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
Description
ISSN:1873-2518
DOI:10.1016/j.vaccine.2024.126680