Evaluating use cases for human challenge trials in accelerating SARS-CoV-2 vaccine development.
Identifieur interne : 000203 ( Main/Exploration ); précédent : 000202; suivant : 000204Evaluating use cases for human challenge trials in accelerating SARS-CoV-2 vaccine development.
Auteurs : Linh Chi Nguyen [Royaume-Uni] ; Christopher W. Bakerlee [États-Unis] ; T Greg Mckelvey ; Sophie M. Rose [États-Unis] ; Alexander J. Norman [Royaume-Uni] ; Nicholas Joseph [États-Unis] ; David Manheim [Israël] ; Michael R. Mclaren [États-Unis] ; Steven Jiang [États-Unis] ; Conor F. Barnes [Canada] ; Megan Kinniment [Royaume-Uni] ; Derek Foster ; Thomas C. Darton [Royaume-Uni] ; Josh Morrison [États-Unis]Source :
- Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [ 1537-6591 ] ; 2020.
Abstract
Human challenge trials (HCTs) have been proposed as a means to accelerate SARS-CoV-2 vaccine development. We identify and discuss three potential use cases of HCTs in the current pandemic: evaluating efficacy, converging on correlates of protection, and improving understanding of pathogenesis and the human immune response. We outline the limitations of HCTs and find that HCTs are likely to be most useful for vaccine candidates currently in preclinical stages of development. We conclude that, while currently limited in their application, there are scenarios in which HCTs would be extremely beneficial. Therefore, the option of conducting HCTs to accelerate SARS-CoV-2 vaccine development should be preserved. As HCTs require many months of preparation, we recommend an immediate effort to (1) establish guidelines for HCTs for COVID-19; (2) take the first steps toward HCTs, including preparing challenge virus and making preliminary logistical arrangements; and (3) commit to periodically re-evaluating the utility of HCTs.
DOI: 10.1093/cid/ciaa935
PubMed: 32628748
Affiliations:
- Canada, Israël, Royaume-Uni, États-Unis
- Angleterre, Californie, Caroline du Nord, Maryland, Massachusetts, Oxfordshire, État de New York
- Cambridge (Massachusetts), Oxford
- Université Harvard, Université d'Oxford
Links toward previous steps (curation, corpus...)
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Bakerlee</name><affiliation wicri:level="4"><nlm:affiliation>Department of Molecular and Cellular Biology, Harvard University, Cambridge, MA, and Department of Organismic and Evolutionary Biology, Harvard University, Cambridge, MA, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Molecular and Cellular Biology, Harvard University, Cambridge, MA, and Department of Organismic and Evolutionary Biology, Harvard University, Cambridge, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region><settlement type="city">Cambridge (Massachusetts)</settlement></placeName><orgName type="university">Université Harvard</orgName></affiliation></author><author><name sortKey="Mckelvey, T Greg" sort="Mckelvey, T Greg" uniqKey="Mckelvey T" first="T Greg" last="Mckelvey">T Greg Mckelvey</name><affiliation><nlm:affiliation>ASAPP, INC.</nlm:affiliation><wicri:noCountry code="subField">INC</wicri:noCountry></affiliation></author><author><name sortKey="Rose, Sophie M" sort="Rose, Sophie M" uniqKey="Rose S" first="Sophie M" last="Rose">Sophie M. Rose</name><affiliation wicri:level="2"><nlm:affiliation>Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Norman, Alexander J" sort="Norman, Alexander J" uniqKey="Norman A" first="Alexander J" last="Norman">Alexander J. Norman</name><affiliation wicri:level="1"><nlm:affiliation>Independent scholar, Worthing, BN11 2HE, United Kingdom.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Independent scholar, Worthing, BN11 2HE</wicri:regionArea><wicri:noRegion>BN11 2HE</wicri:noRegion></affiliation></author><author><name sortKey="Joseph, Nicholas" sort="Joseph, Nicholas" uniqKey="Joseph N" first="Nicholas" last="Joseph">Nicholas Joseph</name><affiliation wicri:level="2"><nlm:affiliation>Independent scholar, Oakland, CA, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Independent scholar, Oakland, CA</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Manheim, David" sort="Manheim, David" uniqKey="Manheim D" first="David" last="Manheim">David Manheim</name><affiliation wicri:level="1"><nlm:affiliation>Health and Risk Communication Research Center, School of Public Health, University of Haifa, Haifa, Israel.</nlm:affiliation><country xml:lang="fr">Israël</country><wicri:regionArea>Health and Risk Communication Research Center, School of Public Health, University of Haifa, Haifa</wicri:regionArea><wicri:noRegion>Haifa</wicri:noRegion></affiliation></author><author><name sortKey="Mclaren, Michael R" sort="Mclaren, Michael R" uniqKey="Mclaren M" first="Michael R" last="Mclaren">Michael R. Mclaren</name><affiliation wicri:level="2"><nlm:affiliation>Department of Population Health and Pathobiology, North Carolina State University, Raleigh, NC, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Population Health and Pathobiology, North Carolina State University, Raleigh, NC</wicri:regionArea><placeName><region type="state">Caroline du Nord</region></placeName></affiliation></author><author><name sortKey="Jiang, Steven" sort="Jiang, Steven" uniqKey="Jiang S" first="Steven" last="Jiang">Steven Jiang</name><affiliation wicri:level="2"><nlm:affiliation>Harvard Law School, Cambridge, MA, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Harvard Law School, Cambridge, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Barnes, Conor F" sort="Barnes, Conor F" uniqKey="Barnes C" first="Conor F" last="Barnes">Conor F. Barnes</name><affiliation wicri:level="1"><nlm:affiliation>Independent scholar, Kelowna, BC, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Independent scholar, Kelowna, BC</wicri:regionArea><wicri:noRegion>BC</wicri:noRegion></affiliation></author><author><name sortKey="Kinniment, Megan" sort="Kinniment, Megan" uniqKey="Kinniment M" first="Megan" last="Kinniment">Megan Kinniment</name><affiliation wicri:level="4"><nlm:affiliation>Department of Physics, University of Oxford, Oxford, OX1 3PJ, United Kingdom.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Physics, University of Oxford, Oxford, OX1 3PJ</wicri:regionArea><orgName type="university">Université d'Oxford</orgName><placeName><settlement type="city">Oxford</settlement><region type="nation">Angleterre</region><region type="région" nuts="1">Oxfordshire</region></placeName></affiliation></author><author><name sortKey="Foster, Derek" sort="Foster, Derek" uniqKey="Foster D" first="Derek" last="Foster">Derek Foster</name><affiliation><nlm:affiliation>Rethink Priorities, Redwood City, CA, United States, www.rethinkpriorities.org.</nlm:affiliation><wicri:noCountry code="subField">www.rethinkpriorities.org.</wicri:noCountry></affiliation></author><author><name sortKey="Darton, Thomas C" sort="Darton, Thomas C" uniqKey="Darton T" first="Thomas C" last="Darton">Thomas C. Darton</name><affiliation wicri:level="1"><nlm:affiliation>Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, S10 2RX, United Kingdom.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, S10 2RX</wicri:regionArea><wicri:noRegion>S10 2RX</wicri:noRegion></affiliation></author><author><name sortKey="Morrison, Josh" sort="Morrison, Josh" uniqKey="Morrison J" first="Josh" last="Morrison">Josh Morrison</name><affiliation wicri:level="2"><nlm:affiliation>Waitlist Zero, Brooklyn, NY, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Waitlist Zero, Brooklyn, NY</wicri:regionArea><placeName><region type="state">État de New York</region></placeName></affiliation></author></analytic><series><title level="j">Clinical infectious diseases : an official publication of the Infectious Diseases Society of America</title><idno type="eISSN">1537-6591</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Human challenge trials (HCTs) have been proposed as a means to accelerate SARS-CoV-2 vaccine development. We identify and discuss three potential use cases of HCTs in the current pandemic: evaluating efficacy, converging on correlates of protection, and improving understanding of pathogenesis and the human immune response. We outline the limitations of HCTs and find that HCTs are likely to be most useful for vaccine candidates currently in preclinical stages of development. We conclude that, while currently limited in their application, there are scenarios in which HCTs would be extremely beneficial. Therefore, the option of conducting HCTs to accelerate SARS-CoV-2 vaccine development should be preserved. As HCTs require many months of preparation, we recommend an immediate effort to (1) establish guidelines for HCTs for COVID-19; (2) take the first steps toward HCTs, including preparing challenge virus and making preliminary logistical arrangements; and (3) commit to periodically re-evaluating the utility of HCTs.</div></front></TEI><pubmed><MedlineCitation Status="Publisher" Owner="NLM"><PMID Version="1">32628748</PMID><DateRevised><Year>2020</Year><Month>07</Month><Day>06</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1537-6591</ISSN><JournalIssue CitedMedium="Internet"><PubDate><Year>2020</Year><Month>Jul</Month><Day>06</Day></PubDate></JournalIssue><Title>Clinical infectious diseases : an official publication of the Infectious Diseases Society of America</Title><ISOAbbreviation>Clin. Infect. Dis.</ISOAbbreviation></Journal><ArticleTitle>Evaluating use cases for human challenge trials in accelerating SARS-CoV-2 vaccine development.</ArticleTitle><ELocationID EIdType="pii" ValidYN="Y">ciaa935</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1093/cid/ciaa935</ELocationID><Abstract><AbstractText>Human challenge trials (HCTs) have been proposed as a means to accelerate SARS-CoV-2 vaccine development. We identify and discuss three potential use cases of HCTs in the current pandemic: evaluating efficacy, converging on correlates of protection, and improving understanding of pathogenesis and the human immune response. We outline the limitations of HCTs and find that HCTs are likely to be most useful for vaccine candidates currently in preclinical stages of development. We conclude that, while currently limited in their application, there are scenarios in which HCTs would be extremely beneficial. Therefore, the option of conducting HCTs to accelerate SARS-CoV-2 vaccine development should be preserved. As HCTs require many months of preparation, we recommend an immediate effort to (1) establish guidelines for HCTs for COVID-19; (2) take the first steps toward HCTs, including preparing challenge virus and making preliminary logistical arrangements; and (3) commit to periodically re-evaluating the utility of HCTs.</AbstractText><CopyrightInformation>© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Nguyen</LastName><ForeName>Linh Chi</ForeName><Initials>LC</Initials><AffiliationInfo><Affiliation>Department of Politics and International Relations, University of Oxford, Oxford, OX1 3UQ, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bakerlee</LastName><ForeName>Christopher W</ForeName><Initials>CW</Initials><AffiliationInfo><Affiliation>Department of Molecular and Cellular Biology, Harvard University, Cambridge, MA, and Department of Organismic and Evolutionary Biology, Harvard University, Cambridge, MA, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>McKelvey</LastName><ForeName>T Greg</ForeName><Initials>TG</Initials><AffiliationInfo><Affiliation>ASAPP, INC.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rose</LastName><ForeName>Sophie M</ForeName><Initials>SM</Initials><AffiliationInfo><Affiliation>Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Norman</LastName><ForeName>Alexander J</ForeName><Initials>AJ</Initials><AffiliationInfo><Affiliation>Independent scholar, Worthing, BN11 2HE, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Joseph</LastName><ForeName>Nicholas</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Independent scholar, Oakland, CA, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Manheim</LastName><ForeName>David</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Health and Risk Communication Research Center, School of Public Health, University of Haifa, Haifa, Israel.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>McLaren</LastName><ForeName>Michael R</ForeName><Initials>MR</Initials><AffiliationInfo><Affiliation>Department of Population Health and Pathobiology, North Carolina State University, Raleigh, NC, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jiang</LastName><ForeName>Steven</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Harvard Law School, Cambridge, MA, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Barnes</LastName><ForeName>Conor F</ForeName><Initials>CF</Initials><AffiliationInfo><Affiliation>Independent scholar, Kelowna, BC, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kinniment</LastName><ForeName>Megan</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Physics, University of Oxford, Oxford, OX1 3PJ, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Foster</LastName><ForeName>Derek</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Rethink Priorities, Redwood City, CA, United States, www.rethinkpriorities.org.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Darton</LastName><ForeName>Thomas C</ForeName><Initials>TC</Initials><AffiliationInfo><Affiliation>Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, S10 2RX, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Morrison</LastName><ForeName>Josh</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Waitlist Zero, Brooklyn, NY, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><CollectiveName>1Day Sooner Research Team</CollectiveName></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>07</Month><Day>06</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Clin Infect Dis</MedlineTA><NlmUniqueID>9203213</NlmUniqueID><ISSNLinking>1058-4838</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">COVID-19</Keyword><Keyword MajorTopicYN="N">Controlled Human Infection</Keyword><Keyword MajorTopicYN="N">Human Challenge Trial</Keyword><Keyword MajorTopicYN="N">Pandemic</Keyword><Keyword MajorTopicYN="N">Vaccine evaluation</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>05</Month><Day>26</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>7</Month><Day>7</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2020</Year><Month>7</Month><Day>7</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2020</Year><Month>7</Month><Day>7</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>aheadofprint</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">32628748</ArticleId><ArticleId IdType="pii">5868014</ArticleId><ArticleId IdType="doi">10.1093/cid/ciaa935</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Canada</li><li>Israël</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Californie</li><li>Caroline du Nord</li><li>Maryland</li><li>Massachusetts</li><li>Oxfordshire</li><li>État de New York</li></region><settlement><li>Cambridge (Massachusetts)</li><li>Oxford</li></settlement><orgName><li>Université Harvard</li><li>Université d'Oxford</li></orgName></list><tree><noCountry><name sortKey="Foster, Derek" sort="Foster, Derek" uniqKey="Foster D" first="Derek" last="Foster">Derek Foster</name><name sortKey="Mckelvey, T Greg" sort="Mckelvey, T Greg" uniqKey="Mckelvey T" first="T Greg" last="Mckelvey">T Greg Mckelvey</name></noCountry><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Nguyen, Linh Chi" sort="Nguyen, Linh Chi" uniqKey="Nguyen L" first="Linh Chi" last="Nguyen">Linh Chi Nguyen</name></region><name sortKey="Darton, Thomas C" sort="Darton, Thomas C" uniqKey="Darton T" first="Thomas C" last="Darton">Thomas C. Darton</name><name sortKey="Kinniment, Megan" sort="Kinniment, Megan" uniqKey="Kinniment M" first="Megan" last="Kinniment">Megan Kinniment</name><name sortKey="Norman, Alexander J" sort="Norman, Alexander J" uniqKey="Norman A" first="Alexander J" last="Norman">Alexander J. Norman</name></country><country name="États-Unis"><region name="Massachusetts"><name sortKey="Bakerlee, Christopher W" sort="Bakerlee, Christopher W" uniqKey="Bakerlee C" first="Christopher W" last="Bakerlee">Christopher W. Bakerlee</name></region><name sortKey="Jiang, Steven" sort="Jiang, Steven" uniqKey="Jiang S" first="Steven" last="Jiang">Steven Jiang</name><name sortKey="Joseph, Nicholas" sort="Joseph, Nicholas" uniqKey="Joseph N" first="Nicholas" last="Joseph">Nicholas Joseph</name><name sortKey="Mclaren, Michael R" sort="Mclaren, Michael R" uniqKey="Mclaren M" first="Michael R" last="Mclaren">Michael R. Mclaren</name><name sortKey="Morrison, Josh" sort="Morrison, Josh" uniqKey="Morrison J" first="Josh" last="Morrison">Josh Morrison</name><name sortKey="Rose, Sophie M" sort="Rose, Sophie M" uniqKey="Rose S" first="Sophie M" last="Rose">Sophie M. Rose</name></country><country name="Israël"><noRegion><name sortKey="Manheim, David" sort="Manheim, David" uniqKey="Manheim D" first="David" last="Manheim">David Manheim</name></noRegion></country><country name="Canada"><noRegion><name sortKey="Barnes, Conor F" sort="Barnes, Conor F" uniqKey="Barnes C" first="Conor F" last="Barnes">Conor F. Barnes</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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|wiki= Sante
|area= CardioCovidV1
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|clé= pubmed:32628748
|texte= Evaluating use cases for human challenge trials in accelerating SARS-CoV-2 vaccine development.
}}
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