H2N2V1, Main, Exploration, bibRecord, 000691

Phase I/II Randomized Double-Blind Study of the Safety and Immunogenicity of a Nonadjuvanted Vero Cell Culture-Derived Whole-Virus H9N2 Influenza Vaccine in Healthy Adults

Identifieur interne : 000691 ( Main/Exploration ); précédent : 000690; suivant : 000692

Phase I/II Randomized Double-Blind Study of the Safety and Immunogenicity of a Nonadjuvanted Vero Cell Culture-Derived Whole-Virus H9N2 Influenza Vaccine in Healthy Adults

Auteurs : Gerald Aichinger [Autriche] ; Barbara Grohmann-Izay [Autriche] ; Maikel V. W. Van Der Velden [Autriche] ; Sandor Fritsch [Autriche] ; Manuela Koska [Autriche] ; Daniel Portsmouth [Autriche] ; Mary Kate Hart [États-Unis] ; Wael El-Amin [États-Unis] ; Otfried Kistner [Autriche] ; P. Noel Barrett [Autriche]

Source :

Clinical and Vaccine Immunology : CVI [ 1556-6811 ] ; 2014.

RBID : PMC:4278922

Descripteurs français

KwdFr :
- Adolescent, Adulte, Adulte d'âge moyen, Anticorps antiviraux (sang), Anticorps neutralisants (sang), Effets secondaires indésirables des médicaments (anatomopathologie), Effets secondaires indésirables des médicaments (épidémiologie), Femelle, Grippe humaine (), Humains, Immunodiffusion, Jeune adulte, Mâle, Méthode en double aveugle, Résultat thérapeutique, Sous-type H9N2 du virus de la grippe A (immunologie), Tests d'inhibition de l'hémagglutination, Tests de neutralisation, Vaccination (), Vaccination (effets indésirables), Vaccins antigrippaux (administration et posologie), Vaccins antigrippaux (effets indésirables), Vaccins antigrippaux (immunologie), Volontaires sains.
MESH :
- administration et posologie : Vaccins antigrippaux.
- anatomopathologie : Effets secondaires indésirables des médicaments.
- effets indésirables : Vaccination, Vaccins antigrippaux.
- immunologie : Sous-type H9N2 du virus de la grippe A, Vaccins antigrippaux.
- sang : Anticorps antiviraux, Anticorps neutralisants.
- épidémiologie : Effets secondaires indésirables des médicaments.
- Adolescent, Adulte, Adulte d'âge moyen, Femelle, Grippe humaine, Humains, Immunodiffusion, Jeune adulte, Mâle, Méthode en double aveugle, Résultat thérapeutique, Tests d'inhibition de l'hémagglutination, Tests de neutralisation, Vaccination, Volontaires sains.

English descriptors

KwdEn :
- Adolescent, Adult, Antibodies, Neutralizing (blood), Antibodies, Viral (blood), Double-Blind Method, Drug-Related Side Effects and Adverse Reactions (epidemiology), Drug-Related Side Effects and Adverse Reactions (pathology), Female, Healthy Volunteers, Hemagglutination Inhibition Tests, Humans, Immunodiffusion, Influenza A Virus, H9N2 Subtype (immunology), Influenza Vaccines (administration & dosage), Influenza Vaccines (adverse effects), Influenza Vaccines (immunology), Influenza, Human (prevention & control), Male, Middle Aged, Neutralization Tests, Treatment Outcome, Vaccination (adverse effects), Vaccination (methods), Young Adult.
MESH :
- chemical , administration & dosage : Influenza Vaccines.
- chemical , adverse effects : Influenza Vaccines.
- chemical , blood : Antibodies, Neutralizing, Antibodies, Viral.
- adverse effects : Vaccination.
- epidemiology : Drug-Related Side Effects and Adverse Reactions.
- immunology : Influenza A Virus, H9N2 Subtype, Influenza Vaccines.
- methods : Vaccination.
- pathology : Drug-Related Side Effects and Adverse Reactions.
- prevention & control : Influenza, Human.
- Adolescent, Adult, Double-Blind Method, Female, Healthy Volunteers, Hemagglutination Inhibition Tests, Humans, Immunodiffusion, Male, Middle Aged, Neutralization Tests, Treatment Outcome, Young Adult.

Abstract

Studies on candidate pandemic vaccines against avian influenza viruses have focused on H5N1, but viruses of other subtypes, such as A/H9N2, are also considered to have pandemic potential. We investigated the safety and immunogenicity of two immunizations with one of five different antigen doses (ranging from 3.75 to 45 μg of hemagglutinin antigen) of a nonadjuvanted whole-virus G9 lineage H9N2 influenza virus vaccine in healthy adults aged 18 to 49 years. The antibody responses were measured by hemagglutination inhibition (HI), microneutralization (MN), and single radial hemolysis (SRH) assays. To investigate a hypothesis that previous exposure to H2N2 viruses in subjects born in or before 1968 might prime for more robust antibody responses to H9N2 vaccination than that in subjects born after 1968, a post hoc age-stratified analysis of antibody responses was done. Both vaccinations in all dose groups were safe and well tolerated. No vaccine-related serious adverse events were reported, and the majority of the adverse reactions were rated as mild. The rates of injection site reactions were lower in the 3.75-μg- and 7.5-μg-dose groups than those in the higher-dose groups; the rates of systemic reactions were similar across all dose groups. The seroprotection rates among the different dose groups 21 days after the second immunization ranged from 52.8% to 88.9% as measured by HI assay, from 88.7% to 98.1% or 82.7% to 96.2% as measured by MN assay (MN titer cutoffs, 1:40 and 1:80, respectively), and from 94.2% to 100% as measured by SRH assay. Higher antibody responses were not induced in subjects born in or before 1968. These data indicate that a nonadjuvanted whole-virus H9N2 vaccine is well tolerated and immunogenic in healthy adults. (This study has been registered at ClinicalTrials.gov under registration no. NCT01320696.)

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4278922

DOI: 10.1128/CVI.00275-14
PubMed: 25355797
PubMed Central: 4278922

Affiliations:

Le document en format XML

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<term>Adult</term>
<term>Antibodies, Neutralizing (blood)</term>
<term>Antibodies, Viral (blood)</term>
<term>Double-Blind Method</term>
<term>Drug-Related Side Effects and Adverse Reactions (epidemiology)</term>
<term>Drug-Related Side Effects and Adverse Reactions (pathology)</term>
<term>Female</term>
<term>Healthy Volunteers</term>
<term>Hemagglutination Inhibition Tests</term>
<term>Humans</term>
<term>Immunodiffusion</term>
<term>Influenza A Virus, H9N2 Subtype (immunology)</term>
<term>Influenza Vaccines (administration & dosage)</term>
<term>Influenza Vaccines (adverse effects)</term>
<term>Influenza Vaccines (immunology)</term>
<term>Influenza, Human (prevention & control)</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Neutralization Tests</term>
<term>Treatment Outcome</term>
<term>Vaccination (adverse effects)</term>
<term>Vaccination (methods)</term>
<term>Young Adult</term>
</keywords>
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<term>Adulte</term>
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<term>Anticorps antiviraux (sang)</term>
<term>Anticorps neutralisants (sang)</term>
<term>Effets secondaires indésirables des médicaments (anatomopathologie)</term>
<term>Effets secondaires indésirables des médicaments (épidémiologie)</term>
<term>Femelle</term>
<term>Grippe humaine ()</term>
<term>Humains</term>
<term>Immunodiffusion</term>
<term>Jeune adulte</term>
<term>Mâle</term>
<term>Méthode en double aveugle</term>
<term>Résultat thérapeutique</term>
<term>Sous-type H9N2 du virus de la grippe A (immunologie)</term>
<term>Tests d'inhibition de l'hémagglutination</term>
<term>Tests de neutralisation</term>
<term>Vaccination ()</term>
<term>Vaccination (effets indésirables)</term>
<term>Vaccins antigrippaux (administration et posologie)</term>
<term>Vaccins antigrippaux (effets indésirables)</term>
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</keywords>
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</keywords>
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<term>Antibodies, Viral</term>
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</keywords>
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<term>Vaccins antigrippaux</term>
</keywords>
<keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Drug-Related Side Effects and Adverse Reactions</term>
</keywords>
<keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Sous-type H9N2 du virus de la grippe A</term>
<term>Vaccins antigrippaux</term>
</keywords>
<keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Influenza A Virus, H9N2 Subtype</term>
<term>Influenza Vaccines</term>
</keywords>
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</keywords>
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</keywords>
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</keywords>
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<term>Anticorps neutralisants</term>
</keywords>
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</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adolescent</term>
<term>Adult</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Healthy Volunteers</term>
<term>Hemagglutination Inhibition Tests</term>
<term>Humans</term>
<term>Immunodiffusion</term>
<term>Male</term>
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<term>Neutralization Tests</term>
<term>Treatment Outcome</term>
<term>Young Adult</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adolescent</term>
<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Femelle</term>
<term>Grippe humaine</term>
<term>Humains</term>
<term>Immunodiffusion</term>
<term>Jeune adulte</term>
<term>Mâle</term>
<term>Méthode en double aveugle</term>
<term>Résultat thérapeutique</term>
<term>Tests d'inhibition de l'hémagglutination</term>
<term>Tests de neutralisation</term>
<term>Vaccination</term>
<term>Volontaires sains</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><p>Studies on candidate pandemic vaccines against avian influenza viruses have focused on H5N1, but viruses of other subtypes, such as A/H9N2, are also considered to have pandemic potential. We investigated the safety and immunogenicity of two immunizations with one of five different antigen doses (ranging from 3.75 to 45 μg of hemagglutinin antigen) of a nonadjuvanted whole-virus G9 lineage H9N2 influenza virus vaccine in healthy adults aged 18 to 49 years. The antibody responses were measured by hemagglutination inhibition (HI), microneutralization (MN), and single radial hemolysis (SRH) assays. To investigate a hypothesis that previous exposure to H2N2 viruses in subjects born in or before 1968 might prime for more robust antibody responses to H9N2 vaccination than that in subjects born after 1968, a <italic>post hoc</italic>
 age-stratified analysis of antibody responses was done. Both vaccinations in all dose groups were safe and well tolerated. No vaccine-related serious adverse events were reported, and the majority of the adverse reactions were rated as mild. The rates of injection site reactions were lower in the 3.75-μg- and 7.5-μg-dose groups than those in the higher-dose groups; the rates of systemic reactions were similar across all dose groups. The seroprotection rates among the different dose groups 21 days after the second immunization ranged from 52.8% to 88.9% as measured by HI assay, from 88.7% to 98.1% or 82.7% to 96.2% as measured by MN assay (MN titer cutoffs, 1:40 and 1:80, respectively), and from 94.2% to 100% as measured by SRH assay. Higher antibody responses were not induced in subjects born in or before 1968. These data indicate that a nonadjuvanted whole-virus H9N2 vaccine is well tolerated and immunogenic in healthy adults. (This study has been registered at <ext-link ext-link-type="uri" xlink:href="http://ClinicalTrials.gov">ClinicalTrials.gov</ext-link>
 under registration no. NCT01320696.)</p>
</div>
</front>
</TEI>
<affiliations><list><country><li>Autriche</li>
<li>États-Unis</li>
</country>
<region><li>Maryland</li>
<li>Vienne (Autriche)</li>
</region>
<settlement><li>Vienne (Autriche)</li>
</settlement>
</list>
<tree><country name="Autriche"><region name="Vienne (Autriche)"><name sortKey="Aichinger, Gerald" sort="Aichinger, Gerald" uniqKey="Aichinger G" first="Gerald" last="Aichinger">Gerald Aichinger</name>
</region>
<name sortKey="Barrett, P Noel" sort="Barrett, P Noel" uniqKey="Barrett P" first="P. Noel" last="Barrett">P. Noel Barrett</name>
<name sortKey="Fritsch, Sandor" sort="Fritsch, Sandor" uniqKey="Fritsch S" first="Sandor" last="Fritsch">Sandor Fritsch</name>
<name sortKey="Grohmann Izay, Barbara" sort="Grohmann Izay, Barbara" uniqKey="Grohmann Izay B" first="Barbara" last="Grohmann-Izay">Barbara Grohmann-Izay</name>
<name sortKey="Kistner, Otfried" sort="Kistner, Otfried" uniqKey="Kistner O" first="Otfried" last="Kistner">Otfried Kistner</name>
<name sortKey="Koska, Manuela" sort="Koska, Manuela" uniqKey="Koska M" first="Manuela" last="Koska">Manuela Koska</name>
<name sortKey="Portsmouth, Daniel" sort="Portsmouth, Daniel" uniqKey="Portsmouth D" first="Daniel" last="Portsmouth">Daniel Portsmouth</name>
<name sortKey="Van Der Velden, Maikel V W" sort="Van Der Velden, Maikel V W" uniqKey="Van Der Velden M" first="Maikel V. W." last="Van Der Velden">Maikel V. W. Van Der Velden</name>
</country>
<country name="États-Unis"><region name="Maryland"><name sortKey="Hart, Mary Kate" sort="Hart, Mary Kate" uniqKey="Hart M" first="Mary Kate" last="Hart">Mary Kate Hart</name>
</region>
<name sortKey="El Amin, Wael" sort="El Amin, Wael" uniqKey="El Amin W" first="Wael" last="El-Amin">Wael El-Amin</name>
</country>
</tree>
</affiliations>
</record>

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Phase I/II Randomized Double-Blind Study of the Safety and Immunogenicity of a Nonadjuvanted Vero Cell Culture-Derived Whole-Virus H9N2 Influenza Vaccine in Healthy Adults

Phase I/II Randomized Double-Blind Study of the Safety and Immunogenicity of a Nonadjuvanted Vero Cell Culture-Derived Whole-Virus H9N2 Influenza Vaccine in Healthy Adults

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