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 : 000F00 ( Main/Exploration ); précédent : 000E99; suivant : 000F01A 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 [États-Unis] ; Paola Pedotti [États-Unis] ; Ashwani Kumar Arora [États-Unis] ; Maria Lattanzi [États-Unis]Source :
- Human Vaccines & Immunotherapeutics [ 2164-5515 ] ; 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
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.
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.
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.
Conclusion
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.
Url:
DOI: 10.4161/hv.29393
PubMed: 25424947
PubMed Central: 4896790
Affiliations:
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Le document en format XML
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Reisinger</name><affiliation wicri:level="2"><nlm:aff id="A1">Primary Physicians Research, Medicine; Pittsburgh, PA USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName><wicri:cityArea>Primary Physicians Research, Medicine; Pittsburgh</wicri:cityArea></affiliation></author><author><name sortKey="Holmes, Sandra J" sort="Holmes, Sandra J" uniqKey="Holmes S" first="Sandra J" last="Holmes">Sandra J. Holmes</name><affiliation wicri:level="2"><nlm:aff id="A2">Novartis Vaccines and Diagnostics Inc.; Cambridge, MA USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Novartis Vaccines and Diagnostics Inc.; Cambridge</wicri:cityArea></affiliation></author><author><name sortKey="Pedotti, Paola" sort="Pedotti, Paola" uniqKey="Pedotti P" first="Paola" last="Pedotti">Paola Pedotti</name><affiliation wicri:level="2"><nlm:aff id="A2">Novartis Vaccines and Diagnostics Inc.; Cambridge, MA USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Novartis Vaccines and Diagnostics Inc.; Cambridge</wicri:cityArea></affiliation></author><author><name sortKey="Arora, Ashwani Kumar" sort="Arora, Ashwani Kumar" uniqKey="Arora A" first="Ashwani Kumar" last="Arora">Ashwani Kumar Arora</name><affiliation wicri:level="2"><nlm:aff id="A2">Novartis Vaccines and Diagnostics 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(administration et posologie)</term><term>Adjuvants immunologiques (effets indésirables)</term><term>Adolescent</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Anticorps antiviraux (sang)</term><term>Femelle</term><term>Grippe humaine ()</term><term>Grippe humaine (virologie)</term><term>Humains</term><term>Jeune adulte</term><term>Mâle</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>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Tests d'inhibition de l'hémagglutination</term><term>Vaccins antigrippaux (administration et posologie)</term><term>Vaccins antigrippaux (effets indésirables)</term><term>Vaccins antigrippaux (immunologie)</term><term>Volontaires sains</term></keywords><keywords scheme="MESH" type="chemical" 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</p><p>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.</p><p>Methods</p><p>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<sup>®</sup> 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.</p><p>Results</p><p>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.</p><p>Conclusion</p><p>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.</p></div></front></TEI><affiliations><list><country><li>États-Unis</li></country><region><li>Massachusetts</li><li>Pennsylvanie</li></region></list><tree><country name="États-Unis"><region name="Pennsylvanie"><name sortKey="Reisinger, Keith S" sort="Reisinger, Keith S" uniqKey="Reisinger K" first="Keith S" last="Reisinger">Keith S. Reisinger</name></region><name sortKey="Arora, Ashwani Kumar" sort="Arora, Ashwani Kumar" uniqKey="Arora A" first="Ashwani Kumar" last="Arora">Ashwani Kumar Arora</name><name sortKey="Holmes, Sandra J" sort="Holmes, Sandra J" uniqKey="Holmes S" first="Sandra J" last="Holmes">Sandra J. Holmes</name><name sortKey="Lattanzi, Maria" sort="Lattanzi, Maria" uniqKey="Lattanzi M" first="Maria" last="Lattanzi">Maria Lattanzi</name><name sortKey="Pedotti, Paola" sort="Pedotti, Paola" uniqKey="Pedotti P" first="Paola" last="Pedotti">Paola Pedotti</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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