Safety and immunogenicity of 2010–2011 A/H1N1pdm09-containing trivalent inactivated influenza vaccine in adults previously given AS03-adjuvanted H1N1 2009 pandemic vaccine: results of a randomized trial.
Identifieur interne : 000326 ( Main/Exploration ); précédent : 000325; suivant : 000327Safety and immunogenicity of 2010–2011 A/H1N1pdm09-containing trivalent inactivated influenza vaccine in adults previously given AS03-adjuvanted H1N1 2009 pandemic vaccine: results of a randomized trial.
Auteurs : David W. Scheifele [Canada] ; Marc Dionne ; Brian J. Ward ; Curtis Cooper ; Otto G. Vanderkooi ; Yan Li ; Scott A. HalperinSource :
- Human vaccines & immunotherapeutics [ 2164-554X ] ; 2013.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Anticorps antiviraux (sang), Canada, Effets secondaires indésirables des médicaments (anatomopathologie), Effets secondaires indésirables des médicaments (épidémiologie), Femelle, Humains, Placebo (administration et posologie), Rappel de vaccin (), Rappel de vaccin (effets indésirables), Sous-type H1N1 du virus de la grippe A (immunologie), Vaccins antigrippaux (administration et posologie), Vaccins antigrippaux (effets indésirables), Vaccins antigrippaux (immunologie), Vaccins inactivés (administration et posologie), Vaccins inactivés (effets indésirables), Vaccins inactivés (immunologie), Études croisées.
- MESH :
- administration et posologie : Placebo, Vaccins antigrippaux, Vaccins inactivés.
- anatomopathologie : Effets secondaires indésirables des médicaments.
- effets indésirables : Rappel de vaccin, Vaccins antigrippaux, Vaccins inactivés.
- immunologie : Sous-type H1N1 du virus de la grippe A, Vaccins antigrippaux, Vaccins inactivés.
- sang : Anticorps antiviraux.
- épidémiologie : Effets secondaires indésirables des médicaments.
- Adulte, Adulte d'âge moyen, Canada, Femelle, Humains, Rappel de vaccin, Études croisées.
- Wicri :
- geographic : Canada.
English descriptors
- KwdEn :
- Adult, Antibodies, Viral (blood), Canada, Cross-Over Studies, Drug-Related Side Effects and Adverse Reactions (epidemiology), Drug-Related Side Effects and Adverse Reactions (pathology), Female, Humans, Immunization, Secondary (adverse effects), Immunization, Secondary (methods), Influenza A Virus, H1N1 Subtype (immunology), Influenza Vaccines (administration & dosage), Influenza Vaccines (adverse effects), Influenza Vaccines (immunology), Middle Aged, Placebos (administration & dosage), Vaccines, Inactivated (administration & dosage), Vaccines, Inactivated (adverse effects), Vaccines, Inactivated (immunology).
- MESH :
- chemical , administration & dosage : Influenza Vaccines, Placebos, Vaccines, Inactivated.
- chemical , adverse effects : Influenza Vaccines, Vaccines, Inactivated.
- chemical , blood : Antibodies, Viral.
- chemical , immunology : Influenza Vaccines, Vaccines, Inactivated.
- geographic : Canada.
- adverse effects : Immunization, Secondary.
- epidemiology : Drug-Related Side Effects and Adverse Reactions.
- immunology : Influenza A Virus, H1N1 Subtype.
- methods : Immunization, Secondary.
- pathology : Drug-Related Side Effects and Adverse Reactions.
- Adult, Cross-Over Studies, Female, Humans, Middle Aged.
Abstract
Many Canadians received a novel AS03-adjuvanted vaccine during the 2009 influenza A/H1N1 pandemic. Longer term implications of adjuvant use were unclear: would anti-H1N1 immune responses persist at high levels and, if so, could that result in increased or unusual adverse effects upon re-exposure to H1N1pdm09 antigen in the trivalent influenza vaccine (TIV) for 2010-11? To answer these questions, adults given AS03-adjuvanted H1N1pdm09 vaccine (Arepanrix®, GSK Canada) 9-10 mo earlier were enrolled in an evaluator-blinded, crossover trial to receive 2010-2011 non-adjuvanted TIV (Fluviral®, GSK Canada) and placebo 10 d apart, in random order. Adverse effects were monitored for 7 d after each injection. Vaccine-attributable adverse event (VAAE) rates were calculated by subtracting rates after placebo from those after vaccine. Blood was obtained pre-vaccination and 21-30 d afterward to measure hemagglutination inhibiting antibody titers. In total, 326 participants were enrolled and 321 completed the study. VAAE rates were low except for myalgia (18.6%) and injection site pain (63.2%). At baseline, H1N1pdm09 titers ≥ 40 were present in 176/325 subjects (54.2%, 95% confidence interval 48.6, 59.7), with a geometric mean titer (GMT) of 37.4 (95% CI 32.8, 42.6). Post-immunization, 96.0% (95% CI 92.3, 97.8) had H1N1pdm09 titers ≥ 40, with GMT of 167.4 (95% CI 148.7, 188.5). Responses to both influenza A strains in TIV were similar, implying no lasting effect of adjuvant exposure. In summary, titers ≥ 40 persisted in only half the participants 9-10 mo after adjuvanted pandemic vaccine but were restored in nearly all after TIV vaccination, with minimal increase in adverse effects.
DOI: 10.4161/hv.22619
PubMed: 23570051
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
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Longer term implications of adjuvant use were unclear: would anti-H1N1 immune responses persist at high levels and, if so, could that result in increased or unusual adverse effects upon re-exposure to H1N1pdm09 antigen in the trivalent influenza vaccine (TIV) for 2010-11? To answer these questions, adults given AS03-adjuvanted H1N1pdm09 vaccine (Arepanrix®, GSK Canada) 9-10 mo earlier were enrolled in an evaluator-blinded, crossover trial to receive 2010-2011 non-adjuvanted TIV (Fluviral®, GSK Canada) and placebo 10 d apart, in random order. Adverse effects were monitored for 7 d after each injection. Vaccine-attributable adverse event (VAAE) rates were calculated by subtracting rates after placebo from those after vaccine. Blood was obtained pre-vaccination and 21-30 d afterward to measure hemagglutination inhibiting antibody titers. In total, 326 participants were enrolled and 321 completed the study. VAAE rates were low except for myalgia (18.6%) and injection site pain (63.2%). At baseline, H1N1pdm09 titers ≥ 40 were present in 176/325 subjects (54.2%, 95% confidence interval 48.6, 59.7), with a geometric mean titer (GMT) of 37.4 (95% CI 32.8, 42.6). Post-immunization, 96.0% (95% CI 92.3, 97.8) had H1N1pdm09 titers ≥ 40, with GMT of 167.4 (95% CI 148.7, 188.5). Responses to both influenza A strains in TIV were similar, implying no lasting effect of adjuvant exposure. In summary, titers ≥ 40 persisted in only half the participants 9-10 mo after adjuvanted pandemic vaccine but were restored in nearly all after TIV vaccination, with minimal increase in adverse effects.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">23570051</PMID><DateCompleted><Year>2013</Year><Month>08</Month><Day>19</Day></DateCompleted><DateRevised><Year>2019</Year><Month>05</Month><Day>16</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">2164-554X</ISSN><JournalIssue CitedMedium="Internet"><Volume>9</Volume><Issue>1</Issue><PubDate><Year>2013</Year><Month>Jan</Month></PubDate></JournalIssue><Title>Human vaccines & immunotherapeutics</Title><ISOAbbreviation>Hum Vaccin Immunother</ISOAbbreviation></Journal><ArticleTitle>Safety and immunogenicity of 2010–2011 A/H1N1pdm09-containing trivalent inactivated influenza vaccine in adults previously given AS03-adjuvanted H1N1 2009 pandemic vaccine: results of a randomized trial.</ArticleTitle><Pagination><MedlinePgn>136-43</MedlinePgn></Pagination><Abstract><AbstractText>Many Canadians received a novel AS03-adjuvanted vaccine during the 2009 influenza A/H1N1 pandemic. Longer term implications of adjuvant use were unclear: would anti-H1N1 immune responses persist at high levels and, if so, could that result in increased or unusual adverse effects upon re-exposure to H1N1pdm09 antigen in the trivalent influenza vaccine (TIV) for 2010-11? To answer these questions, adults given AS03-adjuvanted H1N1pdm09 vaccine (Arepanrix®, GSK Canada) 9-10 mo earlier were enrolled in an evaluator-blinded, crossover trial to receive 2010-2011 non-adjuvanted TIV (Fluviral®, GSK Canada) and placebo 10 d apart, in random order. Adverse effects were monitored for 7 d after each injection. Vaccine-attributable adverse event (VAAE) rates were calculated by subtracting rates after placebo from those after vaccine. Blood was obtained pre-vaccination and 21-30 d afterward to measure hemagglutination inhibiting antibody titers. In total, 326 participants were enrolled and 321 completed the study. VAAE rates were low except for myalgia (18.6%) and injection site pain (63.2%). At baseline, H1N1pdm09 titers ≥ 40 were present in 176/325 subjects (54.2%, 95% confidence interval 48.6, 59.7), with a geometric mean titer (GMT) of 37.4 (95% CI 32.8, 42.6). Post-immunization, 96.0% (95% CI 92.3, 97.8) had H1N1pdm09 titers ≥ 40, with GMT of 167.4 (95% CI 148.7, 188.5). Responses to both influenza A strains in TIV were similar, implying no lasting effect of adjuvant exposure. In summary, titers ≥ 40 persisted in only half the participants 9-10 mo after adjuvanted pandemic vaccine but were restored in nearly all after TIV vaccination, with minimal increase in adverse effects.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Scheifele</LastName><ForeName>David W</ForeName><Initials>DW</Initials><AffiliationInfo><Affiliation>Vaccine Evaluation Center, BC Children’s Hospital, University of British Columbia, Vancouver, BC Canada. dscheifele@cfri.ca</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dionne</LastName><ForeName>Marc</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Ward</LastName><ForeName>Brian J</ForeName><Initials>BJ</Initials></Author><Author ValidYN="Y"><LastName>Cooper</LastName><ForeName>Curtis</ForeName><Initials>C</Initials></Author><Author ValidYN="Y"><LastName>Vanderkooi</LastName><ForeName>Otto G</ForeName><Initials>OG</Initials></Author><Author ValidYN="Y"><LastName>Li</LastName><ForeName>Yan</ForeName><Initials>Y</Initials></Author><Author ValidYN="Y"><LastName>Halperin</LastName><ForeName>Scott A</ForeName><Initials>SA</Initials></Author><Author ValidYN="Y"><CollectiveName>PHAC/CIHR Influenza Research Network</CollectiveName></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Hum Vaccin Immunother</MedlineTA><NlmUniqueID>101572652</NlmUniqueID><ISSNLinking>2164-5515</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000914">Antibodies, Viral</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007252">Influenza Vaccines</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D010919">Placebos</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D015164">Vaccines, Inactivated</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000914" MajorTopicYN="N">Antibodies, Viral</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D002170" MajorTopicYN="N" Type="Geographic">Canada</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D018592" MajorTopicYN="N">Cross-Over Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D064420" MajorTopicYN="N">Drug-Related Side Effects and Adverse Reactions</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName><QualifierName UI="Q000473" MajorTopicYN="N">pathology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007117" MajorTopicYN="N">Immunization, Secondary</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D053118" MajorTopicYN="N">Influenza A Virus, H1N1 Subtype</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007252" MajorTopicYN="N">Influenza Vaccines</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D010919" MajorTopicYN="N">Placebos</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D015164" MajorTopicYN="N">Vaccines, Inactivated</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading></MeshHeadingList><InvestigatorList><Investigator ValidYN="Y"><LastName>De Serres</LastName><ForeName>Gaston</ForeName><Initials>G</Initials></Investigator><Investigator ValidYN="Y"><LastName>Kellner</LastName><ForeName>James</ForeName><Initials>J</Initials></Investigator><Investigator ValidYN="Y"><LastName>Dobson</LastName><ForeName>Simon</ForeName><Initials>S</Initials></Investigator><Investigator ValidYN="Y"><LastName>Bastien</LastName><ForeName>Nathalie</ForeName><Initials>N</Initials></Investigator><Investigator ValidYN="Y"><LastName>Law</LastName><ForeName>Barbara</ForeName><Initials>B</Initials></Investigator></InvestigatorList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2013</Year><Month>4</Month><Day>10</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2013</Year><Month>4</Month><Day>10</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2013</Year><Month>8</Month><Day>21</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId 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IdType="pubmed">12744866</ArticleId></ArticleIdList></Reference></ReferenceList></PubmedData></pubmed><affiliations><list><country><li>Canada</li></country></list><tree><noCountry><name sortKey="Cooper, Curtis" sort="Cooper, Curtis" uniqKey="Cooper C" first="Curtis" last="Cooper">Curtis Cooper</name><name sortKey="Dionne, Marc" sort="Dionne, Marc" uniqKey="Dionne M" first="Marc" last="Dionne">Marc Dionne</name><name sortKey="Halperin, Scott A" sort="Halperin, Scott A" uniqKey="Halperin S" first="Scott A" last="Halperin">Scott A. Halperin</name><name sortKey="Li, Yan" sort="Li, Yan" uniqKey="Li Y" first="Yan" last="Li">Yan Li</name><name sortKey="Vanderkooi, Otto G" sort="Vanderkooi, Otto G" uniqKey="Vanderkooi O" first="Otto G" last="Vanderkooi">Otto G. Vanderkooi</name><name sortKey="Ward, Brian J" sort="Ward, Brian J" uniqKey="Ward B" first="Brian J" last="Ward">Brian J. Ward</name></noCountry><country name="Canada"><noRegion><name sortKey="Scheifele, David W" sort="Scheifele, David W" uniqKey="Scheifele D" first="David W" last="Scheifele">David W. Scheifele</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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