Identification of antigen and adjuvant doses resulting in optimal immunogenicity and antibody persistence up to 1 year after immunization with a pandemic A/H1N1 influenza vaccine in children 3 to < 9 years of age.
Identifieur interne : 000251 ( Main/Exploration ); précédent : 000250; suivant : 000252Identification of antigen and adjuvant doses resulting in optimal immunogenicity and antibody persistence up to 1 year after immunization with a pandemic A/H1N1 influenza vaccine in children 3 to < 9 years of age.
Auteurs : Cynthia Nassim [États-Unis] ; Shane Christensen ; Dan Henry ; Sandra Holmes ; Matthew Hohenboken ; Niranjan Kanesa-ThasanSource :
- The Pediatric infectious disease journal [ 1532-0987 ] ; 2012.
Descripteurs français
- KwdFr :
- Adjuvants immunologiques (administration et posologie), Adjuvants immunologiques (effets indésirables), Allemagne (MeSH), Anticorps antiviraux (sang), Enfant (MeSH), Enfant d'âge préscolaire (MeSH), Facteurs temps (MeSH), Femelle (MeSH), Grippe humaine (prévention et contrôle), Humains (MeSH), Immunisation (effets indésirables), Immunisation (méthodes), Mâle (MeSH), Méthode en simple aveugle (MeSH), Polysorbates (administration et posologie), Polysorbates (effets indésirables), Sous-type H1N1 du virus de la grippe A (immunologie), Squalène (administration et posologie), Squalène (effets indésirables), Tests d'inhibition de l'hémagglutination (MeSH), Vaccins antigrippaux (administration et posologie), Vaccins antigrippaux (effets indésirables), Vaccins antigrippaux (immunologie), États-Unis (MeSH).
- MESH :
- administration et posologie : Adjuvants immunologiques, Polysorbates, Squalène, Vaccins antigrippaux.
- effets indésirables : Adjuvants immunologiques, Immunisation, Polysorbates, Squalène, Vaccins antigrippaux.
- immunologie : Sous-type H1N1 du virus de la grippe A, Vaccins antigrippaux.
- méthodes : Immunisation.
- prévention et contrôle : Grippe humaine.
- sang : Anticorps antiviraux.
- Allemagne, Enfant, Enfant d'âge préscolaire, Facteurs temps, Femelle, Humains, Mâle, Méthode en simple aveugle, Tests d'inhibition de l'hémagglutination, États-Unis.
- Wicri :
- geographic : Allemagne, États-Unis.
English descriptors
- KwdEn :
- Adjuvants, Immunologic (administration & dosage), Adjuvants, Immunologic (adverse effects), Antibodies, Viral (blood), Child (MeSH), Child, Preschool (MeSH), Female (MeSH), Germany (MeSH), Hemagglutination Inhibition Tests (MeSH), Humans (MeSH), Immunization (adverse effects), Immunization (methods), Influenza A Virus, H1N1 Subtype (immunology), Influenza Vaccines (administration & dosage), Influenza Vaccines (adverse effects), Influenza Vaccines (immunology), Influenza, Human (prevention & control), Male (MeSH), Polysorbates (administration & dosage), Polysorbates (adverse effects), Single-Blind Method (MeSH), Squalene (administration & dosage), Squalene (adverse effects), Time Factors (MeSH), United States (MeSH).
- MESH :
- chemical , administration & dosage : Adjuvants, Immunologic, Influenza Vaccines, Polysorbates, Squalene.
- chemical , adverse effects : Adjuvants, Immunologic, Influenza Vaccines, Polysorbates, Squalene.
- chemical , blood : Antibodies, Viral.
- chemical , immunology : Influenza Vaccines.
- geographic : Germany, United States.
- adverse effects : Immunization.
- immunology : Influenza A Virus, H1N1 Subtype.
- methods : Immunization.
- prevention & control : Influenza, Human.
- Child, Child, Preschool, Female, Hemagglutination Inhibition Tests, Humans, Male, Single-Blind Method, Time Factors.
Abstract
BACKGROUND
In the development of pediatric A/H1N1 influenza vaccines, this study was performed to identify antigen and adjuvant doses providing optimal immunogenicity and antibody persistence to ensure long-term immunity after immunization with an adjuvanted A/H1N1 vaccine in children 3 to <9 years of age.
METHODS
Healthy children (N = 1357) were immunized with 1 of 8 investigational vaccine formulations ranging in antigen (3.75-30 µg) and MF59 adjuvant (Novartis Vaccines, Marburg, Germany; 0, 50 and 100% of standard dose). Each participant received 2 vaccine doses given 3 weeks apart. Immunogenicity was analyzed by hemagglutination inhibition assay in sera drawn 3, 4 and 6 weeks after first vaccination. Long-term antibody persistence was assessed 6 and 12 months after immunization. Vaccine safety was monitored throughout the study.
RESULTS
All MF59-adjuvanted vaccines were well tolerated and highly immunogenic, with adjuvanted formulations inducing antibody titers statistically superior to those of the nonadjuvanted vaccines. Each MF59-adjuvanted vaccine met all the US and European licensure criteria for influenza vaccines 3 weeks after the administration of a single dose; all nonadjuvanted formulations failed to meet licensure criteria at this time point. Antibody titers in response to a single vaccination with 7.5 µg antigen and a full dose of MF59 continued to meet all US and European licensure criteria up to 1 year after immunization.
CONCLUSION
A single dose of vaccine containing 7.5 µg A/California/7/2009 (H1N1) antigen and a full dose of MF59 adjuvant was found to be optimal for children 3 to <9 years of age.
DOI: 10.1097/INF.0b013e31824b9545
PubMed: 22418661
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
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xml:lang="fr"><term>Adjuvants immunologiques (administration et posologie)</term><term>Adjuvants immunologiques (effets indésirables)</term><term>Allemagne (MeSH)</term><term>Anticorps antiviraux (sang)</term><term>Enfant (MeSH)</term><term>Enfant d'âge préscolaire (MeSH)</term><term>Facteurs temps (MeSH)</term><term>Femelle (MeSH)</term><term>Grippe humaine (prévention et contrôle)</term><term>Humains (MeSH)</term><term>Immunisation (effets indésirables)</term><term>Immunisation (méthodes)</term><term>Mâle (MeSH)</term><term>Méthode en simple aveugle (MeSH)</term><term>Polysorbates (administration et posologie)</term><term>Polysorbates (effets indésirables)</term><term>Sous-type H1N1 du virus de la grippe A (immunologie)</term><term>Squalène (administration et posologie)</term><term>Squalène (effets indésirables)</term><term>Tests d'inhibition de l'hémagglutination (MeSH)</term><term>Vaccins antigrippaux (administration et posologie)</term><term>Vaccins antigrippaux (effets 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xml:lang="en"><p><b>BACKGROUND</b></p><p>In the development of pediatric A/H1N1 influenza vaccines, this study was performed to identify antigen and adjuvant doses providing optimal immunogenicity and antibody persistence to ensure long-term immunity after immunization with an adjuvanted A/H1N1 vaccine in children 3 to <9 years of age.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>Healthy children (N = 1357) were immunized with 1 of 8 investigational vaccine formulations ranging in antigen (3.75-30 µg) and MF59 adjuvant (Novartis Vaccines, Marburg, Germany; 0, 50 and 100% of standard dose). Each participant received 2 vaccine doses given 3 weeks apart. Immunogenicity was analyzed by hemagglutination inhibition assay in sera drawn 3, 4 and 6 weeks after first vaccination. Long-term antibody persistence was assessed 6 and 12 months after immunization. Vaccine safety was monitored throughout the study.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>All MF59-adjuvanted vaccines were well tolerated and highly immunogenic, with adjuvanted formulations inducing antibody titers statistically superior to those of the nonadjuvanted vaccines. Each MF59-adjuvanted vaccine met all the US and European licensure criteria for influenza vaccines 3 weeks after the administration of a single dose; all nonadjuvanted formulations failed to meet licensure criteria at this time point. Antibody titers in response to a single vaccination with 7.5 µg antigen and a full dose of MF59 continued to meet all US and European licensure criteria up to 1 year after immunization.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSION</b></p><p>A single dose of vaccine containing 7.5 µg A/California/7/2009 (H1N1) antigen and a full dose of MF59 adjuvant was found to be optimal for children 3 to <9 years of age.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">22418661</PMID><DateCompleted><Year>2012</Year><Month>07</Month><Day>16</Day></DateCompleted><DateRevised><Year>2013</Year><Month>11</Month><Day>21</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1532-0987</ISSN><JournalIssue CitedMedium="Internet"><Volume>31</Volume><Issue>4</Issue><PubDate><Year>2012</Year><Month>Apr</Month></PubDate></JournalIssue><Title>The Pediatric infectious disease journal</Title><ISOAbbreviation>Pediatr. Infect. Dis. J.</ISOAbbreviation></Journal><ArticleTitle>Identification of antigen and adjuvant doses resulting in optimal immunogenicity and antibody persistence up to 1 year after immunization with a pandemic A/H1N1 influenza vaccine in children 3 to < 9 years of age.</ArticleTitle><Pagination><MedlinePgn>e59-65</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1097/INF.0b013e31824b9545</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">In the development of pediatric A/H1N1 influenza vaccines, this study was performed to identify antigen and adjuvant doses providing optimal immunogenicity and antibody persistence to ensure long-term immunity after immunization with an adjuvanted A/H1N1 vaccine in children 3 to <9 years of age.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">Healthy children (N = 1357) were immunized with 1 of 8 investigational vaccine formulations ranging in antigen (3.75-30 µg) and MF59 adjuvant (Novartis Vaccines, Marburg, Germany; 0, 50 and 100% of standard dose). Each participant received 2 vaccine doses given 3 weeks apart. Immunogenicity was analyzed by hemagglutination inhibition assay in sera drawn 3, 4 and 6 weeks after first vaccination. Long-term antibody persistence was assessed 6 and 12 months after immunization. Vaccine safety was monitored throughout the study.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">All MF59-adjuvanted vaccines were well tolerated and highly immunogenic, with adjuvanted formulations inducing antibody titers statistically superior to those of the nonadjuvanted vaccines. Each MF59-adjuvanted vaccine met all the US and European licensure criteria for influenza vaccines 3 weeks after the administration of a single dose; all nonadjuvanted formulations failed to meet licensure criteria at this time point. Antibody titers in response to a single vaccination with 7.5 µg antigen and a full dose of MF59 continued to meet all US and European licensure criteria up to 1 year after immunization.</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">A single dose of vaccine containing 7.5 µg A/California/7/2009 (H1N1) antigen and a full dose of MF59 adjuvant was found to be optimal for children 3 to <9 years of age.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Nassim</LastName><ForeName>Cynthia</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Nassim and Associates, Pediatric Medicine, New Albany, IN, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Christensen</LastName><ForeName>Shane</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Henry</LastName><ForeName>Dan</ForeName><Initials>D</Initials></Author><Author ValidYN="Y"><LastName>Holmes</LastName><ForeName>Sandra</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Hohenboken</LastName><ForeName>Matthew</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Kanesa-Thasan</LastName><ForeName>Niranjan</ForeName><Initials>N</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</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>Pediatr Infect Dis J</MedlineTA><NlmUniqueID>8701858</NlmUniqueID><ISSNLinking>0891-3668</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000276">Adjuvants, Immunologic</NameOfSubstance></Chemical><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="C089950">MF59 oil emulsion</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D011136">Polysorbates</NameOfSubstance></Chemical><Chemical><RegistryNumber>7QWM220FJH</RegistryNumber><NameOfSubstance UI="D013185">Squalene</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000276" MajorTopicYN="N">Adjuvants, Immunologic</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000914" MajorTopicYN="N">Antibodies, Viral</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="Y">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D002648" MajorTopicYN="N">Child</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002675" MajorTopicYN="N">Child, Preschool</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005858" MajorTopicYN="N" Type="Geographic">Germany</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006385" MajorTopicYN="N">Hemagglutination Inhibition Tests</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007114" MajorTopicYN="N">Immunization</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000379" MajorTopicYN="N">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="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007251" MajorTopicYN="N">Influenza, Human</DescriptorName><QualifierName UI="Q000517" MajorTopicYN="Y">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011136" MajorTopicYN="N">Polysorbates</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016037" MajorTopicYN="N">Single-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013185" MajorTopicYN="N">Squalene</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D013997" MajorTopicYN="N">Time Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D014481" MajorTopicYN="N" Type="Geographic">United States</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2012</Year><Month>3</Month><Day>16</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2012</Year><Month>3</Month><Day>16</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2012</Year><Month>7</Month><Day>17</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">22418661</ArticleId><ArticleId IdType="doi">10.1097/INF.0b013e31824b9545</ArticleId><ArticleId IdType="pii">00006454-201204000-00015</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>États-Unis</li></country><region><li>Indiana</li></region></list><tree><noCountry><name sortKey="Christensen, Shane" sort="Christensen, Shane" uniqKey="Christensen S" first="Shane" last="Christensen">Shane Christensen</name><name sortKey="Henry, Dan" sort="Henry, Dan" uniqKey="Henry D" first="Dan" last="Henry">Dan Henry</name><name sortKey="Hohenboken, Matthew" sort="Hohenboken, Matthew" uniqKey="Hohenboken M" first="Matthew" last="Hohenboken">Matthew Hohenboken</name><name sortKey="Holmes, Sandra" sort="Holmes, Sandra" uniqKey="Holmes S" first="Sandra" last="Holmes">Sandra Holmes</name><name sortKey="Kanesa Thasan, Niranjan" sort="Kanesa Thasan, Niranjan" uniqKey="Kanesa Thasan N" first="Niranjan" last="Kanesa-Thasan">Niranjan Kanesa-Thasan</name></noCountry><country name="États-Unis"><region name="Indiana"><name sortKey="Nassim, Cynthia" sort="Nassim, Cynthia" uniqKey="Nassim C" first="Cynthia" last="Nassim">Cynthia Nassim</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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