A dose-ranging study of MF59(®)-adjuvanted and non-adjuvanted A/H1N1 pandemic influenza vaccine in young to middle-aged and older adult populations to assess safety, immunogenicity, and antibody persistence one year after vaccination.
Identifieur interne : 000856 ( PubMed/Checkpoint ); précédent : 000855; suivant : 000857A dose-ranging study of MF59(®)-adjuvanted and non-adjuvanted A/H1N1 pandemic influenza vaccine in young to middle-aged and older adult populations to assess safety, immunogenicity, and antibody persistence one year after vaccination.
Auteurs : Keith S. Reisinger [États-Unis] ; Sandra J. Holmes ; Paola Pedotti ; Ashwani Kumar Arora ; Maria LattanziSource :
- Human vaccines & immunotherapeutics [ 2164-554X ] ; 2014.
Descripteurs français
- KwdFr :
- Adjuvants immunologiques (administration et posologie), Adjuvants immunologiques (effets indésirables), Adolescent, Adulte, Adulte d'âge moyen, Anticorps antiviraux (sang), Femelle, Grippe humaine (), Grippe humaine (virologie), Humains, Jeune adulte, Mâle, Polysorbates (administration et posologie), Polysorbates (effets indésirables), Sous-type H1N1 du virus de la grippe A (immunologie), Squalène (administration et posologie), Squalène (effets indésirables), Sujet âgé, Sujet âgé de 80 ans ou plus, Tests d'inhibition de l'hémagglutination, Vaccins antigrippaux (administration et posologie), Vaccins antigrippaux (effets indésirables), Vaccins antigrippaux (immunologie), Volontaires sains.
- MESH :
- administration et posologie : Adjuvants immunologiques, Polysorbates, Squalène, Vaccins antigrippaux.
- effets indésirables : Adjuvants immunologiques, Polysorbates, Squalène, Vaccins antigrippaux.
- immunologie : Sous-type H1N1 du virus de la grippe A, Vaccins antigrippaux.
- sang : Anticorps antiviraux.
- virologie : Grippe humaine.
- Adolescent, Adulte, Adulte d'âge moyen, Femelle, Grippe humaine, Humains, Jeune adulte, Mâle, Sujet âgé, Sujet âgé de 80 ans ou plus, Tests d'inhibition de l'hémagglutination, Volontaires sains.
English descriptors
- KwdEn :
- Adjuvants, Immunologic (administration & dosage), Adjuvants, Immunologic (adverse effects), Adolescent, Adult, Aged, Aged, 80 and over, Antibodies, Viral (blood), Female, Healthy Volunteers, Hemagglutination Inhibition Tests, Humans, Influenza A Virus, H1N1 Subtype (immunology), Influenza Vaccines (administration & dosage), Influenza Vaccines (adverse effects), Influenza Vaccines (immunology), Influenza, Human (prevention & control), Influenza, Human (virology), Male, Middle Aged, Polysorbates (administration & dosage), Polysorbates (adverse effects), Squalene (administration & dosage), Squalene (adverse effects), Young Adult.
- MESH :
- chemical , administration & dosage : Adjuvants, Immunologic, Influenza Vaccines, Polysorbates, Squalene.
- chemical , adverse effects : Adjuvants, Immunologic, Influenza Vaccines, Polysorbates, Squalene.
- chemical , blood : Antibodies, Viral.
- immunology : Influenza A Virus, H1N1 Subtype, Influenza Vaccines.
- prevention & control : Influenza, Human.
- virology : Influenza, Human.
- Adolescent, Adult, Aged, Aged, 80 and over, Female, Healthy Volunteers, Hemagglutination Inhibition Tests, Humans, Male, Middle Aged, Young Adult.
Abstract
During development of an A/H1N1 pandemic influenza vaccine, this study was performed to identify the antigen and adjuvant content which would provide optimal antibody response and persistence in adults and the elderly. Dose-sparing strategies, such as inclusion of adjuvants, are critical in ensuring the widest possible population coverage in the event of an influenza pandemic, despite a limited global capacity for vaccine manufacture.
DOI: 10.4161/hv.29393
PubMed: 25424947
Affiliations:
Links toward previous steps (curation, corpus...)
Links to Exploration step
pubmed:25424947Le document en format XML
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<term>Healthy Volunteers</term>
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<front><div type="abstract" xml:lang="en">During development of an A/H1N1 pandemic influenza vaccine, this study was performed to identify the antigen and adjuvant content which would provide optimal antibody response and persistence in adults and the elderly. Dose-sparing strategies, such as inclusion of adjuvants, are critical in ensuring the widest possible population coverage in the event of an influenza pandemic, despite a limited global capacity for vaccine manufacture.</div>
</front>
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<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">25424947</PMID>
<DateCompleted><Year>2015</Year>
<Month>07</Month>
<Day>10</Day>
</DateCompleted>
<DateRevised><Year>2018</Year>
<Month>11</Month>
<Day>13</Day>
</DateRevised>
<Article PubModel="Print"><Journal><ISSN IssnType="Electronic">2164-554X</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>10</Volume>
<Issue>8</Issue>
<PubDate><Year>2014</Year>
</PubDate>
</JournalIssue>
<Title>Human vaccines & immunotherapeutics</Title>
<ISOAbbreviation>Hum Vaccin Immunother</ISOAbbreviation>
</Journal>
<ArticleTitle>A dose-ranging study of MF59(®)-adjuvanted and non-adjuvanted A/H1N1 pandemic influenza vaccine in young to middle-aged and older adult populations to assess safety, immunogenicity, and antibody persistence one year after vaccination.</ArticleTitle>
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<Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">During development of an A/H1N1 pandemic influenza vaccine, this study was performed to identify the antigen and adjuvant content which would provide optimal antibody response and persistence in adults and the elderly. Dose-sparing strategies, such as inclusion of adjuvants, are critical in ensuring the widest possible population coverage in the event of an influenza pandemic, despite a limited global capacity for vaccine manufacture.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">Healthy subjects aged 18-64 years (n = 1240) and ≥65 years (n = 1352) were vaccinated with 1 of 8 investigational vaccine formulations varying in antigen quantity (3.75 µg to 30 µg of hemagglutinin) and MF59(®) adjuvant (none, half dose, or full dose). All subjects received 2 vaccine doses administered 3 weeks apart. Antibody response was assessed by hemagglutination inhibition assay 1 and 3 weeks after administration of first and second doses. Antibody persistence was assessed after 6 and 12 mo. Vaccine safety was monitored over 12 mo.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">All 8 investigational A/H1N1 vaccine formulations were well tolerated, and rapidly induced high antibody titers which met all of the Center for Biologics Evaluation and Research (CBER) and Committee for Medicinal Products for Human Use (CHMP) licensure criteria 3 weeks after one dose. The highest antibody titers were observed in participants vaccinated with higher quantities of antigen and adjuvant.</AbstractText>
<AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">A single vaccine dose containing 3.75 µg of A/California/7/2009 (H1N1) antigen with MF59 adjuvant was identified as optimal for young to middle-aged (18-64 years) and older (≥65 years) adult populations.</AbstractText>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Reisinger</LastName>
<ForeName>Keith S</ForeName>
<Initials>KS</Initials>
<AffiliationInfo><Affiliation>a Primary Physicians Research, Medicine; Pittsburgh, PA USA.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Holmes</LastName>
<ForeName>Sandra J</ForeName>
<Initials>SJ</Initials>
</Author>
<Author ValidYN="Y"><LastName>Pedotti</LastName>
<ForeName>Paola</ForeName>
<Initials>P</Initials>
</Author>
<Author ValidYN="Y"><LastName>Arora</LastName>
<ForeName>Ashwani Kumar</ForeName>
<Initials>AK</Initials>
</Author>
<Author ValidYN="Y"><LastName>Lattanzi</LastName>
<ForeName>Maria</ForeName>
<Initials>M</Initials>
</Author>
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<Language>eng</Language>
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<Country>United States</Country>
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<MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName>
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<MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName>
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<MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D011136" MajorTopicYN="N">Polysorbates</DescriptorName>
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<QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName>
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