PittsburghV1, Canada, Analysis, bibRecord, 000286

Placebo use in vaccine trials: Recommendations of a WHO expert panel

Identifieur interne : 000286 ( Canada/Analysis ); précédent : 000285; suivant : 000287

Placebo 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 [ 0264-410X ] ; 2014.

RBID : Pascal:14-0208013

Descripteurs français

Pascal (Inist)
- Vaccin.
Wicri :
- topic : Vaccin.

English descriptors

KwdEn :
- Vaccine.

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.

Affiliations:

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Le document en format XML

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<author><name sortKey="London, Alex John" sort="London, Alex John" uniqKey="London A" first="Alex John" last="London">Alex John London</name>
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<author><name sortKey="Neels, Pieter" sort="Neels, Pieter" uniqKey="Neels P" first="Pieter" last="Neels">Pieter Neels</name>
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<author><name sortKey="Smith, Peter G" sort="Smith, Peter G" uniqKey="Smith P" first="Peter G." last="Smith">Peter G. Smith</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Placebo use in vaccine trials: Recommendations of a WHO expert panel</title>
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<author><name sortKey="Gagandeep Kang" sort="Gagandeep Kang" uniqKey="Gagandeep Kang" last="Gagandeep Kang">GAGANDEEP KANG</name>
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<author><name sortKey="Lagos, Rosanna" sort="Lagos, Rosanna" uniqKey="Lagos R" first="Rosanna" last="Lagos">Rosanna Lagos</name>
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<author><name sortKey="Loh, Patricia" sort="Loh, Patricia" uniqKey="Loh P" first="Patricia" last="Loh">Patricia Loh</name>
<affiliation wicri:level="1"><inist:fA14 i1="14"><s1>Melbourne Law School, University of Melbourne</s1>
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<country>Australie</country>
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<country>États-Unis</country>
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<orgName type="university">Université Carnegie-Mellon</orgName>
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<author><name sortKey="Mulholland, Kim" sort="Mulholland, Kim" uniqKey="Mulholland K" first="Kim" last="Mulholland">Kim Mulholland</name>
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<country>Royaume-Uni</country>
<placeName><settlement type="city">Londres</settlement>
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<author><name sortKey="Neels, Pieter" sort="Neels, Pieter" uniqKey="Neels P" first="Pieter" last="Neels">Pieter Neels</name>
<affiliation wicri:level="1"><inist:fA14 i1="17"><s1>Vaccine Advice BVBA</s1>
<s2>Zoersel</s2>
<s3>BEL</s3>
<sZ>17 aut.</sZ>
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<country>Belgique</country>
<wicri:noRegion>Vaccine Advice BVBA</wicri:noRegion>
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</author>
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<country>Thaïlande</country>
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</author>
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<author><name sortKey="Sheehan, Mark" sort="Sheehan, Mark" uniqKey="Sheehan M" first="Mark" last="Sheehan">Mark Sheehan</name>
<affiliation wicri:level="4"><inist:fA14 i1="21"><s1>The Ethox Centre, University of Oxford</s1>
<s2>Oxford</s2>
<s3>GBR</s3>
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<country>Royaume-Uni</country>
<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>
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</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"><inist:fA14 i1="22"><s1>Medical Research Council (MRC) Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine</s1>
<s2>London</s2>
<s3>GBR</s3>
<sZ>22 aut.</sZ>
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<country>Royaume-Uni</country>
<placeName><settlement type="city">Londres</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Grand Londres</region>
</placeName>
</affiliation>
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<series><title level="j" type="main">Vaccine</title>
<title level="j" type="abbreviated">Vaccine</title>
<idno type="ISSN">0264-410X</idno>
<imprint><date when="2014">2014</date>
</imprint>
</series>
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</sourceDesc>
<seriesStmt><title level="j" type="main">Vaccine</title>
<title level="j" type="abbreviated">Vaccine</title>
<idno type="ISSN">0264-410X</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Vaccine</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Vaccin</term>
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<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Vaccin</term>
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</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>
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<tree><country name="Royaume-Uni"><noRegion><name sortKey="Rid, Annette" sort="Rid, Annette" uniqKey="Rid A" first="Annette" last="Rid">Annette Rid</name>
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<country name="États-Unis"><noRegion><name sortKey="Baqui, Abdhullah H" sort="Baqui, Abdhullah H" uniqKey="Baqui A" first="Abdhullah H." last="Baqui">Abdhullah H. Baqui</name>
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<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>
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<country name="Canada"><region name="Ontario"><name sortKey="Bhan, Anant" sort="Bhan, Anant" uniqKey="Bhan A" first="Anant" last="Bhan">Anant Bhan</name>
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<name sortKey="Green, Shane K" sort="Green, Shane K" uniqKey="Green S" first="Shane K." last="Green">Shane K. Green</name>
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<country name="Australie"><noRegion><name sortKey="Bines, Julie" sort="Bines, Julie" uniqKey="Bines J" first="Julie" last="Bines">Julie Bines</name>
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<name sortKey="Selgelid, Michael" sort="Selgelid, Michael" uniqKey="Selgelid M" first="Michael" last="Selgelid">Michael Selgelid</name>
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<country name="Afrique du Sud"><noRegion><name sortKey="Dhai, Ames" sort="Dhai, Ames" uniqKey="Dhai A" first="Ames" last="Dhai">Ames Dhai</name>
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Placebo use in vaccine trials: Recommendations of a WHO expert panel

Placebo use in vaccine trials: Recommendations of a WHO expert panel

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