Motivation for participating in phase 1 vaccine trials: Comparison of an influenza and an Ebola randomized controlled trial.
Identifieur interne : 000027 ( Main/Curation ); précédent : 000026; suivant : 000028Motivation for participating in phase 1 vaccine trials: Comparison of an influenza and an Ebola randomized controlled trial.
Auteurs : A. Cattapan [Canada] ; K. Browne [Canada] ; D M Halperin [Canada] ; A. Di Castri [Canada] ; P. Fullsack [Canada] ; J. Graham [Canada] ; J M Langley [Canada] ; B A Taylor [Canada] ; S A Mcneil [Canada] ; S A Halperin [Canada]Source :
- Vaccine [ 1873-2518 ] ; 2019.
Descripteurs français
- KwdFr :
- Adolescent, Adulte, Adulte d'âge moyen, Altruisme, Canada, Enquêtes et questionnaires, Essais cliniques de phase I comme sujet, Essais contrôlés randomisés comme sujet, Femelle, Fièvre hémorragique à virus Ebola (), Flambées de maladies (), Grippe humaine (), Humains, Jeune adulte, Motivation, Mâle, Participation du patient (psychologie), Sélection de patients, Vaccins antigrippaux (administration et posologie), Vaccins contre la maladie à virus Ebola (administration et posologie), Volontaires sains (psychologie).
- MESH :
- administration et posologie : Vaccins antigrippaux, Vaccins contre la maladie à virus Ebola.
- psychologie : Participation du patient, Volontaires sains.
- Adolescent, Adulte, Adulte d'âge moyen, Altruisme, Canada, Enquêtes et questionnaires, Essais cliniques de phase I comme sujet, Essais contrôlés randomisés comme sujet, Femelle, Fièvre hémorragique à virus Ebola, Flambées de maladies, Grippe humaine, Humains, Jeune adulte, Motivation, Mâle, Sélection de patients.
- Wicri :
- geographic : Canada.
English descriptors
- KwdEn :
- Adolescent, Adult, Altruism, Canada, Clinical Trials, Phase I as Topic, Disease Outbreaks (prevention & control), Ebola Vaccines (administration & dosage), Female, Healthy Volunteers (psychology), Hemorrhagic Fever, Ebola (prevention & control), Humans, Influenza Vaccines (administration & dosage), Influenza, Human (prevention & control), Male, Middle Aged, Motivation, Patient Participation (psychology), Patient Selection, Randomized Controlled Trials as Topic, Surveys and Questionnaires, Young Adult.
- MESH :
- chemical , administration & dosage : Ebola Vaccines, Influenza Vaccines.
- geographic : Canada.
- prevention & control : Disease Outbreaks, Hemorrhagic Fever, Ebola, Influenza, Human.
- psychology : Healthy Volunteers, Patient Participation.
- Adolescent, Adult, Altruism, Clinical Trials, Phase I as Topic, Female, Humans, Male, Middle Aged, Motivation, Patient Selection, Randomized Controlled Trials as Topic, Surveys and Questionnaires, Young Adult.
Abstract
INTRODUCTION/HYPOTHESIS
Recruitment of participants into phase 1 vaccine clinical trials can be challenging since these vaccines have not been used in humans and there is no perceived benefit to the participant. Occasionally, as was the case with a phase 1 clinical trial of an Ebola vaccine in Halifax, Canada, during the 2014-2016 West African Ebola virus outbreak, recruitment is less difficult. In this study, we explored the motivations of participants in two phase 1 vaccine trials that were concurrently enrolling at the same centre and compared the motivations of participants in a high-profile phase 1 Ebola vaccine trial to those in a less high-profile phase 1 adjuvanted seasonal influenza vaccine study.
METHODS
An online survey which included participants' prior experience with clinical trials, motivations to participate (including financial incentives), and demographic information was developed to examine the motivations of healthy participants in two phase 1 clinical vaccine trials conducted at the Canadian Center for Vaccinology in Halifax, Nova Scotia. Participants were invited via email to complete the online survey. Readability and clarity were assessed through pilot testing.
RESULTS
A total of 49 (55.7%) of 88 participants of the two studies completed the survey (22 [55%] of 40 participants from the Ebola vaccine study and 27 [56.3%] of 48 from the adjuvanted influenza vaccine study). Motivations that were most frequently ranked among participants' top three in both trials were (1) wanting to contribute to the health of others, (2) wanting to participate in something important, (3) wanting to contribute to the advancement of science, and (4) wanting to receive an incentive such as money or a tablet.
CONCLUSIONS/RECOMMENDATIONS
Although media attention and financial compensation were more often cited by Ebola vaccine trial participants as a reason to participate, both altruistic and self-interested factors were important motivations for participants in their decision to participate in a phase 1 vaccine clinical trial.
DOI: 10.1016/j.vaccine.2018.11.014
PubMed: 30528592
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<author><name sortKey="Taylor, B A" sort="Taylor, B A" uniqKey="Taylor B" first="B A" last="Taylor">B A Taylor</name>
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<country xml:lang="fr">Canada</country>
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<country xml:lang="fr">Canada</country>
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<series><title level="j">Vaccine</title>
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<term>Clinical Trials, Phase I as Topic</term>
<term>Disease Outbreaks (prevention & control)</term>
<term>Ebola Vaccines (administration & dosage)</term>
<term>Female</term>
<term>Healthy Volunteers (psychology)</term>
<term>Hemorrhagic Fever, Ebola (prevention & control)</term>
<term>Humans</term>
<term>Influenza Vaccines (administration & dosage)</term>
<term>Influenza, Human (prevention & control)</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Motivation</term>
<term>Patient Participation (psychology)</term>
<term>Patient Selection</term>
<term>Randomized Controlled Trials as Topic</term>
<term>Surveys and Questionnaires</term>
<term>Young Adult</term>
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<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Altruisme</term>
<term>Canada</term>
<term>Enquêtes et questionnaires</term>
<term>Essais cliniques de phase I comme sujet</term>
<term>Essais contrôlés randomisés comme sujet</term>
<term>Femelle</term>
<term>Fièvre hémorragique à virus Ebola ()</term>
<term>Flambées de maladies ()</term>
<term>Grippe humaine ()</term>
<term>Humains</term>
<term>Jeune adulte</term>
<term>Motivation</term>
<term>Mâle</term>
<term>Participation du patient (psychologie)</term>
<term>Sélection de patients</term>
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<term>Vaccins contre la maladie à virus Ebola (administration et posologie)</term>
<term>Volontaires sains (psychologie)</term>
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<term>Influenza Vaccines</term>
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<term>Hemorrhagic Fever, Ebola</term>
<term>Influenza, Human</term>
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<keywords scheme="MESH" qualifier="psychologie" xml:lang="fr"><term>Participation du patient</term>
<term>Volontaires sains</term>
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<term>Patient Participation</term>
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<term>Clinical Trials, Phase I as Topic</term>
<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
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<term>Patient Selection</term>
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<term>Surveys and Questionnaires</term>
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<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Altruisme</term>
<term>Canada</term>
<term>Enquêtes et questionnaires</term>
<term>Essais cliniques de phase I comme sujet</term>
<term>Essais contrôlés randomisés comme sujet</term>
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<term>Fièvre hémorragique à virus Ebola</term>
<term>Flambées de maladies</term>
<term>Grippe humaine</term>
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<front><div type="abstract" xml:lang="en"><p><b>INTRODUCTION/HYPOTHESIS</b>
</p>
<p>Recruitment of participants into phase 1 vaccine clinical trials can be challenging since these vaccines have not been used in humans and there is no perceived benefit to the participant. Occasionally, as was the case with a phase 1 clinical trial of an Ebola vaccine in Halifax, Canada, during the 2014-2016 West African Ebola virus outbreak, recruitment is less difficult. In this study, we explored the motivations of participants in two phase 1 vaccine trials that were concurrently enrolling at the same centre and compared the motivations of participants in a high-profile phase 1 Ebola vaccine trial to those in a less high-profile phase 1 adjuvanted seasonal influenza vaccine study.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>METHODS</b>
</p>
<p>An online survey which included participants' prior experience with clinical trials, motivations to participate (including financial incentives), and demographic information was developed to examine the motivations of healthy participants in two phase 1 clinical vaccine trials conducted at the Canadian Center for Vaccinology in Halifax, Nova Scotia. Participants were invited via email to complete the online survey. Readability and clarity were assessed through pilot testing.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>RESULTS</b>
</p>
<p>A total of 49 (55.7%) of 88 participants of the two studies completed the survey (22 [55%] of 40 participants from the Ebola vaccine study and 27 [56.3%] of 48 from the adjuvanted influenza vaccine study). Motivations that were most frequently ranked among participants' top three in both trials were (1) wanting to contribute to the health of others, (2) wanting to participate in something important, (3) wanting to contribute to the advancement of science, and (4) wanting to receive an incentive such as money or a tablet.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>CONCLUSIONS/RECOMMENDATIONS</b>
</p>
<p>Although media attention and financial compensation were more often cited by Ebola vaccine trial participants as a reason to participate, both altruistic and self-interested factors were important motivations for participants in their decision to participate in a phase 1 vaccine clinical trial.</p>
</div>
</front>
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<Month>08</Month>
<Day>12</Day>
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<Month>01</Month>
<Day>07</Day>
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<Title>Vaccine</Title>
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<Pagination><MedlinePgn>289-295</MedlinePgn>
</Pagination>
<ELocationID EIdType="pii" ValidYN="Y">S0264-410X(18)31527-5</ELocationID>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.vaccine.2018.11.014</ELocationID>
<Abstract><AbstractText Label="INTRODUCTION/HYPOTHESIS">Recruitment of participants into phase 1 vaccine clinical trials can be challenging since these vaccines have not been used in humans and there is no perceived benefit to the participant. Occasionally, as was the case with a phase 1 clinical trial of an Ebola vaccine in Halifax, Canada, during the 2014-2016 West African Ebola virus outbreak, recruitment is less difficult. In this study, we explored the motivations of participants in two phase 1 vaccine trials that were concurrently enrolling at the same centre and compared the motivations of participants in a high-profile phase 1 Ebola vaccine trial to those in a less high-profile phase 1 adjuvanted seasonal influenza vaccine study.</AbstractText>
<AbstractText Label="METHODS">An online survey which included participants' prior experience with clinical trials, motivations to participate (including financial incentives), and demographic information was developed to examine the motivations of healthy participants in two phase 1 clinical vaccine trials conducted at the Canadian Center for Vaccinology in Halifax, Nova Scotia. Participants were invited via email to complete the online survey. Readability and clarity were assessed through pilot testing.</AbstractText>
<AbstractText Label="RESULTS">A total of 49 (55.7%) of 88 participants of the two studies completed the survey (22 [55%] of 40 participants from the Ebola vaccine study and 27 [56.3%] of 48 from the adjuvanted influenza vaccine study). Motivations that were most frequently ranked among participants' top three in both trials were (1) wanting to contribute to the health of others, (2) wanting to participate in something important, (3) wanting to contribute to the advancement of science, and (4) wanting to receive an incentive such as money or a tablet.</AbstractText>
<AbstractText Label="CONCLUSIONS/RECOMMENDATIONS">Although media attention and financial compensation were more often cited by Ebola vaccine trial participants as a reason to participate, both altruistic and self-interested factors were important motivations for participants in their decision to participate in a phase 1 vaccine clinical trial.</AbstractText>
<CopyrightInformation>Copyright © 2018 Elsevier Ltd. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Cattapan</LastName>
<ForeName>A</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Novel Tech Ethics, Faculty of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada; Johnson Shoyama Graduate School of Public Policy, University of Saskatchewan, Saskatoon, Saskatchewan, Canada. Electronic address: alana.cattapan@usask.ca.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Browne</LastName>
<ForeName>K</ForeName>
<Initials>K</Initials>
<AffiliationInfo><Affiliation>Novel Tech Ethics, Faculty of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada; Department of Philosophy, Langara College, Vancouver, British Columbia, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Halperin</LastName>
<ForeName>D M</ForeName>
<Initials>DM</Initials>
<AffiliationInfo><Affiliation>School of Nursing, St. Francis Xavier University, Antigonish, Nova Scotia, Canada; Canadian Center for Vaccinology, Dalhousie University, IWK Health Centre, and the Nova Scotia Health Authority, Halifax, Nova Scotia, Canada; Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Di Castri</LastName>
<ForeName>A</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Canadian Center for Vaccinology, Dalhousie University, IWK Health Centre, and the Nova Scotia Health Authority, Halifax, Nova Scotia, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Fullsack</LastName>
<ForeName>P</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>Canadian Center for Vaccinology, Dalhousie University, IWK Health Centre, and the Nova Scotia Health Authority, Halifax, Nova Scotia, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Graham</LastName>
<ForeName>J</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Canadian Center for Vaccinology, Dalhousie University, IWK Health Centre, and the Nova Scotia Health Authority, Halifax, Nova Scotia, Canada; Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Langley</LastName>
<ForeName>J M</ForeName>
<Initials>JM</Initials>
<AffiliationInfo><Affiliation>Canadian Center for Vaccinology, Dalhousie University, IWK Health Centre, and the Nova Scotia Health Authority, Halifax, Nova Scotia, Canada; Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Taylor</LastName>
<ForeName>B A</ForeName>
<Initials>BA</Initials>
<AffiliationInfo><Affiliation>Canadian Center for Vaccinology, Dalhousie University, IWK Health Centre, and the Nova Scotia Health Authority, Halifax, Nova Scotia, Canada; Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada; School of Nursing, Dalhousie University, Halifax, Nova Scotia, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>McNeil</LastName>
<ForeName>S A</ForeName>
<Initials>SA</Initials>
<AffiliationInfo><Affiliation>Canadian Center for Vaccinology, Dalhousie University, IWK Health Centre, and the Nova Scotia Health Authority, Halifax, Nova Scotia, Canada; Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Halperin</LastName>
<ForeName>S A</ForeName>
<Initials>SA</Initials>
<AffiliationInfo><Affiliation>Canadian Center for Vaccinology, Dalhousie University, IWK Health Centre, and the Nova Scotia Health Authority, Halifax, Nova Scotia, Canada; Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<PublicationTypeList><PublicationType UI="D003160">Comparative Study</PublicationType>
<PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2018</Year>
<Month>12</Month>
<Day>07</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="D046129">Ebola Vaccines</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D007252">Influenza Vaccines</NameOfSubstance>
</Chemical>
</ChemicalList>
<MeshHeadingList><MeshHeading><DescriptorName UI="D000293" MajorTopicYN="N">Adolescent</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000533" MajorTopicYN="N">Altruism</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D002170" MajorTopicYN="N" Type="Geographic">Canada</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D017321" MajorTopicYN="N">Clinical Trials, Phase I as Topic</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D004196" MajorTopicYN="N">Disease Outbreaks</DescriptorName>
<QualifierName UI="Q000517" MajorTopicYN="N">prevention & control</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D046129" MajorTopicYN="N">Ebola Vaccines</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D064368" MajorTopicYN="N">Healthy Volunteers</DescriptorName>
<QualifierName UI="Q000523" MajorTopicYN="Y">psychology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D019142" MajorTopicYN="N">Hemorrhagic Fever, Ebola</DescriptorName>
<QualifierName UI="Q000517" MajorTopicYN="N">prevention & control</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D007252" MajorTopicYN="N">Influenza Vaccines</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D007251" MajorTopicYN="N">Influenza, Human</DescriptorName>
<QualifierName UI="Q000517" MajorTopicYN="N">prevention & control</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D009042" MajorTopicYN="Y">Motivation</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D010358" MajorTopicYN="N">Patient Participation</DescriptorName>
<QualifierName UI="Q000523" MajorTopicYN="Y">psychology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D018579" MajorTopicYN="N">Patient Selection</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D016032" MajorTopicYN="N">Randomized Controlled Trials as Topic</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D011795" MajorTopicYN="N">Surveys and Questionnaires</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName>
</MeshHeading>
</MeshHeadingList>
<KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">Adjuvant</Keyword>
<Keyword MajorTopicYN="Y">Altruism</Keyword>
<Keyword MajorTopicYN="Y">Ebola vaccine</Keyword>
<Keyword MajorTopicYN="Y">Influenza vaccine</Keyword>
<Keyword MajorTopicYN="Y">Participant motivation</Keyword>
<Keyword MajorTopicYN="Y">Phase 1 clinical trials</Keyword>
</KeywordList>
</MedlineCitation>
<PubmedData><History><PubMedPubDate PubStatus="received"><Year>2018</Year>
<Month>06</Month>
<Day>27</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="revised"><Year>2018</Year>
<Month>11</Month>
<Day>03</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted"><Year>2018</Year>
<Month>11</Month>
<Day>06</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="pubmed"><Year>2018</Year>
<Month>12</Month>
<Day>12</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="medline"><Year>2019</Year>
<Month>8</Month>
<Day>14</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="entrez"><Year>2018</Year>
<Month>12</Month>
<Day>12</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
</History>
<PublicationStatus>ppublish</PublicationStatus>
<ArticleIdList><ArticleId IdType="pubmed">30528592</ArticleId>
<ArticleId IdType="pii">S0264-410X(18)31527-5</ArticleId>
<ArticleId IdType="doi">10.1016/j.vaccine.2018.11.014</ArticleId>
</ArticleIdList>
</PubmedData>
</pubmed>
</record>
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