Placebo use in vaccine trials: recommendations of a WHO expert panel.
Identifieur interne : 001B09 ( Main/Exploration ); précédent : 001B08; suivant : 001B10Placebo 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
Affiliations:
- Afrique du Sud, Australie, Belgique, Canada, Chili, Inde, Mexique, Royaume-Uni, Suisse, Sénégal, Thaïlande, États-Unis
- Angleterre, Grand Londres, Maryland, Ontario, Oxfordshire, Pennsylvanie, État de New York
- Londres, New York, Oxford, Pittsburgh, Toronto
- Université Carnegie-Mellon, Université Columbia, Université d'Oxford, Université de Toronto
Links toward previous steps (curation, corpus...)
- to stream PubMed, to step Corpus: 002092
- to stream PubMed, to step Curation: 002083
- to stream PubMed, to step Checkpoint: 002083
- to stream Ncbi, to step Merge: 001D09
- to stream Ncbi, to step Curation: 001D09
- to stream Ncbi, to step Checkpoint: 001D09
- to stream Main, to step Merge: 001B79
- to stream Main, to step Curation: 001B09
Le 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><wicri:noRegion>London WC2R 2LS</wicri:noRegion></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><wicri:noRegion>Geneva</wicri:noRegion></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="2"><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><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Bhan, Anant" sort="Bhan, Anant" uniqKey="Bhan A" first="Anant" last="Bhan">Anant Bhan</name><affiliation wicri:level="4"><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><orgName type="university">Université de Toronto</orgName><placeName><settlement type="city">Toronto</settlement><region type="state">Ontario</region></placeName></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><wicri:noRegion>VIC</wicri:noRegion></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><wicri:noRegion>Geneva</wicri:noRegion></affiliation></author><author><name sortKey="Caplan, Arthur" sort="Caplan, Arthur" uniqKey="Caplan A" first="Arthur" last="Caplan">Arthur Caplan</name><affiliation wicri:level="2"><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><placeName><region type="state">État de New York</region></placeName></affiliation></author><author><name sortKey="Colgrove, James" sort="Colgrove, James" uniqKey="Colgrove J" first="James" last="Colgrove">James Colgrove</name><affiliation wicri:level="4"><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><placeName><region type="state">État de New York</region><settlement type="city">New York</settlement></placeName><orgName type="university">Université Columbia</orgName></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><wicri:noRegion>Johannesburg</wicri:noRegion></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><wicri:noRegion>D.F.</wicri:noRegion></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="4"><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><orgName type="university">Université de Toronto</orgName><placeName><settlement type="city">Toronto</settlement><region type="state">Ontario</region></placeName></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><wicri:noRegion>Tamil Nadu</wicri:noRegion></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><wicri:noRegion>Santiago de Chile</wicri:noRegion></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><wicri:noRegion>VIC</wicri:noRegion></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="4"><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><placeName><region type="state">Pennsylvanie</region><settlement type="city">Pittsburgh</settlement></placeName><orgName type="university">Université Carnegie-Mellon</orgName></affiliation></author><author><name sortKey="Mulholland, Kim" sort="Mulholland, Kim" uniqKey="Mulholland K" first="Kim" last="Mulholland">Kim Mulholland</name><affiliation wicri:level="3"><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><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></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><wicri:noRegion>Zoersel</wicri:noRegion></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><wicri:noRegion>Bangkok</wicri:noRegion></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><wicri:noRegion>Dakar-Fann</wicri:noRegion></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><wicri:noRegion>VIC</wicri:noRegion></affiliation></author><author><name sortKey="Sheehan, Mark" sort="Sheehan, Mark" uniqKey="Sheehan M" first="Mark" last="Sheehan">Mark Sheehan</name><affiliation wicri:level="4"><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><placeName><settlement type="city">Oxford</settlement><region type="country">Angleterre</region><region type="comté" nuts="2">Oxfordshire</region><settlement type="city">Oxford</settlement></placeName><orgName type="university">Université d'Oxford</orgName></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="3"><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><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></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><idno type="wicri:Area/PubMed/Checkpoint">002083</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">002083</idno><idno type="wicri:Area/Ncbi/Merge">001D09</idno><idno type="wicri:Area/Ncbi/Curation">001D09</idno><idno type="wicri:Area/Ncbi/Checkpoint">001D09</idno><idno type="wicri:Area/Main/Merge">001B79</idno><idno type="wicri:Area/Main/Curation">001B09</idno><idno type="wicri:Area/Main/Exploration">001B09</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><wicri:noRegion>London WC2R 2LS</wicri:noRegion></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><wicri:noRegion>Geneva</wicri:noRegion></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="2"><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><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Bhan, Anant" sort="Bhan, Anant" uniqKey="Bhan A" first="Anant" last="Bhan">Anant Bhan</name><affiliation wicri:level="4"><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><orgName type="university">Université de Toronto</orgName><placeName><settlement type="city">Toronto</settlement><region type="state">Ontario</region></placeName></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><wicri:noRegion>VIC</wicri:noRegion></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><wicri:noRegion>Geneva</wicri:noRegion></affiliation></author><author><name sortKey="Caplan, Arthur" sort="Caplan, Arthur" uniqKey="Caplan A" first="Arthur" last="Caplan">Arthur Caplan</name><affiliation wicri:level="2"><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><placeName><region type="state">État de New York</region></placeName></affiliation></author><author><name sortKey="Colgrove, James" sort="Colgrove, James" uniqKey="Colgrove J" first="James" last="Colgrove">James Colgrove</name><affiliation wicri:level="4"><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><placeName><region type="state">État de New York</region><settlement type="city">New York</settlement></placeName><orgName type="university">Université Columbia</orgName></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><wicri:noRegion>Johannesburg</wicri:noRegion></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><wicri:noRegion>D.F.</wicri:noRegion></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="4"><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><orgName type="university">Université de Toronto</orgName><placeName><settlement type="city">Toronto</settlement><region type="state">Ontario</region></placeName></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><wicri:noRegion>Tamil Nadu</wicri:noRegion></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><wicri:noRegion>Santiago de Chile</wicri:noRegion></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><wicri:noRegion>VIC</wicri:noRegion></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="4"><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><placeName><region type="state">Pennsylvanie</region><settlement type="city">Pittsburgh</settlement></placeName><orgName type="university">Université Carnegie-Mellon</orgName></affiliation></author><author><name sortKey="Mulholland, Kim" sort="Mulholland, Kim" uniqKey="Mulholland K" first="Kim" last="Mulholland">Kim Mulholland</name><affiliation wicri:level="3"><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><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></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><wicri:noRegion>Zoersel</wicri:noRegion></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><wicri:noRegion>Bangkok</wicri:noRegion></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><wicri:noRegion>Dakar-Fann</wicri:noRegion></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><wicri:noRegion>VIC</wicri:noRegion></affiliation></author><author><name sortKey="Sheehan, Mark" sort="Sheehan, Mark" uniqKey="Sheehan M" first="Mark" last="Sheehan">Mark Sheehan</name><affiliation wicri:level="4"><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><placeName><settlement type="city">Oxford</settlement><region type="country">Angleterre</region><region type="comté" nuts="2">Oxfordshire</region><settlement type="city">Oxford</settlement></placeName><orgName type="university">Université d'Oxford</orgName></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="3"><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><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></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><affiliations><list><country><li>Afrique du Sud</li><li>Australie</li><li>Belgique</li><li>Canada</li><li>Chili</li><li>Inde</li><li>Mexique</li><li>Royaume-Uni</li><li>Suisse</li><li>Sénégal</li><li>Thaïlande</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Grand Londres</li><li>Maryland</li><li>Ontario</li><li>Oxfordshire</li><li>Pennsylvanie</li><li>État de New York</li></region><settlement><li>Londres</li><li>New York</li><li>Oxford</li><li>Pittsburgh</li><li>Toronto</li></settlement><orgName><li>Université Carnegie-Mellon</li><li>Université Columbia</li><li>Université d'Oxford</li><li>Université de Toronto</li></orgName></list><tree><country name="Royaume-Uni"><noRegion><name sortKey="Rid, Annette" sort="Rid, Annette" uniqKey="Rid A" first="Annette" last="Rid">Annette Rid</name></noRegion><name sortKey="Mulholland, Kim" sort="Mulholland, Kim" uniqKey="Mulholland K" first="Kim" last="Mulholland">Kim Mulholland</name><name sortKey="Sheehan, Mark" sort="Sheehan, Mark" uniqKey="Sheehan M" first="Mark" last="Sheehan">Mark Sheehan</name><name sortKey="Smith, Peter G" sort="Smith, Peter G" uniqKey="Smith P" first="Peter G" last="Smith">Peter G. Smith</name></country><country name="Suisse"><noRegion><name sortKey="Saxena, Abha" sort="Saxena, Abha" uniqKey="Saxena A" first="Abha" last="Saxena">Abha Saxena</name></noRegion><name sortKey="Bouesseau, Marie Charlotte" sort="Bouesseau, Marie Charlotte" uniqKey="Bouesseau M" first="Marie-Charlotte" last="Bouesseau">Marie-Charlotte Bouesseau</name></country><country name="États-Unis"><region name="Maryland"><name sortKey="Baqui, Abdhullah H" sort="Baqui, Abdhullah H" uniqKey="Baqui A" first="Abdhullah H" last="Baqui">Abdhullah H. Baqui</name></region><name sortKey="Caplan, Arthur" sort="Caplan, Arthur" uniqKey="Caplan A" first="Arthur" last="Caplan">Arthur Caplan</name><name sortKey="Colgrove, James" sort="Colgrove, James" uniqKey="Colgrove J" first="James" last="Colgrove">James Colgrove</name><name sortKey="London, Alex John" sort="London, Alex John" uniqKey="London A" first="Alex John" last="London">Alex John London</name></country><country name="Canada"><region name="Ontario"><name sortKey="Bhan, Anant" sort="Bhan, Anant" uniqKey="Bhan A" first="Anant" last="Bhan">Anant Bhan</name></region><name sortKey="Green, Shane K" sort="Green, Shane K" uniqKey="Green S" first="Shane K" last="Green">Shane K. Green</name></country><country name="Australie"><noRegion><name sortKey="Bines, Julie" sort="Bines, Julie" uniqKey="Bines J" first="Julie" last="Bines">Julie Bines</name></noRegion><name sortKey="Loh, Patricia" sort="Loh, Patricia" uniqKey="Loh P" first="Patricia" last="Loh">Patricia Loh</name><name sortKey="Selgelid, Michael" sort="Selgelid, Michael" uniqKey="Selgelid M" first="Michael" last="Selgelid">Michael Selgelid</name></country><country name="Afrique du Sud"><noRegion><name sortKey="Dhai, Ames" sort="Dhai, Ames" uniqKey="Dhai A" first="Ames" last="Dhai">Ames Dhai</name></noRegion></country><country name="Mexique"><noRegion><name sortKey="Gomez Diaz, Rita" sort="Gomez Diaz, Rita" uniqKey="Gomez Diaz R" first="Rita" last="Gomez-Diaz">Rita Gomez-Diaz</name></noRegion></country><country name="Inde"><noRegion><name sortKey="Kang, Gagandeep" sort="Kang, Gagandeep" uniqKey="Kang G" first="Gagandeep" last="Kang">Gagandeep Kang</name></noRegion></country><country name="Chili"><noRegion><name sortKey="Lagos, Rosanna" sort="Lagos, Rosanna" uniqKey="Lagos R" first="Rosanna" last="Lagos">Rosanna Lagos</name></noRegion></country><country name="Belgique"><noRegion><name sortKey="Neels, Pieter" sort="Neels, Pieter" uniqKey="Neels P" first="Pieter" last="Neels">Pieter Neels</name></noRegion></country><country name="Thaïlande"><noRegion><name sortKey="Pitisuttithum, Punee" sort="Pitisuttithum, Punee" uniqKey="Pitisuttithum P" first="Punee" last="Pitisuttithum">Punee Pitisuttithum</name></noRegion></country><country name="Sénégal"><noRegion><name sortKey="Sarr, Samba Cor" sort="Sarr, Samba Cor" uniqKey="Sarr S" first="Samba Cor" last="Sarr">Samba Cor Sarr</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Amérique/explor/PittsburghV1/Data/Main/Exploration
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 001B09 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 001B09 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Amérique
|area= PittsburghV1
|flux= Main
|étape= Exploration
|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/Main/Exploration/RBID.i -Sk "pubmed:24768580" \
| HfdSelect -Kh $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd \
| NlmPubMed2Wicri -a PittsburghV1
| This area was generated with Dilib version V0.6.38. |  |