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Safety and immunogenicity of an inactivated recombinant Newcastle disease virus vaccine expressing SARS-CoV-2 spike: Results of a randomized vaccine-controlled phase I ADAPTCOV trial in Brazil.

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Title: Safety and immunogenicity of an inactivated recombinant Newcastle disease virus vaccine expressing SARS-CoV-2 spike: Results of a randomized vaccine-controlled phase I ADAPTCOV trial in Brazil.
Authors: Peixoto de Miranda ÉJF; Center of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, SP, Brazil., Calado RT; Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP), Ribeirão Preto, SP, Brazil., Boulos FC; Center of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, SP, Brazil., de Sousa Moreira JA; Center of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, SP, Brazil., Machado FF; Center of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, SP, Brazil., Almeida MAALDS; Center of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, SP, Brazil., Da Rocha MCO; Center of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, SP, Brazil., Infante V; Center of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, SP, Brazil., Mercer LD; PATH, Seattle, WA, USA., Hjorth R; PATH, Seattle, WA, USA., Scharf R; PATH, Seattle, WA, USA., White J; PATH, Seattle, WA, USA., Polyak C; PATH, Seattle, WA, USA., Raghunandan R; PATH, Seattle, WA, USA., García-Sastre A; Department of Microbiology, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY, USA; Department of Medicine, Division of Infectious Diseases, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY, USA; Global Health and Emerging Pathogens Institute, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY, USA; The Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY, USA; Department of Pathology, Molecular and Cell-Based Medicine, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY, USA; The Icahn Genomics Center, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY, USA., Sun W; Department of Microbiology, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY, USA., Palese P; Department of Microbiology, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY, USA., Krammer F; Department of Pathology, Molecular and Cell-Based Medicine, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY, USA; Center for Vaccine Research and Pandemic Preparedness (C-VaRPP), Icahn School of Medicine at Mount Sinai, New York, NY, USA; Ignaz Semmelweis Institute, Interuniversity Institute for Infection Research, Medical University of Vienna, Vienna, Austria., Innis B; PATH, Seattle, WA, USA.. Electronic address: binnis@path.org., Pereira CG; Center of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, SP, Brazil., Kallas EG; Center of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, SP, Brazil. Electronic address: esper.kallas@butantan.gov.br.
Source: Vaccine [Vaccine] 2025 Apr 11; Vol. 52, pp. 126680. Date of Electronic Publication: 2025 Mar 03.
Publication Type: Journal Article; Randomized Controlled Trial; Clinical Trial, Phase I; Research Support, Non-U.S. Gov't; Research Support, N.I.H., Extramural
Journal Info: Publisher: Elsevier Science Country of Publication: Netherlands NLM ID: 8406899 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-2518 (Electronic) Linking ISSN: 0264410X NLM ISO Abbreviation: Vaccine Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Safety and immunogenicity of an inactivated recombinant Newcastle disease virus vaccine expressing SARS-CoV-2 spike: Results of a randomized vaccine-controlled phase I ADAPTCOV trial in Brazil.
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  Data: <searchLink fieldCode="AU" term="%22Peixoto+de+Miranda+ÉJF%22">Peixoto de Miranda ÉJF</searchLink>; Center of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, SP, Brazil.<br /><searchLink fieldCode="AU" term="%22Calado+RT%22">Calado RT</searchLink>; Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP), Ribeirão Preto, SP, Brazil.<br /><searchLink fieldCode="AU" term="%22Boulos+FC%22">Boulos FC</searchLink>; Center of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, SP, Brazil.<br /><searchLink fieldCode="AU" term="%22de+Sousa+Moreira+JA%22">de Sousa Moreira JA</searchLink>; Center of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, SP, Brazil.<br /><searchLink fieldCode="AU" term="%22Machado+FF%22">Machado FF</searchLink>; Center of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, SP, Brazil.<br /><searchLink fieldCode="AU" term="%22Almeida+MAALDS%22">Almeida MAALDS</searchLink>; Center of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, SP, Brazil.<br /><searchLink fieldCode="AU" term="%22Da+Rocha+MCO%22">Da Rocha MCO</searchLink>; Center of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, SP, Brazil.<br /><searchLink fieldCode="AU" term="%22Infante+V%22">Infante V</searchLink>; Center of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, SP, Brazil.<br /><searchLink fieldCode="AU" term="%22Mercer+LD%22">Mercer LD</searchLink>; PATH, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22Hjorth+R%22">Hjorth R</searchLink>; PATH, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22Scharf+R%22">Scharf R</searchLink>; PATH, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22White+J%22">White J</searchLink>; PATH, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22Polyak+C%22">Polyak C</searchLink>; PATH, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22Raghunandan+R%22">Raghunandan R</searchLink>; PATH, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22García-Sastre+A%22">García-Sastre A</searchLink>; Department of Microbiology, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY, USA; Department of Medicine, Division of Infectious Diseases, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY, USA; Global Health and Emerging Pathogens Institute, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY, USA; The Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY, USA; Department of Pathology, Molecular and Cell-Based Medicine, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY, USA; The Icahn Genomics Center, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY, USA.<br /><searchLink fieldCode="AU" term="%22Sun+W%22">Sun W</searchLink>; Department of Microbiology, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY, USA.<br /><searchLink fieldCode="AU" term="%22Palese+P%22">Palese P</searchLink>; Department of Microbiology, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY, USA.<br /><searchLink fieldCode="AU" term="%22Krammer+F%22">Krammer F</searchLink>; Department of Pathology, Molecular and Cell-Based Medicine, Icahn School of Medicine at Mount Sinai (ISMMS), New York, NY, USA; Center for Vaccine Research and Pandemic Preparedness (C-VaRPP), Icahn School of Medicine at Mount Sinai, New York, NY, USA; Ignaz Semmelweis Institute, Interuniversity Institute for Infection Research, Medical University of Vienna, Vienna, Austria.<br /><searchLink fieldCode="AU" term="%22Innis+B%22">Innis B</searchLink>; PATH, Seattle, WA, USA.. Electronic address: binnis@path.org.<br /><searchLink fieldCode="AU" term="%22Pereira+CG%22">Pereira CG</searchLink>; Center of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, SP, Brazil.<br /><searchLink fieldCode="AU" term="%22Kallas+EG%22">Kallas EG</searchLink>; Center of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, SP, Brazil. Electronic address: esper.kallas@butantan.gov.br.
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  Data: <searchLink fieldCode="JN" term="%228406899%22">Vaccine</searchLink> [Vaccine] 2025 Apr 11; Vol. 52, pp. 126680. <i>Date of Electronic Publication: </i>2025 Mar 03.
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  Data: Journal Article; Randomized Controlled Trial; Clinical Trial, Phase I; Research Support, Non-U.S. Gov't; Research Support, N.I.H., Extramural
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Elsevier+Science%22">Elsevier Science </searchLink><i>Country of Publication: </i>Netherlands <i>NLM ID: </i>8406899 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1873-2518 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%220264410X%22">0264410X </searchLink><i>NLM ISO Abbreviation: </i>Vaccine <i>Subsets: </i>MEDLINE
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              Text: 2025 Apr 11
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