Safety and tolerability of a novel, polyclonal human anti-MERS coronavirus antibody produced from transchromosomic cattle: a phase 1 randomised, double-blind, single-dose-escalation study.
Identifieur interne : 000817 ( Main/Exploration ); précédent : 000816; suivant : 000818Safety and tolerability of a novel, polyclonal human anti-MERS coronavirus antibody produced from transchromosomic cattle: a phase 1 randomised, double-blind, single-dose-escalation study.
Auteurs : John H. Beigel [États-Unis] ; Jocelyn Voell [États-Unis] ; Parag Kumar [États-Unis] ; Kanakatte Raviprakash [États-Unis] ; Hua Wu [États-Unis] ; Jin-An Jiao [États-Unis] ; Eddie Sullivan [États-Unis] ; Thomas Luke [États-Unis] ; Richard T. Davey [États-Unis]Source :
- The Lancet. Infectious diseases [ 1474-4457 ] ; 2018.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Animal génétiquement modifié, Animaux, Anticorps antiviraux (administration et posologie), Anticorps antiviraux (effets indésirables), Bovins, Coronavirus du syndrome respiratoire du Moyen-Orient (immunologie), Effets secondaires indésirables des médicaments (anatomopathologie), Effets secondaires indésirables des médicaments (épidémiologie), Femelle, Humains, Immunisation passive (), Immunisation passive (effets indésirables), Immunoglobuline G (administration et posologie), Immunoglobuline G (effets indésirables), Jeune adulte, Mâle, Méthode en double aveugle, National Institutes of Health (USA), Perfusions veineuses, Placebo (administration et posologie), Volontaires sains, États-Unis d'Amérique, Études de suivi.
- MESH :
- administration et posologie : Anticorps antiviraux, Immunoglobuline G, Placebo.
- anatomopathologie : Effets secondaires indésirables des médicaments.
- effets indésirables : Anticorps antiviraux, Immunisation passive, Immunoglobuline G.
- immunologie : Coronavirus du syndrome respiratoire du Moyen-Orient.
- épidémiologie : Effets secondaires indésirables des médicaments.
- Adulte, Adulte d'âge moyen, Animal génétiquement modifié, Animaux, Bovins, Femelle, Humains, Immunisation passive, Jeune adulte, Mâle, Méthode en double aveugle, National Institutes of Health (USA), Perfusions veineuses, Volontaires sains, États-Unis d'Amérique, Études de suivi.
- Wicri :
- geographic : États-Unis.
English descriptors
- KwdEn :
- Adult, Animals, Animals, Genetically Modified, Antibodies, Viral (administration & dosage), Antibodies, Viral (adverse effects), Cattle, Double-Blind Method, Drug-Related Side Effects and Adverse Reactions (epidemiology), Drug-Related Side Effects and Adverse Reactions (pathology), Female, Follow-Up Studies, Healthy Volunteers, Humans, Immunization, Passive (adverse effects), Immunization, Passive (methods), Immunoglobulin G (administration & dosage), Immunoglobulin G (adverse effects), Infusions, Intravenous, Male, Middle Aged, Middle East Respiratory Syndrome Coronavirus (immunology), National Institutes of Health (U.S.), Placebos (administration & dosage), United States, Young Adult.
- MESH :
- chemical , administration & dosage : Antibodies, Viral, Immunoglobulin G, Placebos.
- chemical , adverse effects : Antibodies, Viral, Immunoglobulin G.
- geographic : United States.
- adverse effects : Immunization, Passive.
- epidemiology : Drug-Related Side Effects and Adverse Reactions.
- immunology : Middle East Respiratory Syndrome Coronavirus.
- methods : Immunization, Passive.
- pathology : Drug-Related Side Effects and Adverse Reactions.
- Adult, Animals, Animals, Genetically Modified, Cattle, Double-Blind Method, Female, Follow-Up Studies, Healthy Volunteers, Humans, Infusions, Intravenous, Male, Middle Aged, National Institutes of Health (U.S.), Young Adult.
Abstract
Middle East respiratory syndrome (MERS) is a severe respiratory illness with an overall mortality of 35%. There is no licensed or proven treatment. Passive immunotherapy approaches are being developed to prevent and treat several human medical conditions where alternative therapeutic options are absent. We report the safety of a fully human polyclonal IgG antibody (SAB-301) produced from the hyperimmune plasma of transchromosomic cattle immunised with a MERS coronavirus vaccine.
DOI: 10.1016/S1473-3099(18)30002-1
PubMed: 29329957
Affiliations:
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Le document en format XML
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Beigel</name><affiliation wicri:level="2"><nlm:affiliation>Leidos Biomedical Research Inc, Frederick, MD, USA. 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Aged</term><term>Middle East Respiratory Syndrome Coronavirus (immunology)</term><term>National Institutes of Health (U.S.)</term><term>Placebos (administration & dosage)</term><term>United States</term><term>Young Adult</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Animal génétiquement modifié</term><term>Animaux</term><term>Anticorps antiviraux (administration et posologie)</term><term>Anticorps antiviraux (effets indésirables)</term><term>Bovins</term><term>Coronavirus du syndrome respiratoire du Moyen-Orient (immunologie)</term><term>Effets secondaires indésirables des médicaments (anatomopathologie)</term><term>Effets secondaires indésirables des médicaments (épidémiologie)</term><term>Femelle</term><term>Humains</term><term>Immunisation passive ()</term><term>Immunisation passive (effets indésirables)</term><term>Immunoglobuline G (administration et posologie)</term><term>Immunoglobuline G (effets indésirables)</term><term>Jeune adulte</term><term>Mâle</term><term>Méthode en double aveugle</term><term>National Institutes of Health (USA)</term><term>Perfusions veineuses</term><term>Placebo (administration et posologie)</term><term>Volontaires sains</term><term>États-Unis d'Amérique</term><term>Études de suivi</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antibodies, Viral</term><term>Immunoglobulin G</term><term>Placebos</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antibodies, Viral</term><term>Immunoglobulin G</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>United States</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Anticorps antiviraux</term><term>Immunoglobuline G</term><term>Placebo</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Immunization, Passive</term></keywords><keywords scheme="MESH" qualifier="anatomopathologie" xml:lang="fr"><term>Effets secondaires indésirables des médicaments</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Anticorps antiviraux</term><term>Immunisation passive</term><term>Immunoglobuline G</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Drug-Related Side Effects and Adverse Reactions</term></keywords><keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Coronavirus du syndrome respiratoire du Moyen-Orient</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Middle East Respiratory Syndrome Coronavirus</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Immunization, Passive</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Drug-Related Side Effects and Adverse Reactions</term></keywords><keywords scheme="MESH" qualifier="épidémiologie" xml:lang="fr"><term>Effets secondaires indésirables des médicaments</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Animals</term><term>Animals, Genetically Modified</term><term>Cattle</term><term>Double-Blind Method</term><term>Female</term><term>Follow-Up Studies</term><term>Healthy Volunteers</term><term>Humans</term><term>Infusions, Intravenous</term><term>Male</term><term>Middle Aged</term><term>National Institutes of Health (U.S.)</term><term>Young Adult</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Animal génétiquement modifié</term><term>Animaux</term><term>Bovins</term><term>Femelle</term><term>Humains</term><term>Immunisation passive</term><term>Jeune adulte</term><term>Mâle</term><term>Méthode en double aveugle</term><term>National Institutes of Health (USA)</term><term>Perfusions veineuses</term><term>Volontaires sains</term><term>États-Unis d'Amérique</term><term>Études de suivi</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>États-Unis</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Middle East respiratory syndrome (MERS) is a severe respiratory illness with an overall mortality of 35%. There is no licensed or proven treatment. Passive immunotherapy approaches are being developed to prevent and treat several human medical conditions where alternative therapeutic options are absent. We report the safety of a fully human polyclonal IgG antibody (SAB-301) produced from the hyperimmune plasma of transchromosomic cattle immunised with a MERS coronavirus vaccine.</div></front></TEI><affiliations><list><country><li>États-Unis</li></country><region><li>Dakota du Sud</li><li>Maryland</li></region></list><tree><country name="États-Unis"><region name="Maryland"><name sortKey="Beigel, John H" sort="Beigel, John H" uniqKey="Beigel J" first="John H" last="Beigel">John H. Beigel</name></region><name sortKey="Davey, Richard T" sort="Davey, Richard T" uniqKey="Davey R" first="Richard T" last="Davey">Richard T. Davey</name><name sortKey="Jiao, Jin An" sort="Jiao, Jin An" uniqKey="Jiao J" first="Jin-An" last="Jiao">Jin-An Jiao</name><name sortKey="Kumar, Parag" sort="Kumar, Parag" uniqKey="Kumar P" first="Parag" last="Kumar">Parag Kumar</name><name sortKey="Luke, Thomas" sort="Luke, Thomas" uniqKey="Luke T" first="Thomas" last="Luke">Thomas Luke</name><name sortKey="Raviprakash, Kanakatte" sort="Raviprakash, Kanakatte" uniqKey="Raviprakash K" first="Kanakatte" last="Raviprakash">Kanakatte Raviprakash</name><name sortKey="Sullivan, Eddie" sort="Sullivan, Eddie" uniqKey="Sullivan E" first="Eddie" last="Sullivan">Eddie Sullivan</name><name sortKey="Voell, Jocelyn" sort="Voell, Jocelyn" uniqKey="Voell J" first="Jocelyn" last="Voell">Jocelyn Voell</name><name sortKey="Wu, Hua" sort="Wu, Hua" uniqKey="Wu H" first="Hua" last="Wu">Hua Wu</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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