Evaluating use cases for human challenge trials in accelerating SARS-CoV-2 vaccine development.
Identifieur interne : 000073 ( Main/Corpus ); précédent : 000072; suivant : 000074Evaluating use cases for human challenge trials in accelerating SARS-CoV-2 vaccine development.
Auteurs : Linh Chi Nguyen ; Christopher W. Bakerlee ; T Greg Mckelvey ; Sophie M. Rose ; Alexander J. Norman ; Nicholas Joseph ; David Manheim ; Michael R. Mclaren ; Steven Jiang ; Conor F. Barnes ; Megan Kinniment ; Derek Foster ; Thomas C. Darton ; Josh MorrisonSource :
- 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
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Bakerlee</name><affiliation><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></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></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><nlm:affiliation>Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.</nlm:affiliation></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><nlm:affiliation>Independent scholar, Worthing, BN11 2HE, United Kingdom.</nlm:affiliation></affiliation></author><author><name sortKey="Joseph, Nicholas" sort="Joseph, Nicholas" uniqKey="Joseph N" first="Nicholas" last="Joseph">Nicholas Joseph</name><affiliation><nlm:affiliation>Independent scholar, Oakland, CA, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Manheim, David" sort="Manheim, David" uniqKey="Manheim D" first="David" last="Manheim">David Manheim</name><affiliation><nlm:affiliation>Health and Risk Communication Research Center, School of Public Health, University of Haifa, Haifa, Israel.</nlm:affiliation></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><nlm:affiliation>Department of Population Health and Pathobiology, North Carolina State University, Raleigh, NC, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Jiang, Steven" sort="Jiang, Steven" uniqKey="Jiang S" first="Steven" last="Jiang">Steven Jiang</name><affiliation><nlm:affiliation>Harvard Law School, Cambridge, MA, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Barnes, Conor F" sort="Barnes, Conor F" uniqKey="Barnes C" first="Conor F" last="Barnes">Conor F. 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Darton</name><affiliation><nlm:affiliation>Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, S10 2RX, United Kingdom.</nlm:affiliation></affiliation></author><author><name sortKey="Morrison, Josh" sort="Morrison, Josh" uniqKey="Morrison J" first="Josh" last="Morrison">Josh Morrison</name><affiliation><nlm:affiliation>Waitlist Zero, Brooklyn, NY, United States.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2020">2020</date><idno type="RBID">pubmed:32628748</idno><idno type="pmid">32628748</idno><idno type="doi">10.1093/cid/ciaa935</idno><idno type="wicri:Area/Main/Corpus">000073</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000073</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Evaluating use cases for human challenge trials in accelerating SARS-CoV-2 vaccine development.</title><author><name sortKey="Nguyen, Linh Chi" sort="Nguyen, Linh Chi" uniqKey="Nguyen L" first="Linh Chi" last="Nguyen">Linh Chi Nguyen</name><affiliation><nlm:affiliation>Department of Politics and International Relations, University of Oxford, Oxford, OX1 3UQ, United Kingdom.</nlm:affiliation></affiliation></author><author><name sortKey="Bakerlee, Christopher W" sort="Bakerlee, Christopher W" uniqKey="Bakerlee C" first="Christopher W" last="Bakerlee">Christopher W. Bakerlee</name><affiliation><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></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></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><nlm:affiliation>Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.</nlm:affiliation></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><nlm:affiliation>Independent scholar, Worthing, BN11 2HE, United Kingdom.</nlm:affiliation></affiliation></author><author><name sortKey="Joseph, Nicholas" sort="Joseph, Nicholas" uniqKey="Joseph N" first="Nicholas" last="Joseph">Nicholas Joseph</name><affiliation><nlm:affiliation>Independent scholar, Oakland, CA, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Manheim, David" sort="Manheim, David" uniqKey="Manheim D" first="David" last="Manheim">David Manheim</name><affiliation><nlm:affiliation>Health and Risk Communication Research Center, School of Public Health, University of Haifa, Haifa, Israel.</nlm:affiliation></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><nlm:affiliation>Department of Population Health and Pathobiology, North Carolina State University, Raleigh, NC, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Jiang, Steven" sort="Jiang, Steven" uniqKey="Jiang S" first="Steven" last="Jiang">Steven Jiang</name><affiliation><nlm:affiliation>Harvard Law School, Cambridge, MA, United States.</nlm:affiliation></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><nlm:affiliation>Independent scholar, Kelowna, BC, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Kinniment, Megan" sort="Kinniment, Megan" uniqKey="Kinniment M" first="Megan" last="Kinniment">Megan Kinniment</name><affiliation><nlm:affiliation>Department of Physics, University of Oxford, Oxford, OX1 3PJ, United Kingdom.</nlm:affiliation></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></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><nlm:affiliation>Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, S10 2RX, United Kingdom.</nlm:affiliation></affiliation></author><author><name sortKey="Morrison, Josh" sort="Morrison, Josh" uniqKey="Morrison J" first="Josh" last="Morrison">Josh Morrison</name><affiliation><nlm:affiliation>Waitlist Zero, Brooklyn, NY, United States.</nlm:affiliation></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></record>Pour manipuler ce document sous Unix (Dilib)
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