Immunogenicity of a monovalent, aluminum-adjuvanted influenza whole virus vaccine for pandemic use.
Identifieur interne : 001660 ( Main/Exploration ); précédent : 001659; suivant : 001661Immunogenicity of a monovalent, aluminum-adjuvanted influenza whole virus vaccine for pandemic use.
Auteurs : N. Hehme [Allemagne] ; H. Engelmann ; W. Kuenzel ; E. Neumeier ; R. SaengerSource :
- Virus research [ 0168-1702 ] ; 2004.
Descripteurs français
- KwdFr :
- Adjuvants immunologiques (administration et posologie), Adolescent, Adulte, Aluminium (administration et posologie), Aluminium (immunologie), Anticorps antiviraux (sang), Grippe humaine (), Grippe humaine (immunologie), Humains, Immunoglobuline A (sang), Sialidase (antagonistes et inhibiteurs), Tests d'inhibition de l'hémagglutination, Tests de neutralisation, Vaccins antigrippaux (administration et posologie), Vaccins antigrippaux (immunologie), Virus de la grippe A (immunologie).
- MESH :
- administration et posologie : Adjuvants immunologiques, Aluminium, Vaccins antigrippaux.
- antagonistes et inhibiteurs : Sialidase.
- immunologie : Aluminium, Grippe humaine, Vaccins antigrippaux, Virus de la grippe A.
- sang : Anticorps antiviraux, Immunoglobuline A.
- Adolescent, Adulte, Grippe humaine, Humains, Tests d'inhibition de l'hémagglutination, Tests de neutralisation.
English descriptors
- KwdEn :
- Adjuvants, Immunologic (administration & dosage), Adolescent, Adult, Aluminum (administration & dosage), Aluminum (immunology), Antibodies, Viral (blood), Hemagglutination Inhibition Tests, Humans, Immunoglobulin A (blood), Influenza A virus (immunology), Influenza Vaccines (administration & dosage), Influenza Vaccines (immunology), Influenza, Human (immunology), Influenza, Human (prevention & control), Neuraminidase (antagonists & inhibitors), Neutralization Tests.
- MESH :
- chemical , administration & dosage : Adjuvants, Immunologic, Aluminum, Influenza Vaccines.
- chemical , antagonists & inhibitors : Neuraminidase.
- chemical , blood : Antibodies, Viral, Immunoglobulin A.
- chemical , immunology : Aluminum, Influenza Vaccines.
- immunology : Influenza A virus, Influenza, Human.
- prevention & control : Influenza, Human.
- Adolescent, Adult, Hemagglutination Inhibition Tests, Humans, Neutralization Tests.
Abstract
In the case of an influenza pandemic a significant gap between influenza vaccine manufacturing capacities and vaccine demands must be expected on a global scale. This study explores the possibility to increase the number of vaccine doses that can be provided with the existing resources by using a lower amount of antigen per dose in an aluminum-adjuvanted whole virus vaccine formulation, instead of the standard dosage of 15 microg hemagglutinin (HA). The study was performed as an open, non-controlled, randomized, multicentric study in 200 volunteers (18-30 years of age). Three monovalent aluminum-adjuvanted whole virus formulations with different antigen concentrations (1.9, 3.75 and 7.5 microg HA per dose) were compared to a split virus vaccine (15 microg HA per dose) without aluminum adjuvantation. The sera were tested for hemagglutination inhibition (HI) antibodies, neuraminidase inhibition (NI) antibodies and virus neutralizing (VN) antibodies. Nasal swab samples were tested for influenza-specific IgA antibodies. All volunteers were immunologically naïve to the vaccine strain influenza A/Singapore/1/57 (H2N2). The vaccine was well tolerated. HI titers reached protective levels (geometric mean titer (GMT) >1:40) after two vaccine doses. In the group immunized with the lowest antigen dose the seroprotection rate was 82%. Although the immune response tends to be lower for vaccine formulations with reduced antigen content, the immunogenicity criteria as defined by the European Agency for the Evaluation of Medicinal Products (EMEA) were met with all antigen formulations after two vaccine doses. Significant increases in HI, NI and VN titers were observed, however, no significant local immune response was detected. The use of a low-dose whole virus influenza vaccine, adjuvanted with aluminum appears to be a viable approach to increase vaccine supplies in a pandemic situation.
DOI: 10.1016/j.virusres.2004.02.029
PubMed: 15163505
Affiliations:
Links toward previous steps (curation, corpus...)
- to stream PubMed, to step Corpus: 000331
- to stream PubMed, to step Curation: 000331
- to stream PubMed, to step Checkpoint: 000301
- to stream Ncbi, to step Merge: 000100
- to stream Ncbi, to step Curation: 000100
- to stream Ncbi, to step Checkpoint: 000100
- to stream Main, to step Merge: 001690
- to stream Main, to step Curation: 001660
Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Immunogenicity of a monovalent, aluminum-adjuvanted influenza whole virus vaccine for pandemic use.</title><author><name sortKey="Hehme, N" sort="Hehme, N" uniqKey="Hehme N" first="N" last="Hehme">N. Hehme</name><affiliation wicri:level="3"><nlm:affiliation>GlaxoSmithKline Biologicals, SSW Dresden, Zirkusstrasse 40, D-01069 Dresden, Germany. norbert.w.hehme@gsk.com</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>GlaxoSmithKline Biologicals, SSW Dresden, Zirkusstrasse 40, D-01069 Dresden</wicri:regionArea><placeName><region type="land" nuts="1">Saxe (Land)</region><region type="district" nuts="2">District de Dresde</region><settlement type="city">Dresde</settlement></placeName></affiliation></author><author><name sortKey="Engelmann, H" sort="Engelmann, H" uniqKey="Engelmann H" first="H" last="Engelmann">H. Engelmann</name></author><author><name sortKey="Kuenzel, W" sort="Kuenzel, W" uniqKey="Kuenzel W" first="W" last="Kuenzel">W. Kuenzel</name></author><author><name sortKey="Neumeier, E" sort="Neumeier, E" uniqKey="Neumeier E" first="E" last="Neumeier">E. Neumeier</name></author><author><name sortKey="Saenger, R" sort="Saenger, R" uniqKey="Saenger R" first="R" last="Saenger">R. Saenger</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2004">2004</date><idno type="RBID">pubmed:15163505</idno><idno type="pmid">15163505</idno><idno type="doi">10.1016/j.virusres.2004.02.029</idno><idno type="wicri:Area/PubMed/Corpus">000331</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000331</idno><idno type="wicri:Area/PubMed/Curation">000331</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">000331</idno><idno type="wicri:Area/PubMed/Checkpoint">000301</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">000301</idno><idno type="wicri:Area/Ncbi/Merge">000100</idno><idno type="wicri:Area/Ncbi/Curation">000100</idno><idno type="wicri:Area/Ncbi/Checkpoint">000100</idno><idno type="wicri:doubleKey">0168-1702:2004:Hehme N:immunogenicity:of:a</idno><idno type="wicri:Area/Main/Merge">001690</idno><idno type="wicri:Area/Main/Curation">001660</idno><idno type="wicri:Area/Main/Exploration">001660</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Immunogenicity of a monovalent, aluminum-adjuvanted influenza whole virus vaccine for pandemic use.</title><author><name sortKey="Hehme, N" sort="Hehme, N" uniqKey="Hehme N" first="N" last="Hehme">N. Hehme</name><affiliation wicri:level="3"><nlm:affiliation>GlaxoSmithKline Biologicals, SSW Dresden, Zirkusstrasse 40, D-01069 Dresden, Germany. norbert.w.hehme@gsk.com</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>GlaxoSmithKline Biologicals, SSW Dresden, Zirkusstrasse 40, D-01069 Dresden</wicri:regionArea><placeName><region type="land" nuts="1">Saxe (Land)</region><region type="district" nuts="2">District de Dresde</region><settlement type="city">Dresde</settlement></placeName></affiliation></author><author><name sortKey="Engelmann, H" sort="Engelmann, H" uniqKey="Engelmann H" first="H" last="Engelmann">H. Engelmann</name></author><author><name sortKey="Kuenzel, W" sort="Kuenzel, W" uniqKey="Kuenzel W" first="W" last="Kuenzel">W. Kuenzel</name></author><author><name sortKey="Neumeier, E" sort="Neumeier, E" uniqKey="Neumeier E" first="E" last="Neumeier">E. Neumeier</name></author><author><name sortKey="Saenger, R" sort="Saenger, R" uniqKey="Saenger R" first="R" last="Saenger">R. Saenger</name></author></analytic><series><title level="j">Virus research</title><idno type="ISSN">0168-1702</idno><imprint><date when="2004" type="published">2004</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adjuvants, Immunologic (administration & dosage)</term><term>Adolescent</term><term>Adult</term><term>Aluminum (administration & dosage)</term><term>Aluminum (immunology)</term><term>Antibodies, Viral (blood)</term><term>Hemagglutination Inhibition Tests</term><term>Humans</term><term>Immunoglobulin A (blood)</term><term>Influenza A virus (immunology)</term><term>Influenza Vaccines (administration & dosage)</term><term>Influenza Vaccines (immunology)</term><term>Influenza, Human (immunology)</term><term>Influenza, Human (prevention & control)</term><term>Neuraminidase (antagonists & inhibitors)</term><term>Neutralization Tests</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adjuvants immunologiques (administration et posologie)</term><term>Adolescent</term><term>Adulte</term><term>Aluminium (administration et posologie)</term><term>Aluminium (immunologie)</term><term>Anticorps antiviraux (sang)</term><term>Grippe humaine ()</term><term>Grippe humaine (immunologie)</term><term>Humains</term><term>Immunoglobuline A (sang)</term><term>Sialidase (antagonistes et inhibiteurs)</term><term>Tests d'inhibition de l'hémagglutination</term><term>Tests de neutralisation</term><term>Vaccins antigrippaux (administration et posologie)</term><term>Vaccins antigrippaux (immunologie)</term><term>Virus de la grippe A (immunologie)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Adjuvants, Immunologic</term><term>Aluminum</term><term>Influenza Vaccines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="antagonists & inhibitors" xml:lang="en"><term>Neuraminidase</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Antibodies, Viral</term><term>Immunoglobulin A</term></keywords><keywords scheme="MESH" type="chemical" qualifier="immunology" xml:lang="en"><term>Aluminum</term><term>Influenza Vaccines</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Adjuvants immunologiques</term><term>Aluminium</term><term>Vaccins antigrippaux</term></keywords><keywords scheme="MESH" qualifier="antagonistes et inhibiteurs" xml:lang="fr"><term>Sialidase</term></keywords><keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Aluminium</term><term>Grippe humaine</term><term>Vaccins antigrippaux</term><term>Virus de la grippe A</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Influenza A virus</term><term>Influenza, Human</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Influenza, Human</term></keywords><keywords scheme="MESH" qualifier="sang" xml:lang="fr"><term>Anticorps antiviraux</term><term>Immunoglobuline A</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Hemagglutination Inhibition Tests</term><term>Humans</term><term>Neutralization Tests</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adolescent</term><term>Adulte</term><term>Grippe humaine</term><term>Humains</term><term>Tests d'inhibition de l'hémagglutination</term><term>Tests de neutralisation</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">In the case of an influenza pandemic a significant gap between influenza vaccine manufacturing capacities and vaccine demands must be expected on a global scale. This study explores the possibility to increase the number of vaccine doses that can be provided with the existing resources by using a lower amount of antigen per dose in an aluminum-adjuvanted whole virus vaccine formulation, instead of the standard dosage of 15 microg hemagglutinin (HA). The study was performed as an open, non-controlled, randomized, multicentric study in 200 volunteers (18-30 years of age). Three monovalent aluminum-adjuvanted whole virus formulations with different antigen concentrations (1.9, 3.75 and 7.5 microg HA per dose) were compared to a split virus vaccine (15 microg HA per dose) without aluminum adjuvantation. The sera were tested for hemagglutination inhibition (HI) antibodies, neuraminidase inhibition (NI) antibodies and virus neutralizing (VN) antibodies. Nasal swab samples were tested for influenza-specific IgA antibodies. All volunteers were immunologically naïve to the vaccine strain influenza A/Singapore/1/57 (H2N2). The vaccine was well tolerated. HI titers reached protective levels (geometric mean titer (GMT) >1:40) after two vaccine doses. In the group immunized with the lowest antigen dose the seroprotection rate was 82%. Although the immune response tends to be lower for vaccine formulations with reduced antigen content, the immunogenicity criteria as defined by the European Agency for the Evaluation of Medicinal Products (EMEA) were met with all antigen formulations after two vaccine doses. Significant increases in HI, NI and VN titers were observed, however, no significant local immune response was detected. The use of a low-dose whole virus influenza vaccine, adjuvanted with aluminum appears to be a viable approach to increase vaccine supplies in a pandemic situation.</div></front></TEI><affiliations><list><country><li>Allemagne</li></country><region><li>District de Dresde</li><li>Saxe (Land)</li></region><settlement><li>Dresde</li></settlement></list><tree><noCountry><name sortKey="Engelmann, H" sort="Engelmann, H" uniqKey="Engelmann H" first="H" last="Engelmann">H. Engelmann</name><name sortKey="Kuenzel, W" sort="Kuenzel, W" uniqKey="Kuenzel W" first="W" last="Kuenzel">W. Kuenzel</name><name sortKey="Neumeier, E" sort="Neumeier, E" uniqKey="Neumeier E" first="E" last="Neumeier">E. Neumeier</name><name sortKey="Saenger, R" sort="Saenger, R" uniqKey="Saenger R" first="R" last="Saenger">R. Saenger</name></noCountry><country name="Allemagne"><region name="Saxe (Land)"><name sortKey="Hehme, N" sort="Hehme, N" uniqKey="Hehme N" first="N" last="Hehme">N. Hehme</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Sante/explor/H2N2V1/Data/Main/Exploration
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 001660 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 001660 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Sante
|area= H2N2V1
|flux= Main
|étape= Exploration
|type= RBID
|clé= pubmed:15163505
|texte= Immunogenicity of a monovalent, aluminum-adjuvanted influenza whole virus vaccine for pandemic use.
}}
Pour générer des pages wiki
HfdIndexSelect -h $EXPLOR_AREA/Data/Main/Exploration/RBID.i -Sk "pubmed:15163505" \
| HfdSelect -Kh $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd \
| NlmPubMed2Wicri -a H2N2V1
| This area was generated with Dilib version V0.6.33. |  |