Placebo use in vaccine trials: recommendations of a WHO expert panel.
Identifieur interne : 002083 ( PubMed/Curation ); précédent : 002082; suivant : 002084Placebo use in vaccine trials: recommendations of a WHO expert panel.
Auteurs : Annette Rid [Royaume-Uni] ; Abha Saxena [Suisse] ; Abdhullah H. Baqui [États-Unis] ; Anant Bhan [Canada] ; Julie Bines [Australie] ; Marie-Charlotte Bouesseau [Suisse] ; Arthur Caplan [États-Unis] ; James Colgrove [États-Unis] ; Ames Dhai [Afrique du Sud] ; Rita Gomez-Diaz [Mexique] ; Shane K. Green [Canada] ; Gagandeep Kang [Inde] ; Rosanna Lagos [Chili] ; Patricia Loh [Australie] ; Alex John London [États-Unis] ; Kim Mulholland [Royaume-Uni] ; Pieter Neels [Belgique] ; Punee Pitisuttithum [Thaïlande] ; Samba Cor Sarr [Sénégal] ; Michael Selgelid [Australie] ; Mark Sheehan [Royaume-Uni] ; Peter G. Smith [Royaume-Uni]Source :
- Vaccine [ 1873-2518 ] ; 2014.
Descripteurs français
- KwdFr :
- MESH :
English descriptors
- KwdEn :
- MESH :
- chemical : Placebos, Vaccines.
- ethics : Randomized Controlled Trials as Topic.
- Guidelines as Topic, Research Design, World Health Organization.
Abstract
Vaccines are among the most cost-effective interventions against infectious diseases. Many candidate vaccines targeting neglected diseases in low- and middle-income countries are now progressing to large-scale clinical testing. However, controversy surrounds the appropriate design of vaccine trials and, in particular, the use of unvaccinated controls (with or without placebo) when an efficacious vaccine already exists. This paper specifies four situations in which placebo use may be acceptable, provided that the study question cannot be answered in an active-controlled trial design; the risks of delaying or foregoing an efficacious vaccine are mitigated; the risks of using a placebo control are justified by the social and public health value of the research; and the research is responsive to local health needs. The four situations are: (1) developing a locally affordable vaccine, (2) evaluating the local safety and efficacy of an existing vaccine, (3) testing a new vaccine when an existing vaccine is considered inappropriate for local use (e.g. based on epidemiologic or demographic factors), and (4) determining the local burden of disease.
DOI: 10.1016/j.vaccine.2014.04.022
PubMed: 24768580
Links toward previous steps (curation, corpus...)
- to stream PubMed, to step Corpus: Pour aller vers cette notice dans l'étape Curation :002092
Links to Exploration step
pubmed:24768580Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Placebo use in vaccine trials: recommendations of a WHO expert panel.</title><author><name sortKey="Rid, Annette" sort="Rid, Annette" uniqKey="Rid A" first="Annette" last="Rid">Annette Rid</name><affiliation wicri:level="1"><nlm:affiliation>Department of Social Science, Health & Medicine, King's College London, Strand, London WC2R 2LS, United Kingdom. Electronic address: annette.rid@kcl.ac.uk.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Social Science, Health & Medicine, King's College London, Strand, London WC2R 2LS</wicri:regionArea></affiliation></author><author><name sortKey="Saxena, Abha" sort="Saxena, Abha" uniqKey="Saxena A" first="Abha" last="Saxena">Abha Saxena</name><affiliation wicri:level="1"><nlm:affiliation>Knowledge, Ethics and Research, World Health Organization, Geneva, Switzerland.</nlm:affiliation><country xml:lang="fr">Suisse</country><wicri:regionArea>Knowledge, Ethics and Research, World Health Organization, Geneva</wicri:regionArea></affiliation></author><author><name sortKey="Baqui, Abdhullah H" sort="Baqui, Abdhullah H" uniqKey="Baqui A" first="Abdhullah H" last="Baqui">Abdhullah H. Baqui</name><affiliation wicri:level="1"><nlm:affiliation>International Center for Maternal and Newborn Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>International Center for Maternal and Newborn Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD</wicri:regionArea></affiliation></author><author><name sortKey="Bhan, Anant" sort="Bhan, Anant" uniqKey="Bhan A" first="Anant" last="Bhan">Anant Bhan</name><affiliation wicri:level="1"><nlm:affiliation>Ethical, Social and Cultural Program for Global Health, University of Toronto, Toronto, ON, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Ethical, Social and Cultural Program for Global Health, University of Toronto, Toronto, ON</wicri:regionArea></affiliation></author><author><name sortKey="Bines, Julie" sort="Bines, Julie" uniqKey="Bines J" first="Julie" last="Bines">Julie Bines</name><affiliation wicri:level="1"><nlm:affiliation>Murdoch Childrens Research Institute, University of Melbourne, Parkville, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Murdoch Childrens Research Institute, University of Melbourne, Parkville, VIC</wicri:regionArea></affiliation></author><author><name sortKey="Bouesseau, Marie Charlotte" sort="Bouesseau, Marie Charlotte" uniqKey="Bouesseau M" first="Marie-Charlotte" last="Bouesseau">Marie-Charlotte Bouesseau</name><affiliation wicri:level="1"><nlm:affiliation>Service Delivery and Safety, World Health Organization, Geneva, Switzerland.</nlm:affiliation><country xml:lang="fr">Suisse</country><wicri:regionArea>Service Delivery and Safety, World Health Organization, Geneva</wicri:regionArea></affiliation></author><author><name sortKey="Caplan, Arthur" sort="Caplan, Arthur" uniqKey="Caplan A" first="Arthur" last="Caplan">Arthur Caplan</name><affiliation wicri:level="1"><nlm:affiliation>Division of Medical Ethics, NYU School of Medicine, New York, NY, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Division of Medical Ethics, NYU School of Medicine, New York, NY</wicri:regionArea></affiliation></author><author><name sortKey="Colgrove, James" sort="Colgrove, James" uniqKey="Colgrove J" first="James" last="Colgrove">James Colgrove</name><affiliation wicri:level="1"><nlm:affiliation>Mailman School of Public Health, Columbia University, New York, NY, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Mailman School of Public Health, Columbia University, New York, NY</wicri:regionArea></affiliation></author><author><name sortKey="Dhai, Ames" sort="Dhai, Ames" uniqKey="Dhai A" first="Ames" last="Dhai">Ames Dhai</name><affiliation wicri:level="1"><nlm:affiliation>Steve Biko Centre for Bioethics, University of Witwatersrand, Johannesburg, South Africa.</nlm:affiliation><country xml:lang="fr">Afrique du Sud</country><wicri:regionArea>Steve Biko Centre for Bioethics, University of Witwatersrand, Johannesburg</wicri:regionArea></affiliation></author><author><name sortKey="Gomez Diaz, Rita" sort="Gomez Diaz, Rita" uniqKey="Gomez Diaz R" first="Rita" last="Gomez-Diaz">Rita Gomez-Diaz</name><affiliation wicri:level="1"><nlm:affiliation>Instituto Mexicano del Seguro Social, Centro Médico Nacional Siglo XXI, Ciudad de Mexico, D.F., Mexico.</nlm:affiliation><country xml:lang="fr">Mexique</country><wicri:regionArea>Instituto Mexicano del Seguro Social, Centro Médico Nacional Siglo XXI, Ciudad de Mexico, D.F.</wicri:regionArea></affiliation></author><author><name sortKey="Green, Shane K" sort="Green, Shane K" uniqKey="Green S" first="Shane K" last="Green">Shane K. Green</name><affiliation wicri:level="1"><nlm:affiliation>Ethical, Social and Cultural Program for Global Health, St. Michael's Hospital and University of Toronto, Toronto, ON, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Ethical, Social and Cultural Program for Global Health, St. Michael's Hospital and University of Toronto, Toronto, ON</wicri:regionArea></affiliation></author><author><name sortKey="Kang, Gagandeep" sort="Kang, Gagandeep" uniqKey="Kang G" first="Gagandeep" last="Kang">Gagandeep Kang</name><affiliation wicri:level="1"><nlm:affiliation>Christian Medical College, Vellore, Tamil Nadu, India.</nlm:affiliation><country xml:lang="fr">Inde</country><wicri:regionArea>Christian Medical College, Vellore, Tamil Nadu</wicri:regionArea></affiliation></author><author><name sortKey="Lagos, Rosanna" sort="Lagos, Rosanna" uniqKey="Lagos R" first="Rosanna" last="Lagos">Rosanna Lagos</name><affiliation wicri:level="1"><nlm:affiliation>Hospital de Niños Roberto del Río, Santiago de Chile, Chile.</nlm:affiliation><country xml:lang="fr">Chili</country><wicri:regionArea>Hospital de Niños Roberto del Río, Santiago de Chile</wicri:regionArea></affiliation></author><author><name sortKey="Loh, Patricia" sort="Loh, Patricia" uniqKey="Loh P" first="Patricia" last="Loh">Patricia Loh</name><affiliation wicri:level="1"><nlm:affiliation>Melbourne Law School, University of Melbourne, Carlton, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Melbourne Law School, University of Melbourne, Carlton, VIC</wicri:regionArea></affiliation></author><author><name sortKey="London, Alex John" sort="London, Alex John" uniqKey="London A" first="Alex John" last="London">Alex John London</name><affiliation wicri:level="1"><nlm:affiliation>Department of Philosophy, Carnegie Mellon University, Pittsburgh, PA, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Philosophy, Carnegie Mellon University, Pittsburgh, PA</wicri:regionArea></affiliation></author><author><name sortKey="Mulholland, Kim" sort="Mulholland, Kim" uniqKey="Mulholland K" first="Kim" last="Mulholland">Kim Mulholland</name><affiliation wicri:level="1"><nlm:affiliation>London School of Hygiene and Tropical Medicine, London, United Kingdom.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>London School of Hygiene and Tropical Medicine, London</wicri:regionArea></affiliation></author><author><name sortKey="Neels, Pieter" sort="Neels, Pieter" uniqKey="Neels P" first="Pieter" last="Neels">Pieter Neels</name><affiliation wicri:level="1"><nlm:affiliation>Vaccine Advice BVBA, Zoersel, Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>Vaccine Advice BVBA, Zoersel</wicri:regionArea></affiliation></author><author><name sortKey="Pitisuttithum, Punee" sort="Pitisuttithum, Punee" uniqKey="Pitisuttithum P" first="Punee" last="Pitisuttithum">Punee Pitisuttithum</name><affiliation wicri:level="1"><nlm:affiliation>Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.</nlm:affiliation><country xml:lang="fr">Thaïlande</country><wicri:regionArea>Faculty of Tropical Medicine, Mahidol University, Bangkok</wicri:regionArea></affiliation></author><author><name sortKey="Sarr, Samba Cor" sort="Sarr, Samba Cor" uniqKey="Sarr S" first="Samba Cor" last="Sarr">Samba Cor Sarr</name><affiliation wicri:level="1"><nlm:affiliation>Ministry of Health and Social Action 1, Dakar-Fann, Senegal.</nlm:affiliation><country xml:lang="fr">Sénégal</country><wicri:regionArea>Ministry of Health and Social Action 1, Dakar-Fann</wicri:regionArea></affiliation></author><author><name sortKey="Selgelid, Michael" sort="Selgelid, Michael" uniqKey="Selgelid M" first="Michael" last="Selgelid">Michael Selgelid</name><affiliation wicri:level="1"><nlm:affiliation>Centre for Human Bioethics, Monash University, Monash, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Centre for Human Bioethics, Monash University, Monash, VIC</wicri:regionArea></affiliation></author><author><name sortKey="Sheehan, Mark" sort="Sheehan, Mark" uniqKey="Sheehan M" first="Mark" last="Sheehan">Mark Sheehan</name><affiliation wicri:level="1"><nlm:affiliation>The Ethox Centre, University of Oxford, Oxford, United Kingdom.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>The Ethox Centre, University of Oxford, Oxford</wicri:regionArea></affiliation></author><author><name sortKey="Smith, Peter G" sort="Smith, Peter G" uniqKey="Smith P" first="Peter G" last="Smith">Peter G. Smith</name><affiliation wicri:level="1"><nlm:affiliation>Medical Research Council (MRC) Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, United Kingdom.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Medical Research Council (MRC) Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2014">2014</date><idno type="RBID">pubmed:24768580</idno><idno type="pmid">24768580</idno><idno type="doi">10.1016/j.vaccine.2014.04.022</idno><idno type="wicri:Area/PubMed/Corpus">002092</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">002092</idno><idno type="wicri:Area/PubMed/Curation">002083</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">002083</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Placebo use in vaccine trials: recommendations of a WHO expert panel.</title><author><name sortKey="Rid, Annette" sort="Rid, Annette" uniqKey="Rid A" first="Annette" last="Rid">Annette Rid</name><affiliation wicri:level="1"><nlm:affiliation>Department of Social Science, Health & Medicine, King's College London, Strand, London WC2R 2LS, United Kingdom. Electronic address: annette.rid@kcl.ac.uk.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Social Science, Health & Medicine, King's College London, Strand, London WC2R 2LS</wicri:regionArea></affiliation></author><author><name sortKey="Saxena, Abha" sort="Saxena, Abha" uniqKey="Saxena A" first="Abha" last="Saxena">Abha Saxena</name><affiliation wicri:level="1"><nlm:affiliation>Knowledge, Ethics and Research, World Health Organization, Geneva, Switzerland.</nlm:affiliation><country xml:lang="fr">Suisse</country><wicri:regionArea>Knowledge, Ethics and Research, World Health Organization, Geneva</wicri:regionArea></affiliation></author><author><name sortKey="Baqui, Abdhullah H" sort="Baqui, Abdhullah H" uniqKey="Baqui A" first="Abdhullah H" last="Baqui">Abdhullah H. Baqui</name><affiliation wicri:level="1"><nlm:affiliation>International Center for Maternal and Newborn Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>International Center for Maternal and Newborn Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD</wicri:regionArea></affiliation></author><author><name sortKey="Bhan, Anant" sort="Bhan, Anant" uniqKey="Bhan A" first="Anant" last="Bhan">Anant Bhan</name><affiliation wicri:level="1"><nlm:affiliation>Ethical, Social and Cultural Program for Global Health, University of Toronto, Toronto, ON, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Ethical, Social and Cultural Program for Global Health, University of Toronto, Toronto, ON</wicri:regionArea></affiliation></author><author><name sortKey="Bines, Julie" sort="Bines, Julie" uniqKey="Bines J" first="Julie" last="Bines">Julie Bines</name><affiliation wicri:level="1"><nlm:affiliation>Murdoch Childrens Research Institute, University of Melbourne, Parkville, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Murdoch Childrens Research Institute, University of Melbourne, Parkville, VIC</wicri:regionArea></affiliation></author><author><name sortKey="Bouesseau, Marie Charlotte" sort="Bouesseau, Marie Charlotte" uniqKey="Bouesseau M" first="Marie-Charlotte" last="Bouesseau">Marie-Charlotte Bouesseau</name><affiliation wicri:level="1"><nlm:affiliation>Service Delivery and Safety, World Health Organization, Geneva, Switzerland.</nlm:affiliation><country xml:lang="fr">Suisse</country><wicri:regionArea>Service Delivery and Safety, World Health Organization, Geneva</wicri:regionArea></affiliation></author><author><name sortKey="Caplan, Arthur" sort="Caplan, Arthur" uniqKey="Caplan A" first="Arthur" last="Caplan">Arthur Caplan</name><affiliation wicri:level="1"><nlm:affiliation>Division of Medical Ethics, NYU School of Medicine, New York, NY, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Division of Medical Ethics, NYU School of Medicine, New York, NY</wicri:regionArea></affiliation></author><author><name sortKey="Colgrove, James" sort="Colgrove, James" uniqKey="Colgrove J" first="James" last="Colgrove">James Colgrove</name><affiliation wicri:level="1"><nlm:affiliation>Mailman School of Public Health, Columbia University, New York, NY, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Mailman School of Public Health, Columbia University, New York, NY</wicri:regionArea></affiliation></author><author><name sortKey="Dhai, Ames" sort="Dhai, Ames" uniqKey="Dhai A" first="Ames" last="Dhai">Ames Dhai</name><affiliation wicri:level="1"><nlm:affiliation>Steve Biko Centre for Bioethics, University of Witwatersrand, Johannesburg, South Africa.</nlm:affiliation><country xml:lang="fr">Afrique du Sud</country><wicri:regionArea>Steve Biko Centre for Bioethics, University of Witwatersrand, Johannesburg</wicri:regionArea></affiliation></author><author><name sortKey="Gomez Diaz, Rita" sort="Gomez Diaz, Rita" uniqKey="Gomez Diaz R" first="Rita" last="Gomez-Diaz">Rita Gomez-Diaz</name><affiliation wicri:level="1"><nlm:affiliation>Instituto Mexicano del Seguro Social, Centro Médico Nacional Siglo XXI, Ciudad de Mexico, D.F., Mexico.</nlm:affiliation><country xml:lang="fr">Mexique</country><wicri:regionArea>Instituto Mexicano del Seguro Social, Centro Médico Nacional Siglo XXI, Ciudad de Mexico, D.F.</wicri:regionArea></affiliation></author><author><name sortKey="Green, Shane K" sort="Green, Shane K" uniqKey="Green S" first="Shane K" last="Green">Shane K. Green</name><affiliation wicri:level="1"><nlm:affiliation>Ethical, Social and Cultural Program for Global Health, St. Michael's Hospital and University of Toronto, Toronto, ON, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Ethical, Social and Cultural Program for Global Health, St. Michael's Hospital and University of Toronto, Toronto, ON</wicri:regionArea></affiliation></author><author><name sortKey="Kang, Gagandeep" sort="Kang, Gagandeep" uniqKey="Kang G" first="Gagandeep" last="Kang">Gagandeep Kang</name><affiliation wicri:level="1"><nlm:affiliation>Christian Medical College, Vellore, Tamil Nadu, India.</nlm:affiliation><country xml:lang="fr">Inde</country><wicri:regionArea>Christian Medical College, Vellore, Tamil Nadu</wicri:regionArea></affiliation></author><author><name sortKey="Lagos, Rosanna" sort="Lagos, Rosanna" uniqKey="Lagos R" first="Rosanna" last="Lagos">Rosanna Lagos</name><affiliation wicri:level="1"><nlm:affiliation>Hospital de Niños Roberto del Río, Santiago de Chile, Chile.</nlm:affiliation><country xml:lang="fr">Chili</country><wicri:regionArea>Hospital de Niños Roberto del Río, Santiago de Chile</wicri:regionArea></affiliation></author><author><name sortKey="Loh, Patricia" sort="Loh, Patricia" uniqKey="Loh P" first="Patricia" last="Loh">Patricia Loh</name><affiliation wicri:level="1"><nlm:affiliation>Melbourne Law School, University of Melbourne, Carlton, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Melbourne Law School, University of Melbourne, Carlton, VIC</wicri:regionArea></affiliation></author><author><name sortKey="London, Alex John" sort="London, Alex John" uniqKey="London A" first="Alex John" last="London">Alex John London</name><affiliation wicri:level="1"><nlm:affiliation>Department of Philosophy, Carnegie Mellon University, Pittsburgh, PA, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Philosophy, Carnegie Mellon University, Pittsburgh, PA</wicri:regionArea></affiliation></author><author><name sortKey="Mulholland, Kim" sort="Mulholland, Kim" uniqKey="Mulholland K" first="Kim" last="Mulholland">Kim Mulholland</name><affiliation wicri:level="1"><nlm:affiliation>London School of Hygiene and Tropical Medicine, London, United Kingdom.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>London School of Hygiene and Tropical Medicine, London</wicri:regionArea></affiliation></author><author><name sortKey="Neels, Pieter" sort="Neels, Pieter" uniqKey="Neels P" first="Pieter" last="Neels">Pieter Neels</name><affiliation wicri:level="1"><nlm:affiliation>Vaccine Advice BVBA, Zoersel, Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>Vaccine Advice BVBA, Zoersel</wicri:regionArea></affiliation></author><author><name sortKey="Pitisuttithum, Punee" sort="Pitisuttithum, Punee" uniqKey="Pitisuttithum P" first="Punee" last="Pitisuttithum">Punee Pitisuttithum</name><affiliation wicri:level="1"><nlm:affiliation>Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.</nlm:affiliation><country xml:lang="fr">Thaïlande</country><wicri:regionArea>Faculty of Tropical Medicine, Mahidol University, Bangkok</wicri:regionArea></affiliation></author><author><name sortKey="Sarr, Samba Cor" sort="Sarr, Samba Cor" uniqKey="Sarr S" first="Samba Cor" last="Sarr">Samba Cor Sarr</name><affiliation wicri:level="1"><nlm:affiliation>Ministry of Health and Social Action 1, Dakar-Fann, Senegal.</nlm:affiliation><country xml:lang="fr">Sénégal</country><wicri:regionArea>Ministry of Health and Social Action 1, Dakar-Fann</wicri:regionArea></affiliation></author><author><name sortKey="Selgelid, Michael" sort="Selgelid, Michael" uniqKey="Selgelid M" first="Michael" last="Selgelid">Michael Selgelid</name><affiliation wicri:level="1"><nlm:affiliation>Centre for Human Bioethics, Monash University, Monash, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Centre for Human Bioethics, Monash University, Monash, VIC</wicri:regionArea></affiliation></author><author><name sortKey="Sheehan, Mark" sort="Sheehan, Mark" uniqKey="Sheehan M" first="Mark" last="Sheehan">Mark Sheehan</name><affiliation wicri:level="1"><nlm:affiliation>The Ethox Centre, University of Oxford, Oxford, United Kingdom.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>The Ethox Centre, University of Oxford, Oxford</wicri:regionArea></affiliation></author><author><name sortKey="Smith, Peter G" sort="Smith, Peter G" uniqKey="Smith P" first="Peter G" last="Smith">Peter G. Smith</name><affiliation wicri:level="1"><nlm:affiliation>Medical Research Council (MRC) Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, United Kingdom.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Medical Research Council (MRC) Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London</wicri:regionArea></affiliation></author></analytic><series><title level="j">Vaccine</title><idno type="eISSN">1873-2518</idno><imprint><date when="2014" type="published">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Guidelines as Topic</term><term>Placebos</term><term>Randomized Controlled Trials as Topic (ethics)</term><term>Research Design</term><term>Vaccines</term><term>World Health Organization</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Essais contrôlés randomisés comme sujet (éthique)</term><term>Organisation mondiale de la santé</term><term>Placebo</term><term>Plan de recherche</term><term>Recommandations comme sujet</term><term>Vaccins</term></keywords><keywords scheme="MESH" type="chemical" xml:lang="en"><term>Placebos</term><term>Vaccines</term></keywords><keywords scheme="MESH" qualifier="ethics" xml:lang="en"><term>Randomized Controlled Trials as Topic</term></keywords><keywords scheme="MESH" qualifier="éthique" xml:lang="fr"><term>Essais contrôlés randomisés comme sujet</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Guidelines as Topic</term><term>Research Design</term><term>World Health Organization</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Organisation mondiale de la santé</term><term>Placebo</term><term>Plan de recherche</term><term>Recommandations comme sujet</term><term>Vaccins</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Vaccines are among the most cost-effective interventions against infectious diseases. Many candidate vaccines targeting neglected diseases in low- and middle-income countries are now progressing to large-scale clinical testing. However, controversy surrounds the appropriate design of vaccine trials and, in particular, the use of unvaccinated controls (with or without placebo) when an efficacious vaccine already exists. This paper specifies four situations in which placebo use may be acceptable, provided that the study question cannot be answered in an active-controlled trial design; the risks of delaying or foregoing an efficacious vaccine are mitigated; the risks of using a placebo control are justified by the social and public health value of the research; and the research is responsive to local health needs. The four situations are: (1) developing a locally affordable vaccine, (2) evaluating the local safety and efficacy of an existing vaccine, (3) testing a new vaccine when an existing vaccine is considered inappropriate for local use (e.g. based on epidemiologic or demographic factors), and (4) determining the local burden of disease.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">24768580</PMID><DateCreated><Year>2014</Year><Month>08</Month><Day>04</Day></DateCreated><DateCompleted><Year>2015</Year><Month>03</Month><Day>09</Day></DateCompleted><DateRevised><Year>2017</Year><Month>09</Month><Day>22</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1873-2518</ISSN><JournalIssue CitedMedium="Internet"><Volume>32</Volume><Issue>37</Issue><PubDate><Year>2014</Year><Month>Aug</Month><Day>20</Day></PubDate></JournalIssue><Title>Vaccine</Title><ISOAbbreviation>Vaccine</ISOAbbreviation></Journal><ArticleTitle>Placebo use in vaccine trials: recommendations of a WHO expert panel.</ArticleTitle><Pagination><MedlinePgn>4708-12</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.vaccine.2014.04.022</ELocationID><ELocationID EIdType="pii" ValidYN="Y">S0264-410X(14)00537-4</ELocationID><Abstract><AbstractText>Vaccines are among the most cost-effective interventions against infectious diseases. Many candidate vaccines targeting neglected diseases in low- and middle-income countries are now progressing to large-scale clinical testing. However, controversy surrounds the appropriate design of vaccine trials and, in particular, the use of unvaccinated controls (with or without placebo) when an efficacious vaccine already exists. This paper specifies four situations in which placebo use may be acceptable, provided that the study question cannot be answered in an active-controlled trial design; the risks of delaying or foregoing an efficacious vaccine are mitigated; the risks of using a placebo control are justified by the social and public health value of the research; and the research is responsive to local health needs. The four situations are: (1) developing a locally affordable vaccine, (2) evaluating the local safety and efficacy of an existing vaccine, (3) testing a new vaccine when an existing vaccine is considered inappropriate for local use (e.g. based on epidemiologic or demographic factors), and (4) determining the local burden of disease.</AbstractText><CopyrightInformation>Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Rid</LastName><ForeName>Annette</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Social Science, Health & Medicine, King's College London, Strand, London WC2R 2LS, United Kingdom. Electronic address: annette.rid@kcl.ac.uk.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Saxena</LastName><ForeName>Abha</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Knowledge, Ethics and Research, World Health Organization, Geneva, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Baqui</LastName><ForeName>Abdhullah H</ForeName><Initials>AH</Initials><AffiliationInfo><Affiliation>International Center for Maternal and Newborn Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bhan</LastName><ForeName>Anant</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Ethical, Social and Cultural Program for Global Health, University of Toronto, Toronto, ON, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bines</LastName><ForeName>Julie</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Murdoch Childrens Research Institute, University of Melbourne, Parkville, VIC, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bouesseau</LastName><ForeName>Marie-Charlotte</ForeName><Initials>MC</Initials><AffiliationInfo><Affiliation>Service Delivery and Safety, World Health Organization, Geneva, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Caplan</LastName><ForeName>Arthur</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Division of Medical Ethics, NYU School of Medicine, New York, NY, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Colgrove</LastName><ForeName>James</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Mailman School of Public Health, Columbia University, New York, NY, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dhai</LastName><ForeName>Ames</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Steve Biko Centre for Bioethics, University of Witwatersrand, Johannesburg, South Africa.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gomez-Diaz</LastName><ForeName>Rita</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Instituto Mexicano del Seguro Social, Centro Médico Nacional Siglo XXI, Ciudad de Mexico, D.F., Mexico.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Green</LastName><ForeName>Shane K</ForeName><Initials>SK</Initials><AffiliationInfo><Affiliation>Ethical, Social and Cultural Program for Global Health, St. Michael's Hospital and University of Toronto, Toronto, ON, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kang</LastName><ForeName>Gagandeep</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Christian Medical College, Vellore, Tamil Nadu, India.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lagos</LastName><ForeName>Rosanna</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Hospital de Niños Roberto del Río, Santiago de Chile, Chile.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Loh</LastName><ForeName>Patricia</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Melbourne Law School, University of Melbourne, Carlton, VIC, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>London</LastName><ForeName>Alex John</ForeName><Initials>AJ</Initials><AffiliationInfo><Affiliation>Department of Philosophy, Carnegie Mellon University, Pittsburgh, PA, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mulholland</LastName><ForeName>Kim</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>London School of Hygiene and Tropical Medicine, London, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Neels</LastName><ForeName>Pieter</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Vaccine Advice BVBA, Zoersel, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pitisuttithum</LastName><ForeName>Punee</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sarr</LastName><ForeName>Samba Cor</ForeName><Initials>SC</Initials><AffiliationInfo><Affiliation>Ministry of Health and Social Action 1, Dakar-Fann, Senegal.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Selgelid</LastName><ForeName>Michael</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Centre for Human Bioethics, Monash University, Monash, VIC, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sheehan</LastName><ForeName>Mark</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>The Ethox Centre, University of Oxford, Oxford, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Smith</LastName><ForeName>Peter G</ForeName><Initials>PG</Initials><AffiliationInfo><Affiliation>Medical Research Council (MRC) Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, United Kingdom.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><GrantList CompleteYN="Y"><Grant><GrantID>001</GrantID><Agency>World Health Organization</Agency><Country>International</Country></Grant><Grant><GrantID>MR/K012126/1</GrantID><Agency>Medical Research Council</Agency><Country>United Kingdom</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2014</Year><Month>04</Month><Day>25</Day></ArticleDate></Article><MedlineJournalInfo><Country>Netherlands</Country><MedlineTA>Vaccine</MedlineTA><NlmUniqueID>8406899</NlmUniqueID><ISSNLinking>0264-410X</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D010919">Placebos</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D014612">Vaccines</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Bull Med Ethics. 2002 Oct;(182):17-23</RefSource><PMID Version="1">14983848</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Indian J Lepr. 1998 Oct-Dec;70(4):369-88</RefSource><PMID Version="1">10189587</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Lancet. 2005 Jan 1-7;365(9453):43-52</RefSource><PMID Version="1">15643700</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Lancet. 2005 Mar 26-Apr 1;365(9465):1139-46</RefSource><PMID Version="1">15794968</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Fed Regist. 2008 Apr 28;73(82):22800-16</RefSource><PMID Version="1">18567164</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Lancet. 2014 Jun 21;383(9935):2136-43</RefSource><PMID Version="1">24629994</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Mem Inst Oswaldo Cruz. 2011 Dec;106(8):907-11</RefSource><PMID Version="1">22241109</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Clin Microbiol Infect. 2012 Oct;18 Suppl 5:57-63</RefSource><PMID Version="1">22882248</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>N Engl J Med. 2012 Dec 13;367(24):2284-95</RefSource><PMID Version="1">23136909</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Lancet. 2012 Dec 15;380(9859):2197-223</RefSource><PMID Version="1">23245608</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>BMC Med Ethics. 2013;14:48</RefSource><PMID Version="1">24289542</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Lancet Infect Dis. 2011 Feb;11(2):102-9</RefSource><PMID Version="1">21237715</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D017408" MajorTopicYN="N">Guidelines as Topic</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D010919" MajorTopicYN="Y">Placebos</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016032" MajorTopicYN="N">Randomized Controlled Trials as Topic</DescriptorName><QualifierName UI="Q000941" MajorTopicYN="Y">ethics</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012107" MajorTopicYN="Y">Research Design</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D014612" MajorTopicYN="Y">Vaccines</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D014944" MajorTopicYN="N">World Health Organization</DescriptorName></MeshHeading></MeshHeadingList><OtherID Source="NLM">PMC4157320</OtherID><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Ethics</Keyword><Keyword MajorTopicYN="N">International research</Keyword><Keyword MajorTopicYN="N">Placebo controls</Keyword><Keyword MajorTopicYN="N">Risk</Keyword><Keyword MajorTopicYN="N">Trial design</Keyword><Keyword MajorTopicYN="N">Vaccine trials</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2014</Year><Month>03</Month><Day>27</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2014</Year><Month>04</Month><Day>02</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2014</Year><Month>4</Month><Day>29</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2014</Year><Month>4</Month><Day>29</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2015</Year><Month>3</Month><Day>10</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">24768580</ArticleId><ArticleId IdType="pii">S0264-410X(14)00537-4</ArticleId><ArticleId IdType="doi">10.1016/j.vaccine.2014.04.022</ArticleId><ArticleId IdType="pmc">PMC4157320</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Amérique/explor/PittsburghV1/Data/PubMed/Curation
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 002083 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/PubMed/Curation/biblio.hfd -nk 002083 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Amérique
|area= PittsburghV1
|flux= PubMed
|étape= Curation
|type= RBID
|clé= pubmed:24768580
|texte= Placebo use in vaccine trials: recommendations of a WHO expert panel.
}}
Pour générer des pages wiki
HfdIndexSelect -h $EXPLOR_AREA/Data/PubMed/Curation/RBID.i -Sk "pubmed:24768580" \
| HfdSelect -Kh $EXPLOR_AREA/Data/PubMed/Curation/biblio.hfd \
| NlmPubMed2Wicri -a PittsburghV1
| This area was generated with Dilib version V0.6.38. |  |