A phase 1, randomized, observer blind, antigen and adjuvant dosage finding clinical trial to evaluate the safety and immunogenicity of an adjuvanted, trivalent subunit influenza vaccine in adults ≥ 65 years of age.
Identifieur interne : 000593 ( Main/Exploration ); précédent : 000592; suivant : 000594A phase 1, randomized, observer blind, antigen and adjuvant dosage finding clinical trial to evaluate the safety and immunogenicity of an adjuvanted, trivalent subunit influenza vaccine in adults ≥ 65 years of age.
Auteurs : Gillis Otten [États-Unis] ; Vincent Matassa [Australie] ; Max Ciarlet [États-Unis] ; Brett Leav [États-Unis]Source :
- Vaccine [ 1873-2518 ] ; 2020.
Abstract
OBJECTIVE
To assess the safety and immunogenicity of the MF59®-adjuvanted trivalent influenza vaccine (aTIV; Fluad®) compared with modified aTIV formulations.
METHODS
A total of 196 subjects ≥ 65 years were randomized to receive7different formulations of vaccine containing a range of adjuvant and antigen dosesby single injection, or divided into two injections at a single time point. The primary study objective was to compare the serologic response of different formulations of aTIV containing increased amounts of adjuvant and antigen21 days after vaccination. Subjects were followed for immunogenicity and safety for one year.
RESULTS
The highest immune response, as measured by hemagglutination inhibition (HI) assay, 3 weeks after vaccination was observed in subjects in Group 6 with GMT 382.2 (95% confidence interval [CI] 237.5 to 615.0), 552.3 (364.8 to 836.1), and 54.1 (36.9 to 79.4) against A/H1N1, A/H3N2, and B respectively. Rates of seroconversion were also generally highest in this treatment group: 75% (95% CI 55.1 to 89.3), 75% (55.1 to 89.3), and 42.9% (24.5 to 62.8), respectively, against A/H1N1, A/H3N2, and B strains. The highest incidence of solicited adverse events (AEs) was reported by subjects who received both the highest dosage of antigen in combination with the highest dosage of adjuvant at the same site: 67.9% and 57.1% in Groups 4 and 6, respectively. The majority of solicited AEs were mild to moderate in severity. The number of unsolicited AEs was similar across the different dosages.
CONCLUSION
In this phase I trial of adults ≥ 65 years of age who received increased adjuvant and antigen dosages relative to the licensed aTIV, increased dosage of MF59 resulted in increased immunogenicity against all 3 components of seasonal influenza vaccine. The increase in immunogenicity was accompanied by an increase in the incidence of local reactogenicity.
DOI: 10.1016/j.vaccine.2019.10.058
PubMed: 31679865
Affiliations:
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Electronic address: Gillis.Otten@Seqirus.com.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Seqirus Inc., 50 Hampshire Street, Cambridge, MA 02139</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Matassa, Vincent" sort="Matassa, Vincent" uniqKey="Matassa V" first="Vincent" last="Matassa">Vincent Matassa</name><affiliation wicri:level="1"><nlm:affiliation>Seqirus Australia, 63 Poplar Road, Parkville, Victoria 3052, Australia. Electronic address: Vince.Matassa@Seqirus.com.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Seqirus Australia, 63 Poplar Road, Parkville, Victoria 3052</wicri:regionArea><wicri:noRegion>Victoria 3052</wicri:noRegion></affiliation></author><author><name sortKey="Ciarlet, Max" sort="Ciarlet, Max" uniqKey="Ciarlet M" first="Max" last="Ciarlet">Max Ciarlet</name><affiliation wicri:level="2"><nlm:affiliation>Novartis Vaccines and Diagnostics, 45 Sidney Street, Cambridge, MA 02139, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Novartis Vaccines and Diagnostics, 45 Sidney Street, Cambridge, MA 02139</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Leav, Brett" sort="Leav, Brett" uniqKey="Leav B" first="Brett" last="Leav">Brett Leav</name><affiliation wicri:level="2"><nlm:affiliation>Seqirus Inc., 50 Hampshire Street, Cambridge, MA 02139, United States. 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Electronic address: Gillis.Otten@Seqirus.com.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Seqirus Inc., 50 Hampshire Street, Cambridge, MA 02139</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Matassa, Vincent" sort="Matassa, Vincent" uniqKey="Matassa V" first="Vincent" last="Matassa">Vincent Matassa</name><affiliation wicri:level="1"><nlm:affiliation>Seqirus Australia, 63 Poplar Road, Parkville, Victoria 3052, Australia. Electronic address: Vince.Matassa@Seqirus.com.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Seqirus Australia, 63 Poplar Road, Parkville, Victoria 3052</wicri:regionArea><wicri:noRegion>Victoria 3052</wicri:noRegion></affiliation></author><author><name sortKey="Ciarlet, Max" sort="Ciarlet, Max" uniqKey="Ciarlet M" first="Max" last="Ciarlet">Max Ciarlet</name><affiliation wicri:level="2"><nlm:affiliation>Novartis Vaccines and Diagnostics, 45 Sidney Street, Cambridge, MA 02139, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Novartis Vaccines and Diagnostics, 45 Sidney Street, Cambridge, MA 02139</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Leav, Brett" sort="Leav, Brett" uniqKey="Leav B" first="Brett" last="Leav">Brett Leav</name><affiliation wicri:level="2"><nlm:affiliation>Seqirus Inc., 50 Hampshire Street, Cambridge, MA 02139, United States. Electronic address: Brett.Leav@Seqirus.com.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Seqirus Inc., 50 Hampshire Street, Cambridge, MA 02139</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author></analytic><series><title level="j">Vaccine</title><idno type="eISSN">1873-2518</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"><p><b>OBJECTIVE</b></p><p>To assess the safety and immunogenicity of the MF59®-adjuvanted trivalent influenza vaccine (aTIV; Fluad®) compared with modified aTIV formulations.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>A total of 196 subjects ≥ 65 years were randomized to receive7different formulations of vaccine containing a range of adjuvant and antigen dosesby single injection, or divided into two injections at a single time point. The primary study objective was to compare the serologic response of different formulations of aTIV containing increased amounts of adjuvant and antigen21 days after vaccination. Subjects were followed for immunogenicity and safety for one year.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>The highest immune response, as measured by hemagglutination inhibition (HI) assay, 3 weeks after vaccination was observed in subjects in Group 6 with GMT 382.2 (95% confidence interval [CI] 237.5 to 615.0), 552.3 (364.8 to 836.1), and 54.1 (36.9 to 79.4) against A/H1N1, A/H3N2, and B respectively. Rates of seroconversion were also generally highest in this treatment group: 75% (95% CI 55.1 to 89.3), 75% (55.1 to 89.3), and 42.9% (24.5 to 62.8), respectively, against A/H1N1, A/H3N2, and B strains. The highest incidence of solicited adverse events (AEs) was reported by subjects who received both the highest dosage of antigen in combination with the highest dosage of adjuvant at the same site: 67.9% and 57.1% in Groups 4 and 6, respectively. The majority of solicited AEs were mild to moderate in severity. The number of unsolicited AEs was similar across the different dosages.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSION</b></p><p>In this phase I trial of adults ≥ 65 years of age who received increased adjuvant and antigen dosages relative to the licensed aTIV, increased dosage of MF59 resulted in increased immunogenicity against all 3 components of seasonal influenza vaccine. The increase in immunogenicity was accompanied by an increase in the incidence of local reactogenicity.</p></div></front></TEI><pubmed><MedlineCitation Status="In-Process" Owner="NLM"><PMID Version="1">31679865</PMID><DateRevised><Year>2020</Year><Month>06</Month><Day>30</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1873-2518</ISSN><JournalIssue CitedMedium="Internet"><Volume>38</Volume><Issue>3</Issue><PubDate><Year>2020</Year><Month>01</Month><Day>16</Day></PubDate></JournalIssue><Title>Vaccine</Title><ISOAbbreviation>Vaccine</ISOAbbreviation></Journal><ArticleTitle>A phase 1, randomized, observer blind, antigen and adjuvant dosage finding clinical trial to evaluate the safety and immunogenicity of an adjuvanted, trivalent subunit influenza vaccine in adults ≥ 65 years of age.</ArticleTitle><Pagination><MedlinePgn>578-587</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S0264-410X(19)31438-0</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.vaccine.2019.10.058</ELocationID><Abstract><AbstractText Label="OBJECTIVE">To assess the safety and immunogenicity of the MF59®-adjuvanted trivalent influenza vaccine (aTIV; Fluad®) compared with modified aTIV formulations.</AbstractText><AbstractText Label="METHODS">A total of 196 subjects ≥ 65 years were randomized to receive7different formulations of vaccine containing a range of adjuvant and antigen dosesby single injection, or divided into two injections at a single time point. The primary study objective was to compare the serologic response of different formulations of aTIV containing increased amounts of adjuvant and antigen21 days after vaccination. Subjects were followed for immunogenicity and safety for one year.</AbstractText><AbstractText Label="RESULTS">The highest immune response, as measured by hemagglutination inhibition (HI) assay, 3 weeks after vaccination was observed in subjects in Group 6 with GMT 382.2 (95% confidence interval [CI] 237.5 to 615.0), 552.3 (364.8 to 836.1), and 54.1 (36.9 to 79.4) against A/H1N1, A/H3N2, and B respectively. Rates of seroconversion were also generally highest in this treatment group: 75% (95% CI 55.1 to 89.3), 75% (55.1 to 89.3), and 42.9% (24.5 to 62.8), respectively, against A/H1N1, A/H3N2, and B strains. The highest incidence of solicited adverse events (AEs) was reported by subjects who received both the highest dosage of antigen in combination with the highest dosage of adjuvant at the same site: 67.9% and 57.1% in Groups 4 and 6, respectively. The majority of solicited AEs were mild to moderate in severity. The number of unsolicited AEs was similar across the different dosages.</AbstractText><AbstractText Label="CONCLUSION">In this phase I trial of adults ≥ 65 years of age who received increased adjuvant and antigen dosages relative to the licensed aTIV, increased dosage of MF59 resulted in increased immunogenicity against all 3 components of seasonal influenza vaccine. The increase in immunogenicity was accompanied by an increase in the incidence of local reactogenicity.</AbstractText><CopyrightInformation>Copyright © 2019. Published by Elsevier Ltd.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Otten</LastName><ForeName>Gillis</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Seqirus Inc., 50 Hampshire Street, Cambridge, MA 02139, United States. Electronic address: Gillis.Otten@Seqirus.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Matassa</LastName><ForeName>Vincent</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Seqirus Australia, 63 Poplar Road, Parkville, Victoria 3052, Australia. Electronic address: Vince.Matassa@Seqirus.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ciarlet</LastName><ForeName>Max</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Novartis Vaccines and Diagnostics, 45 Sidney Street, Cambridge, MA 02139, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Leav</LastName><ForeName>Brett</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Seqirus Inc., 50 Hampshire Street, Cambridge, MA 02139, United States. Electronic address: Brett.Leav@Seqirus.com.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2019</Year><Month>11</Month><Day>01</Day></ArticleDate></Article><MedlineJournalInfo><Country>Netherlands</Country><MedlineTA>Vaccine</MedlineTA><NlmUniqueID>8406899</NlmUniqueID><ISSNLinking>0264-410X</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">Elderly</Keyword><Keyword MajorTopicYN="Y">Immunogenicity</Keyword><Keyword MajorTopicYN="Y">Influenza vaccine</Keyword><Keyword MajorTopicYN="Y">MF59</Keyword><Keyword MajorTopicYN="Y">Safety</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2019</Year><Month>03</Month><Day>28</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2019</Year><Month>10</Month><Day>18</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2019</Year><Month>10</Month><Day>21</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2019</Year><Month>11</Month><Day>5</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2019</Year><Month>11</Month><Day>5</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2019</Year><Month>11</Month><Day>5</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">31679865</ArticleId><ArticleId IdType="pii">S0264-410X(19)31438-0</ArticleId><ArticleId IdType="doi">10.1016/j.vaccine.2019.10.058</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Australie</li><li>États-Unis</li></country><region><li>Massachusetts</li></region></list><tree><country name="États-Unis"><region name="Massachusetts"><name sortKey="Otten, Gillis" sort="Otten, Gillis" uniqKey="Otten G" first="Gillis" last="Otten">Gillis Otten</name></region><name sortKey="Ciarlet, Max" sort="Ciarlet, Max" uniqKey="Ciarlet M" first="Max" last="Ciarlet">Max Ciarlet</name><name sortKey="Leav, Brett" sort="Leav, Brett" uniqKey="Leav B" first="Brett" last="Leav">Brett Leav</name></country><country name="Australie"><noRegion><name sortKey="Matassa, Vincent" sort="Matassa, Vincent" uniqKey="Matassa V" first="Vincent" last="Matassa">Vincent Matassa</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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