An open‐label phase I trial of a live attenuated H2N2 influenza virus vaccine in healthy adults
Identifieur interne : 000A85 ( Main/Exploration ); précédent : 000A84; suivant : 000A86An open‐label phase I trial of a live attenuated H2N2 influenza virus vaccine in healthy adults
Auteurs : Kawsar R. Talaat ; Ruth A. Karron ; Philana H. Liang ; Bridget A. Mcmahon ; Catherine J. Luke ; Bhagvanji Thumar ; Grace L. Chen ; Ji-Young Min ; Elaine W. Lamirande ; Hong Jin ; Kathy L. Coelingh ; George W. Kemble ; Kanta SubbaraoSource :
- Influenza and Other Respiratory Viruses [ 1750-2640 ] ; 2012.
Descripteurs français
- KwdFr :
- Adulte, Anticorps antiviraux (sang), Excrétion virale, Femelle, Grippe humaine (), Grippe humaine (immunologie), Grippe humaine (virologie), Humains, Jeune adulte, Mâle, Réplication virale, Résultat thérapeutique, Sous-type H2N2 du virus de la grippe A (génétique), Sous-type H2N2 du virus de la grippe A (immunologie), Sous-type H2N2 du virus de la grippe A (isolement et purification), Sous-type H2N2 du virus de la grippe A (physiologie), Vaccination, Vaccins antigrippaux (administration et posologie), Vaccins antigrippaux (effets indésirables), Vaccins antigrippaux (immunologie), Vaccins atténués (administration et posologie), Vaccins atténués (effets indésirables), Vaccins atténués (immunologie).
- MESH :
- administration et posologie : Vaccins antigrippaux, Vaccins atténués.
- effets indésirables : Vaccins antigrippaux, Vaccins atténués.
- génétique : Sous-type H2N2 du virus de la grippe A.
- immunologie : Grippe humaine, Sous-type H2N2 du virus de la grippe A, Vaccins antigrippaux, Vaccins atténués.
- isolement et purification : Sous-type H2N2 du virus de la grippe A.
- physiologie : Sous-type H2N2 du virus de la grippe A.
- sang : Anticorps antiviraux.
- virologie : Grippe humaine.
- Adulte, Excrétion virale, Femelle, Grippe humaine, Humains, Jeune adulte, Mâle, Réplication virale, Résultat thérapeutique, Vaccination.
English descriptors
- KwdEn :
- Adult, Antibodies, Viral (blood), Female, Humans, Influenza A Virus, H2N2 Subtype (genetics), Influenza A Virus, H2N2 Subtype (immunology), Influenza A Virus, H2N2 Subtype (isolation & purification), Influenza A Virus, H2N2 Subtype (physiology), Influenza Vaccines (administration & dosage), Influenza Vaccines (adverse effects), Influenza Vaccines (immunology), Influenza, Human (immunology), Influenza, Human (prevention & control), Influenza, Human (virology), Male, Treatment Outcome, Vaccination, Vaccines, Attenuated (administration & dosage), Vaccines, Attenuated (adverse effects), Vaccines, Attenuated (immunology), Virus Replication, Virus Shedding, Young Adult.
- MESH :
- chemical , administration & dosage : Influenza Vaccines, Vaccines, Attenuated.
- chemical , adverse effects : Influenza Vaccines, Vaccines, Attenuated.
- chemical , blood : Antibodies, Viral.
- genetics : Influenza A Virus, H2N2 Subtype.
- immunology : Influenza A Virus, H2N2 Subtype, Influenza Vaccines, Influenza, Human, Vaccines, Attenuated.
- isolation & purification : Influenza A Virus, H2N2 Subtype.
- physiology : Influenza A Virus, H2N2 Subtype.
- prevention & control : Influenza, Human.
- virology : Influenza, Human.
- Adult, Female, Humans, Male, Treatment Outcome, Vaccination, Virus Replication, Virus Shedding, Young Adult.
Abstract
Url:
DOI: 10.1111/j.1750-2659.2012.00350.x
PubMed: 22417012
PubMed Central: 3527634
Affiliations:
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Le document en format XML
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Talaat</name><affiliation><nlm:aff id="a1"></nlm:aff></affiliation></author><author><name sortKey="Karron, Ruth A" sort="Karron, Ruth A" uniqKey="Karron R" first="Ruth A." last="Karron">Ruth A. Karron</name><affiliation><nlm:aff id="a1"></nlm:aff></affiliation></author><author><name sortKey="Liang, Philana H" sort="Liang, Philana H" uniqKey="Liang P" first="Philana H." last="Liang">Philana H. Liang</name><affiliation><nlm:aff id="a1"></nlm:aff></affiliation></author><author><name sortKey="Mcmahon, Bridget A" sort="Mcmahon, Bridget A" uniqKey="Mcmahon B" first="Bridget A." last="Mcmahon">Bridget A. Mcmahon</name><affiliation><nlm:aff id="a1"></nlm:aff></affiliation></author><author><name sortKey="Luke, Catherine J" sort="Luke, Catherine J" uniqKey="Luke C" first="Catherine J." last="Luke">Catherine J. Luke</name><affiliation><nlm:aff id="a2"></nlm:aff></affiliation></author><author><name sortKey="Thumar, Bhagvanji" sort="Thumar, Bhagvanji" uniqKey="Thumar B" first="Bhagvanji" last="Thumar">Bhagvanji Thumar</name><affiliation><nlm:aff id="a1"></nlm:aff></affiliation></author><author><name sortKey="Chen, Grace L" sort="Chen, Grace L" uniqKey="Chen G" first="Grace L." last="Chen">Grace L. Chen</name><affiliation><nlm:aff id="a2"></nlm:aff></affiliation></author><author><name sortKey="Min, Ji Oung" sort="Min, Ji Oung" uniqKey="Min J" first="Ji-Young" last="Min">Ji-Young Min</name><affiliation><nlm:aff id="a2"></nlm:aff></affiliation></author><author><name sortKey="Lamirande, Elaine W" sort="Lamirande, Elaine W" uniqKey="Lamirande E" first="Elaine W." last="Lamirande">Elaine W. Lamirande</name><affiliation><nlm:aff id="a2"></nlm:aff></affiliation></author><author><name sortKey="Jin, Hong" sort="Jin, Hong" uniqKey="Jin H" first="Hong" last="Jin">Hong Jin</name><affiliation><nlm:aff id="a3"></nlm:aff></affiliation></author><author><name sortKey="Coelingh, Kathy L" sort="Coelingh, Kathy L" uniqKey="Coelingh K" first="Kathy L." last="Coelingh">Kathy L. Coelingh</name><affiliation><nlm:aff id="a3"></nlm:aff></affiliation></author><author><name sortKey="Kemble, George W" sort="Kemble, George W" uniqKey="Kemble G" first="George W." last="Kemble">George W. Kemble</name><affiliation><nlm:aff id="a3"></nlm:aff></affiliation></author><author><name sortKey="Subbarao, Kanta" sort="Subbarao, Kanta" uniqKey="Subbarao K" first="Kanta" last="Subbarao">Kanta Subbarao</name><affiliation><nlm:aff id="a2"></nlm:aff></affiliation></author></analytic><series><title level="j">Influenza and Other Respiratory Viruses</title><idno type="ISSN">1750-2640</idno><idno type="eISSN">1750-2659</idno><imprint><date when="2012">2012</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Antibodies, Viral (blood)</term><term>Female</term><term>Humans</term><term>Influenza A Virus, H2N2 Subtype (genetics)</term><term>Influenza A Virus, H2N2 Subtype (immunology)</term><term>Influenza A Virus, H2N2 Subtype (isolation & purification)</term><term>Influenza A Virus, H2N2 Subtype (physiology)</term><term>Influenza Vaccines (administration & dosage)</term><term>Influenza Vaccines (adverse effects)</term><term>Influenza Vaccines (immunology)</term><term>Influenza, Human (immunology)</term><term>Influenza, Human (prevention & control)</term><term>Influenza, Human (virology)</term><term>Male</term><term>Treatment Outcome</term><term>Vaccination</term><term>Vaccines, Attenuated (administration & dosage)</term><term>Vaccines, Attenuated (adverse effects)</term><term>Vaccines, Attenuated (immunology)</term><term>Virus Replication</term><term>Virus Shedding</term><term>Young Adult</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term><term>Anticorps antiviraux (sang)</term><term>Excrétion virale</term><term>Femelle</term><term>Grippe humaine ()</term><term>Grippe humaine (immunologie)</term><term>Grippe humaine (virologie)</term><term>Humains</term><term>Jeune adulte</term><term>Mâle</term><term>Réplication virale</term><term>Résultat thérapeutique</term><term>Sous-type H2N2 du virus de la grippe A (génétique)</term><term>Sous-type H2N2 du virus de la grippe A (immunologie)</term><term>Sous-type H2N2 du virus de la grippe A (isolement et purification)</term><term>Sous-type H2N2 du virus de la grippe A (physiologie)</term><term>Vaccination</term><term>Vaccins antigrippaux (administration et posologie)</term><term>Vaccins antigrippaux (effets indésirables)</term><term>Vaccins antigrippaux (immunologie)</term><term>Vaccins atténués (administration et posologie)</term><term>Vaccins atténués (effets indésirables)</term><term>Vaccins atténués (immunologie)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Influenza Vaccines</term><term>Vaccines, Attenuated</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Influenza Vaccines</term><term>Vaccines, Attenuated</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Antibodies, Viral</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Vaccins antigrippaux</term><term>Vaccins atténués</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Vaccins antigrippaux</term><term>Vaccins atténués</term></keywords><keywords scheme="MESH" qualifier="genetics" xml:lang="en"><term>Influenza A Virus, H2N2 Subtype</term></keywords><keywords scheme="MESH" qualifier="génétique" xml:lang="fr"><term>Sous-type H2N2 du virus de la grippe A</term></keywords><keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Grippe humaine</term><term>Sous-type H2N2 du virus de la grippe A</term><term>Vaccins antigrippaux</term><term>Vaccins atténués</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Influenza A Virus, H2N2 Subtype</term><term>Influenza Vaccines</term><term>Influenza, Human</term><term>Vaccines, Attenuated</term></keywords><keywords scheme="MESH" qualifier="isolation & purification" xml:lang="en"><term>Influenza A Virus, H2N2 Subtype</term></keywords><keywords scheme="MESH" qualifier="isolement et purification" xml:lang="fr"><term>Sous-type H2N2 du virus de la grippe A</term></keywords><keywords scheme="MESH" qualifier="physiologie" xml:lang="fr"><term>Sous-type H2N2 du virus de la grippe A</term></keywords><keywords scheme="MESH" qualifier="physiology" xml:lang="en"><term>Influenza A Virus, H2N2 Subtype</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></keywords><keywords scheme="MESH" qualifier="virologie" xml:lang="fr"><term>Grippe humaine</term></keywords><keywords scheme="MESH" qualifier="virology" xml:lang="en"><term>Influenza, Human</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Female</term><term>Humans</term><term>Male</term><term>Treatment Outcome</term><term>Vaccination</term><term>Virus Replication</term><term>Virus Shedding</term><term>Young Adult</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Excrétion virale</term><term>Femelle</term><term>Grippe humaine</term><term>Humains</term><term>Jeune adulte</term><term>Mâle</term><term>Réplication virale</term><term>Résultat thérapeutique</term><term>Vaccination</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><italic>Please cite this paper as:</italic> Talaat <italic>et al.</italic> (2012) An open‐label phase I trial of a live attenuated H2N2 influenza virus vaccine in healthy adults. Influenza and Other Respiratory Viruses DOI: 10.1111/j.1750‐2659.2012.00350.x.</p><p><bold>Background </bold> Live attenuated influenza vaccines (LAIV) against a variety of strains of pandemic potential are being developed and tested. We describe the results of an open‐label phase I trial of a live attenuated H2N2 virus vaccine.</p><p><bold>Objectives </bold> To evaluate the safety, infectivity, and immunogenicity of a live attenuated H2N2 influenza virus vaccine.</p><p><bold>Participants/methods </bold> The A/Ann Arbor/6/60 (H2N2) virus used in this study is the attenuated, cold‐adapted, temperature‐sensitive strain that provides the genetic backbone of seasonal LAIV (MedImmune). We evaluated the safety, infectivity, and immunogenicity of two doses of 10<sup>7</sup> TCID<sub>50</sub> of this vaccine administered by nasal spray 4 weeks apart to normal healthy seronegative adults.</p><p><bold>Results </bold> Twenty‐one participants received a first dose of the vaccine; 18 participants received a second dose. No serious adverse events occurred during the trial. The most common adverse events after vaccination were headache and musculoskeletal pain. The vaccine was restricted in replication: 24% and 17% had virus detectable by culture or rRT‐PCR after the first and second dose, respectively. Antibody responses to the vaccine were also restricted: 24% of participants developed an antibody response as measured by either hemagglutination‐inhibition assay (10%), or ELISA for H2 HA‐specific serum IgG (24%) or IgA (16%) after either one or two doses. None of the participants had a neutralizing antibody response. Vaccine‐specific IgG‐secreting cells as measured by enzyme‐linked immunospot increased from a mean of 0·5 to 2·0/10<sup>6</sup> peripheral blood mononuclear cells (PBMCs); vaccine‐specific IgA‐secreting cells increased from 0·1 to 0·5/10<sup>6</sup> PBMCs.</p><p><bold>Conclusions </bold> The live attenuated H2N2 1960 AA <italic>ca</italic> vaccine demonstrated a safety profile consistent with seasonal trivalent LAIV but was restricted in replication and minimally immunogenic in healthy seronegative adults.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI><affiliations><list></list><tree><noCountry><name sortKey="Chen, Grace L" sort="Chen, Grace L" uniqKey="Chen G" first="Grace L." last="Chen">Grace L. Chen</name><name sortKey="Coelingh, Kathy L" sort="Coelingh, Kathy L" uniqKey="Coelingh K" first="Kathy L." last="Coelingh">Kathy L. Coelingh</name><name sortKey="Jin, Hong" sort="Jin, Hong" uniqKey="Jin H" first="Hong" last="Jin">Hong Jin</name><name sortKey="Karron, Ruth A" sort="Karron, Ruth A" uniqKey="Karron R" first="Ruth A." last="Karron">Ruth A. Karron</name><name sortKey="Kemble, George W" sort="Kemble, George W" uniqKey="Kemble G" first="George W." last="Kemble">George W. Kemble</name><name sortKey="Lamirande, Elaine W" sort="Lamirande, Elaine W" uniqKey="Lamirande E" first="Elaine W." last="Lamirande">Elaine W. Lamirande</name><name sortKey="Liang, Philana H" sort="Liang, Philana H" uniqKey="Liang P" first="Philana H." last="Liang">Philana H. Liang</name><name sortKey="Luke, Catherine J" sort="Luke, Catherine J" uniqKey="Luke C" first="Catherine J." last="Luke">Catherine J. Luke</name><name sortKey="Mcmahon, Bridget A" sort="Mcmahon, Bridget A" uniqKey="Mcmahon B" first="Bridget A." last="Mcmahon">Bridget A. Mcmahon</name><name sortKey="Min, Ji Oung" sort="Min, Ji Oung" uniqKey="Min J" first="Ji-Young" last="Min">Ji-Young Min</name><name sortKey="Subbarao, Kanta" sort="Subbarao, Kanta" uniqKey="Subbarao K" first="Kanta" last="Subbarao">Kanta Subbarao</name><name sortKey="Talaat, Kawsar R" sort="Talaat, Kawsar R" uniqKey="Talaat K" first="Kawsar R." last="Talaat">Kawsar R. Talaat</name><name sortKey="Thumar, Bhagvanji" sort="Thumar, Bhagvanji" uniqKey="Thumar B" first="Bhagvanji" last="Thumar">Bhagvanji Thumar</name></noCountry></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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