 5 single intramuscular vaccine doses of 3 × 103, 3 × 104, 3 × 105, 3 × 106, or 2 × 107 PFU in 115 adults and a dose of 2 × 107 PFU in 20 adolescents and 20 children. The primary objective was safety and tolerability 28 days post-injection. Immunogenicity, viraemia, and shedding post-vaccination were evaluated as secondary objectives. In adults, mild-to-moderate adverse events were frequent, but there were no serious or severe adverse events related to vaccination. Before vaccination, Zaire Ebola virus (ZEBOV)-glycoprotein (GP)-specific and ZEBOV antibodies were detected in 11% and 27% of adults, respectively. In adults, 74%-100% of individuals who received a dose 3 × 104, 3 × 105, 3 × 106, or 2 × 107 PFU had a ≥4.0-fold increase in geometric mean titres (GMTs) of ZEBOV-GP-specific antibodies at day 28, reaching GMTs of 489 (95% CI: 264-908), 556 (95% CI: 280-1,101), 1,245 (95% CI: 899-1,724), and 1,503 (95% CI: 931-2,426), respectively. Twenty-two percent of adults had a ≥4-fold increase of ZEBOV antibodies, with GMTs at day 28 of 1,015 (647-1,591), 1,887 (1,154-3,085), 1,445 (1,013-2,062), and 3,958 (2,249-6,967) for the same doses, respectively. These antibodies persisted up to day 180 for doses ≥3 × 105 PFU. Adults with antibodies before vaccination had higher GMTs throughout. Neutralising antibodies were detected in more than 50% of participants at doses ≥3 × 105 PFU. As in adults, no serious or severe adverse events related to vaccine occurred in adolescents or children. At day 2, vaccine RNA titres were higher for adolescents and children than adults. At day 7, 78% of adolescents and 35% of children had recombinant vesicular stomatitis virus RNA detectable in saliva. The vaccine induced high GMTs of ZEBOV-GP-specific antibodies at day 28 in adolescents, 1,428 (95% CI: 1,025-1,989), and children, 1,620 (95% CI: 806-3,259), and in both groups antibody titres increased up to day 180. The absence of a control group, lack of stratification for baseline antibody status, and imbalances in male/female ratio are the main limitations of this study. CONCLUSIONS: Our data confirm the acceptable safety and immunogenicity profile of the 2 × 107 PFU dose in adults and support consideration of lower doses for paediatric populations and those who request boosting. TRIAL REGISTRATION: Pan African Clinical Trials Registry PACTR201411000919191.
[Mh] Termos MeSH primário: Imunidade Adaptativa/efeitos dos fármacos
Vacinas contra Ebola/administração & dosagem
Ebolavirus/imunologia
Doença pelo Vírus Ebola/prevenção & controle
Imunogenicidade da Vacina
[Mh] Termos MeSH secundário: Adolescente
Adulto
Fatores Etários
Anticorpos Neutralizantes/sangue
Anticorpos Antivirais/sangue
Biomarcadores/sangue
Criança
Vacinas contra Ebola/efeitos adversos
Vacinas contra Ebola/imunologia
Feminino
Gabão
Doença pelo Vírus Ebola/diagnóstico
Doença pelo Vírus Ebola/imunologia
Doença pelo Vírus Ebola/virologia
Seres Humanos
Injeções Intramusculares
Masculino
Meia-Idade
Fatores de Tempo
Resultado do Tratamento
Vacinação
Eliminação de Partículas Virais
Adulto Jovem
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE I; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Antibodies, Neutralizing); 0 (Antibodies, Viral); 0 (Biomarkers); 0 (Ebola Vaccines)
[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:171007
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pmed.1002402


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[PMID]:28719299
[Au] Autor:Larson GS; Baseler BR; Hoover ML; Pierson JF; Tegli JK; Johnson MP; Kieh MWS; McNay LA; Njoh WS
[Ad] Endereço:Coordinating Centers for Biometric Research, Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota.
[Ti] Título:Conventional Wisdom versus Actual Outcomes: Challenges in the Conduct of an Ebola Vaccine Trial in Liberia during the International Public Health Emergency.
[So] Source:Am J Trop Med Hyg;97(1):10-15, 2017 Jul.
[Is] ISSN:1476-1645
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Clinical trials are challenging endeavors. Planning and implementing an investigational vaccine trial in Liberia, in the midst of an Ebola virus disease (EVD) epidemic that World Health Organization classified a public health emergency of international concern, presented extraordinary challenges. Normally, years of preparation and a litany of tasks lay the groundwork for a successful, randomized, blinded, placebo-controlled trial focused on safety and efficacy. Difficult research settings, unpredictable events, and other unique circumstances can add complexity. The setting in Liberia was especially problematic due to an infrastructure still badly damaged following a lengthy civil war and a very fragile health-care system that was further devastated by the EVD outbreak. The Partnership for Research on Vaccines in Liberia I EVD vaccine trial was planned and implemented in less than 3 months by a Liberian and U.S. research partnership, and its Phase II substudy was fully enrolled 3 months later. Contrasting conventional wisdom with trial outcomes offers an opportunity to compare early assumptions, barriers encountered, and adaptive strategies used, with end results. Understanding what was learned can inform future trial responses when disease outbreaks, especially in resource-poor locations with minimal infrastructure, pose a significant threat to public health.
[Mh] Termos MeSH primário: Pesquisa Biomédica/organização & administração
Ensaios Clínicos como Assunto
Surtos de Doenças/prevenção & controle
Vacinas contra Ebola
Epidemias/prevenção & controle
Doença pelo Vírus Ebola/epidemiologia
Doença pelo Vírus Ebola/prevenção & controle
[Mh] Termos MeSH secundário: Seres Humanos
Cooperação Internacional
Libéria/epidemiologia
Saúde Pública/métodos
Projetos de Pesquisa
Estados Unidos
Organização Mundial da Saúde
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Ebola Vaccines)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170821
[Lr] Data última revisão:
170821
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170719
[St] Status:MEDLINE
[do] DOI:10.4269/ajtmh.16-1015


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[PMID]:28630358
[Au] Autor:ElSherif MS; Brown C; MacKinnon-Cameron D; Li L; Racine T; Alimonti J; Rudge TL; Sabourin C; Silvera P; Hooper JW; Kwilas SA; Kilgore N; Badorrek C; Ramsey WJ; Heppner DG; Kemp T; Monath TP; Nowak T; McNeil SA; Langley JM; Halperin SA; Canadian Immunization Research Network
[Ad] Endereço:Canadian Center for Vaccinology (ElSherif, Brown, MacKinnon-Cameron, Li, McNeil, Langley, Halperin), IWK Health Centre and Nova Scotia Health Authority, Dalhousie University, Halifax, NS; National Microbiology Laboratory (Racine, Alimonti), Winnipeg, Man.; Battelle Biomedical Research Center (Rudge,
[Ti] Título:Assessing the safety and immunogenicity of recombinant vesicular stomatitis virus Ebola vaccine in healthy adults: a randomized clinical trial.
[So] Source:CMAJ;189(24):E819-E827, 2017 Jun 19.
[Is] ISSN:1488-2329
[Cp] País de publicação:Canada
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: The 2013-2016 Ebola virus outbreak in West Africa was the most widespread in history. In response, alive attenuated recombinant vesicular stomatitis virus (rVSV) vaccine expressing glycoprotein (rVSVΔG-ZEBOV-GP) was evaluated in humans. METHODS: In a phase 1, randomized, dose-ranging, observer-blind, placebo-controlled trial, healthy adults aged 18-65 years were randomized into 4 groups of 10 to receive one of 3 vaccine doses or placebo. Follow-up visits spanned 180 days postvaccination for safety monitoring, immunogenicity testing and any rVSV virus shedding. RESULTS: Forty participants were injected with rVSVΔG-ZEBOV-GP vaccine ( = 30) or saline placebo ( = 10). No serious adverse events related to the vaccine or participant withdrawals were reported. Solicited adverse events during the 14-day follow-up period were mild to moderate and self-limited, with the exception of injection-site pain and headache. Viremia following vaccination was transient and no longer detectable after study day 3, with no virus shedding in saliva or urine. All vaccinated participants developed serum immunoglobulin G (IgG), as measured by Ebola virus envelope glycoprotein-based enzyme-linked immunosorbent assay (ELISA). Immunogenicity was comparable across all dose groups, and sustained IgG titers were detectable through to the last visit, at study day 180. INTERPRETATION: In this phase 1 study, there were no safety concerns after a single dose of rVSVΔG-ZEBOV-GP vaccine. IgG ELISA showed persistent high titers at 180 days postimmunization. There was a period of reactogenicity, but in general, the vaccine was well tolerated. This study provides evidence of the safety and immunogenicity of rVSVΔG-ZEBOV-GP vaccine and importance of its further investigation. Clinical-Trials.gov no., NCT02374385.
[Mh] Termos MeSH primário: Vacinas contra Ebola/administração & dosagem
Doença pelo Vírus Ebola/prevenção & controle
Glicoproteínas de Membrana/imunologia
Proteínas do Envelope Viral/imunologia
[Mh] Termos MeSH secundário: Adolescente
Adulto
Animais
Anticorpos Neutralizantes/sangue
Anticorpos Antivirais/sangue
Canadá
Método Duplo-Cego
Ebolavirus
Feminino
Voluntários Saudáveis
Seres Humanos
Imunoglobulina G/sangue
Masculino
Glicoproteínas de Membrana/genética
Meia-Idade
Análise de Regressão
Vacinação/métodos
Vacinas Sintéticas/administração & dosagem
Vírus da Estomatite Vesicular Indiana
Proteínas do Envelope Viral/genética
Adulto Jovem
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE I; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Antibodies, Neutralizing); 0 (Antibodies, Viral); 0 (Ebola Vaccines); 0 (G protein, vesicular stomatitis virus); 0 (Immunoglobulin G); 0 (Membrane Glycoproteins); 0 (Vaccines, Synthetic); 0 (Viral Envelope Proteins)
[Em] Mês de entrada:1707
[Cu] Atualização por classe:171110
[Lr] Data última revisão:
171110
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170621
[St] Status:MEDLINE
[do] DOI:10.1503/cmaj.170074


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[PMID]:28606591
[Au] Autor:Heppner DG; Kemp TL; Martin BK; Ramsey WJ; Nichols R; Dasen EJ; Link CJ; Das R; Xu ZJ; Sheldon EA; Nowak TA; Monath TP; V920-004 study team
[Ad] Endereço:Bioprotection Systems, NewLink Genetics, Ames, IA, USA; Devens, MA, USA. Electronic address: grayheppner@gmail.com.
[Ti] Título:Safety and immunogenicity of the rVSV∆G-ZEBOV-GP Ebola virus vaccine candidate in healthy adults: a phase 1b randomised, multicentre, double-blind, placebo-controlled, dose-response study.
[So] Source:Lancet Infect Dis;17(8):854-866, 2017 Aug.
[Is] ISSN:1474-4457
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: The 2014 Zaire Ebola virus outbreak highlighted the need for a safe, effective vaccine with a rapid onset of protection. We report the safety and immunogenicity of the recombinant vesicular stomatitis virus-Zaire Ebola virus envelope glycoprotein vaccine (rVSV∆G-ZEBOV-GP) across a 6 log dose range in two sequential cohorts. METHODS: In this phase 1b double-blind, placebo-controlled, dose-response study we enrolled and randomly assigned healthy adults (aged 18-61 years) at eight study sites in the USA to receive a single injection of vaccine or placebo, administered by intramuscular injection. In cohort 1, participants were assigned to receive 3 × 10 , 3 × 10 , 3 × 10 , or 3 × 10 PFU doses of rVSV∆G-ZEBOV-GP or placebo. In cohort 2, participants were assigned to receive 3 × 10 , 9 × 10 , 2 × 10 , or 1 × 10 PFU doses of rVSV∆G-ZEBOV-GP or placebo. Participants were centrally allocated by the study statistician to vaccine groups or placebo through computer-generated randomisation lists. The primary safety outcome was incidence of adverse events within 14 days in the modified intention-to-treat population (all randomly assigned participants who received vaccine or placebo), and the primary outcome for immunogenicity was IgG ELISA antibody titres at day 28 in the per-protocol population. Surveillance was enhanced for arthritis and dermatitis through to day 56. This study is registered with ClinicalTrials.gov, number NCT02314923. FINDINGS: Between Dec 26, 2014, and June 8, 2015, 513 participants were enrolled and randomly assigned; one was not immunised because of unsuccessful phlebotomy. In cohort 1, 256 participants received vaccine (3 × 10 [n=64], 3 × 10 [n=64], 3 × 10 [n=64], or 3 × 10 PFU [n=64]) and 74 received placebo. In cohort 2, 162 participants received vaccine (3 × 10 [n=20], 9 × 10 [n=47], 2 × 10 [n=47], or 1 × 10 PFU [n=48]) and 20 received placebo. Most adverse events occurred in the first day after vaccination, and were mild to moderate in intensity, of a short duration, and more frequent at high vaccine doses (9 × 10 PFU and greater). At the 2 × 10 PFU dose (used in phase 3 trials), the most common local adverse events versus placebo within the first 14 days were arm pain (57·4% [27 of 47] vs 7·4% [seven of 94]) and local tenderness (59·6% [28 of 47] vs 8·5% [eight of 94]). The most common systemic adverse events at the 2 × 10 PFU dose versus placebo, occurring in the first 14 days, were headache (46·8% [22 of 47] vs 27·7% [26 of 94]), fatigue (38·3% [18 of 47] vs 19·1% [18 of 94]), myalgia (34·0% [16 of 47] vs 10·6% [10 of 94]), subjective fever (29·8% [14 of 47] vs 2·1% [two of 94]), shivering or chills (27·7% [13 of 47] vs 7·4% [seven of 94]), sweats (23·4% [11 of 47] vs 3·2% [three of 94]), joint aches and pain (19·1% [nine of 47] vs 7·4% [seven of 94]), objective fever (14·9% [seven of 47] vs 1·1% [one of 94]), and joint tenderness or swelling (14·9% [seven of 47] vs 2·1% [two of 94]). Self-limited, post-vaccination arthritis occurred in 4·5% (19 of 418) of vaccinees (median onset 12·0 days [IQR 10-14]; median duration 8·0 days [6-15]) versus 3·2% (three of 94) of controls (median onset 15·0 days [6-20]; median duration 47·0 days [37-339]), with no apparent dose relationship. Post-vaccination dermatitis occurred in 5·7% (24 of 418) of vaccinees (median onset 9·0 days [IQR 2-12]; median duration 7·0 days [4-9]) versus 3·2% (three of 94) of controls (median onset 5·0 days [3-53]; median duration 33·0 days [5-370]). A low-level, transient, dose-dependent viraemia occurred in concert with early reactogenicity. Antibody responses were observed in most participants by day 14. IgG and neutralising antibody titres were dose-related (p=0·0003 for IgG ELISA and p<0·0001 for the 60% plaque-reduction neutralisation test [PRNT60] by linear trend). On day 28 at the 2 × 10 PFU dose, the geometric mean IgG ELISA endpoint titre was 1624 (95% CI 1146-2302) and seroconversion was 95·7% (95% CI 85·5-98·8); the geometric mean neutralising antibody titre by PRNT60 was 250 (176-355) and seroconversion was 95·7% (85·5-98·8). These robust immunological responses were sustained for 1 year. INTERPRETATION: rVSV∆G-ZEBOV-GP was well tolerated and stimulated a rapid onset of binding and neutralising antibodies, which were maintained through to day 360. The immunogenicity results support selection of the 2 × 10 PFU dose. FUNDING: Biomedical Advanced Research and Development Authority, US Department of Health and Human Services.
[Mh] Termos MeSH primário: Vacinas contra Ebola/efeitos adversos
Vacinas contra Ebola/imunologia
Doença pelo Vírus Ebola/prevenção & controle
[Mh] Termos MeSH secundário: Adolescente
Adulto
Anticorpos Neutralizantes/sangue
Anticorpos Antivirais/sangue
Método Duplo-Cego
Portadores de Fármacos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/patologia
Vacinas contra Ebola/administração & dosagem
Vacinas contra Ebola/genética
Ebolavirus/genética
Ebolavirus/imunologia
Ensaio de Imunoadsorção Enzimática
Feminino
Vetores Genéticos
Voluntários Saudáveis
Seres Humanos
Imunoglobulina G/sangue
Incidência
Injeções Intramusculares
Masculino
Meia-Idade
Testes de Neutralização
Placebos/administração & dosagem
Estados Unidos
Vacinas Sintéticas/administração & dosagem
Vacinas Sintéticas/efeitos adversos
Vacinas Sintéticas/genética
Vacinas Sintéticas/imunologia
Vesiculovirus/genética
Proteínas do Envelope Viral/genética
Proteínas do Envelope Viral/imunologia
Ensaio de Placa Viral
Adulto Jovem
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE I; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Antibodies, Neutralizing); 0 (Antibodies, Viral); 0 (Drug Carriers); 0 (Ebola Vaccines); 0 (Immunoglobulin G); 0 (Placebos); 0 (Vaccines, Synthetic); 0 (Viral Envelope Proteins)
[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:170614
[St] Status:MEDLINE


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[PMID]:28549145
[Au] Autor:Halperin SA; Arribas JR; Rupp R; Andrews CP; Chu L; Das R; Simon JK; Onorato MT; Liu K; Martin J; Helmond FA; V920-012 Study Team
[Ad] Endereço:Canadian Center for Vaccinology, Dalhousie University, IWK Health Centre, and Nova Scotia Health Authority, Halifax, Canada.
[Ti] Título:Six-Month Safety Data of Recombinant Vesicular Stomatitis Virus-Zaire Ebola Virus Envelope Glycoprotein Vaccine in a Phase 3 Double-Blind, Placebo-Controlled Randomized Study in Healthy Adults.
[So] Source:J Infect Dis;215(12):1789-1798, 2017 Jun 15.
[Is] ISSN:1537-6613
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Background: This study (NCT02503202) evaluated the safety of recombinant vesicular stomatitis virus-Zaire Ebola virus envelope glycoprotein vaccine (rVSVΔG-ZEBOV-GP). Methods: Overall, 1197 subjects were randomized 2:2:2:2:1; 1194 were vaccinated with 1 dose of 1 of 3 lots of rVSVΔG- ZEBOV-GP (2 × 107 plaque-forming units [pfu], n = 797; combined-lots group), a single high-dose lot of rVSVΔG-ZEBOV-GP (1 × 108 pfu, n = 264; high-dose group), or placebo (n = 133). Daily temperatures and adverse events (AEs) were recorded days 1 to 42 postvaccination. Solicited AEs included injection-site AEs from days 1 to 5, and joint pain, joint swelling, vesicular lesions (blisters), and rashes from days 1 to 42. Serious AEs (SAEs) were recorded through 6 months postvaccination. Results: Fever (≥38.0°C) was observed in 20.2% of combined lots (3.2% with ≥39.0°C), 32.2% of high-dose (4.3% with ≥39.0°C), and 0.8% of placebo (0.8% with ≥39.0°C). Incidences of AEs of interest (days 1-42) were arthralgia (17.1% combined lots, 20.4% high-dose, 3.0% placebo), arthritis (5.1% combined lots, 4.2% high-dose, 0.0% placebo), and rash (3.8% combined lots, 3.8% high-dose, 1.5% placebo). Twenty-one SAEs and 2 deaths were reported, all assessed by investigators as unrelated to vaccine. Conclusions: rVSVΔG-ZEBOV-GP was generally well-tolerated, with increased rates of injection-site and systemic AEs compared to placebo, and no vaccine-related SAEs or deaths. These findings support the use of rVSVΔG-ZEBOV-GP vaccine in persons at risk for Ebola virus disease. Clinical Trials Registration: NCT02503202.
[Mh] Termos MeSH primário: Vacinas contra Ebola/efeitos adversos
Ebolavirus/imunologia
Doença pelo Vírus Ebola/prevenção & controle
Estomatite Vesicular/imunologia
Proteínas do Envelope Viral/imunologia
[Mh] Termos MeSH secundário: Adolescente
Adulto
Idoso
Método Duplo-Cego
Vacinas contra Ebola/imunologia
Feminino
Voluntários Saudáveis/estatística & dados numéricos
Seres Humanos
Masculino
Meia-Idade
Vacinação/métodos
Vacinas Sintéticas/efeitos adversos
Vacinas Sintéticas/imunologia
Proteínas do Envelope Viral/efeitos adversos
Adulto Jovem
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE III; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Ebola Vaccines); 0 (Vaccines, Synthetic); 0 (Viral Envelope Proteins); 0 (envelope glycoprotein, Ebola virus)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:170907
[Lr] Data última revisão:
170907
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170527
[St] Status:MEDLINE
[do] DOI:10.1093/infdis/jix189


  9 / 385 MEDLINE  
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[PMID]:28525756
[Au] Autor:Zhao X; Howell KA; He S; Brannan JM; Wec AZ; Davidson E; Turner HL; Chiang CI; Lei L; Fels JM; Vu H; Shulenin S; Turonis AN; Kuehne AI; Liu G; Ta M; Wang Y; Sundling C; Xiao Y; Spence JS; Doranz BJ; Holtsberg FW; Ward AB; Chandran K; Dye JM; Qiu X; Li Y; Aman MJ
[Ad] Endereço:Institute for Bioscience and Biotechnology Research, University of Maryland, Rockville, MD 20878, USA.
[Ti] Título:Immunization-Elicited Broadly Protective Antibody Reveals Ebolavirus Fusion Loop as a Site of Vulnerability.
[So] Source:Cell;169(5):891-904.e15, 2017 May 18.
[Is] ISSN:1097-4172
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:While neutralizing antibodies are highly effective against ebolavirus infections, current experimental ebolavirus vaccines primarily elicit species-specific antibody responses. Here, we describe an immunization-elicited macaque antibody (CA45) that clamps the internal fusion loop with the N terminus of the ebolavirus glycoproteins (GPs) and potently neutralizes Ebola, Sudan, Bundibugyo, and Reston viruses. CA45, alone or in combination with an antibody that blocks receptor binding, provided full protection against all pathogenic ebolaviruses in mice, guinea pigs, and ferrets. Analysis of memory B cells from the immunized macaque suggests that elicitation of broadly neutralizing antibodies (bNAbs) for ebolaviruses is possible but difficult, potentially due to the rarity of bNAb clones and their precursors. Unexpectedly, germline-reverted CA45, while exhibiting negligible binding to full-length GP, bound a proteolytically remodeled GP with picomolar affinity, suggesting that engineered ebolavirus vaccines could trigger rare bNAb precursors more robustly. These findings have important implications for developing pan-ebolavirus vaccine and immunotherapeutic cocktails.
[Mh] Termos MeSH primário: Anticorpos Neutralizantes/imunologia
Anticorpos Neutralizantes/isolamento & purificação
Anticorpos Antivirais/imunologia
Anticorpos Antivirais/isolamento & purificação
Vacinas contra Ebola/imunologia
Doença pelo Vírus Ebola/imunologia
[Mh] Termos MeSH secundário: Sequência de Aminoácidos
Animais
Anticorpos Neutralizantes/química
Anticorpos Antivirais/química
Regiões Determinantes de Complementaridade
Reações Cruzadas
Ebolavirus/imunologia
Mapeamento de Epitopos
Epitopos de Linfócito B/imunologia
Feminino
Furões
Cobaias
Fragmentos Fab das Imunoglobulinas/ultraestrutura
Macaca fascicularis
Masculino
Camundongos
Camundongos Endogâmicos BALB C
Modelos Moleculares
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antibodies, Neutralizing); 0 (Antibodies, Viral); 0 (Complementarity Determining Regions); 0 (Ebola Vaccines); 0 (Epitopes, B-Lymphocyte); 0 (Immunoglobulin Fab Fragments)
[Em] Mês de entrada:1707
[Cu] Atualização por classe:170803
[Lr] Data última revisão:
170803
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170520
[St] Status:MEDLINE


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[PMID]:28525755
[Au] Autor:Wec AZ; Herbert AS; Murin CD; Nyakatura EK; Abelson DM; Fels JM; He S; James RM; de La Vega MA; Zhu W; Bakken RR; Goodwin E; Turner HL; Jangra RK; Zeitlin L; Qiu X; Lai JR; Walker LM; Ward AB; Dye JM; Chandran K; Bornholdt ZA
[Ad] Endereço:Department of Microbiology and Immunology, Albert Einstein College of Medicine, Bronx, NY 10461, USA.
[Ti] Título:Antibodies from a Human Survivor Define Sites of Vulnerability for Broad Protection against Ebolaviruses.
[So] Source:Cell;169(5):878-890.e15, 2017 May 18.
[Is] ISSN:1097-4172
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Experimental monoclonal antibody (mAb) therapies have shown promise for treatment of lethal Ebola virus (EBOV) infections, but their species-specific recognition of the viral glycoprotein (GP) has limited their use against other divergent ebolaviruses associated with human disease. Here, we mined the human immune response to natural EBOV infection and identified mAbs with exceptionally potent pan-ebolavirus neutralizing activity and protective efficacy against three virulent ebolaviruses. These mAbs recognize an inter-protomer epitope in the GP fusion loop, a critical and conserved element of the viral membrane fusion machinery, and neutralize viral entry by targeting a proteolytically primed, fusion-competent GP intermediate (GP ) generated in host cell endosomes. Only a few somatic hypermutations are required for broad antiviral activity, and germline-approximating variants display enhanced GP recognition, suggesting that such antibodies could be elicited more efficiently with suitably optimized GP immunogens. Our findings inform the development of both broadly effective immunotherapeutics and vaccines against filoviruses.
[Mh] Termos MeSH primário: Anticorpos Neutralizantes/isolamento & purificação
Anticorpos Antivirais/isolamento & purificação
Vacinas contra Ebola/imunologia
Doença pelo Vírus Ebola/imunologia
Sobreviventes
[Mh] Termos MeSH secundário: Sequência de Aminoácidos
Animais
Anticorpos Monoclonais/química
Anticorpos Monoclonais/imunologia
Anticorpos Neutralizantes/química
Anticorpos Neutralizantes/imunologia
Anticorpos Antivirais/química
Anticorpos Antivirais/imunologia
Cercopithecus aethiops
Reações Cruzadas
Ebolavirus/classificação
Ebolavirus/imunologia
Feminino
Furões
Doença pelo Vírus Ebola/virologia
Seres Humanos
Cinética
Camundongos
Camundongos Endogâmicos BALB C
Modelos Moleculares
Alinhamento de Sequência
Células Vero
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antibodies, Monoclonal); 0 (Antibodies, Neutralizing); 0 (Antibodies, Viral); 0 (Ebola Vaccines)
[Em] Mês de entrada:1707
[Cu] Atualização por classe:170803
[Lr] Data última revisão:
170803
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170520
[St] Status:MEDLINE



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