An open‐label phase I trial of a live attenuated H2N2 influenza virus vaccine in healthy adults
Identifieur interne : 000751 ( Pmc/Checkpoint ); précédent : 000750; suivant : 000752An 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.
Abstract
Url:
DOI: 10.1111/j.1750-2659.2012.00350.x
PubMed: 22417012
PubMed Central: 3527634
Affiliations:
Links toward previous steps (curation, corpus...)
Links to Exploration step
PMC:3527634Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">An open‐label phase I trial of a live attenuated H2N2 influenza virus vaccine in healthy adults</title><author><name sortKey="Talaat, Kawsar R" sort="Talaat, Kawsar R" uniqKey="Talaat K" first="Kawsar R." last="Talaat">Kawsar R. 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></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">22417012</idno><idno type="pmc">3527634</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3527634</idno><idno type="RBID">PMC:3527634</idno><idno type="doi">10.1111/j.1750-2659.2012.00350.x</idno><date when="2012">2012</date><idno type="wicri:Area/Pmc/Corpus">000977</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000977</idno><idno type="wicri:Area/Pmc/Curation">000977</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000977</idno><idno type="wicri:Area/Pmc/Checkpoint">000751</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">000751</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">An open‐label phase I trial of a live attenuated H2N2 influenza virus vaccine in healthy adults</title><author><name sortKey="Talaat, Kawsar R" sort="Talaat, Kawsar R" uniqKey="Talaat K" first="Kawsar R." last="Talaat">Kawsar R. 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></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><pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Influenza Other Respir Viruses</journal-id><journal-id journal-id-type="iso-abbrev">Influenza Other Respir Viruses</journal-id><journal-id journal-id-type="doi">10.1111/(ISSN)1750-2659</journal-id><journal-id journal-id-type="publisher-id">IRV</journal-id><journal-title-group><journal-title>Influenza and Other Respiratory Viruses</journal-title></journal-title-group><issn pub-type="ppub">1750-2640</issn><issn pub-type="epub">1750-2659</issn><publisher><publisher-name>Blackwell Publishing Ltd</publisher-name><publisher-loc>Oxford, UK</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">22417012</article-id><article-id pub-id-type="pmc">3527634</article-id><article-id pub-id-type="doi">10.1111/j.1750-2659.2012.00350.x</article-id><article-id pub-id-type="publisher-id">IRV350</article-id><article-categories><subj-group subj-group-type="heading"><subject>Original Articles</subject></subj-group><subj-group subj-group-type="overline"><subject>Original Article</subject></subj-group></article-categories><title-group><article-title>An open‐label phase I trial of a live attenuated H2N2 influenza virus vaccine in healthy adults</article-title><alt-title alt-title-type="left-running-head">Talaat <italic>et al.</italic></alt-title><alt-title alt-title-type="right-running-head">H2N2 live attenuated influenza vaccine trial</alt-title></title-group><contrib-group><contrib id="cr1" contrib-type="author"><name><surname>Talaat</surname><given-names>Kawsar R.</given-names></name><xref ref-type="aff" rid="a1"><sup>1</sup></xref></contrib><contrib id="cr2" contrib-type="author"><name><surname>Karron</surname><given-names>Ruth A.</given-names></name><xref ref-type="aff" rid="a1"><sup>1</sup></xref></contrib><contrib id="cr3" contrib-type="author"><name><surname>Liang</surname><given-names>Philana H.</given-names></name><xref ref-type="aff" rid="a1"><sup>1</sup></xref></contrib><contrib id="cr4" contrib-type="author"><name><surname>McMahon</surname><given-names>Bridget A.</given-names></name><xref ref-type="aff" rid="a1"><sup>1</sup></xref></contrib><contrib id="cr5" contrib-type="author"><name><surname>Luke</surname><given-names>Catherine J.</given-names></name><xref ref-type="aff" rid="a2"><sup>2</sup></xref></contrib><contrib id="cr6" contrib-type="author"><name><surname>Thumar</surname><given-names>Bhagvanji</given-names></name><xref ref-type="aff" rid="a1"><sup>1</sup></xref></contrib><contrib id="cr7" contrib-type="author"><name><surname>Chen</surname><given-names>Grace L.</given-names></name><xref ref-type="aff" rid="a2"><sup>2</sup></xref></contrib><contrib id="cr8" contrib-type="author"><name><surname>Min</surname><given-names>Ji‐Young</given-names></name><xref ref-type="aff" rid="a2"><sup>2</sup></xref></contrib><contrib id="cr9" contrib-type="author"><name><surname>Lamirande</surname><given-names>Elaine W.</given-names></name><xref ref-type="aff" rid="a2"><sup>2</sup></xref></contrib><contrib id="cr10" contrib-type="author"><name><surname>Jin</surname><given-names>Hong</given-names></name><xref ref-type="aff" rid="a3"><sup>3</sup></xref></contrib><contrib id="cr11" contrib-type="author"><name><surname>Coelingh</surname><given-names>Kathy L.</given-names></name><xref ref-type="aff" rid="a3"><sup>3</sup></xref></contrib><contrib id="cr12" contrib-type="author"><name><surname>Kemble</surname><given-names>George W.</given-names></name><xref ref-type="aff" rid="a3"><sup>3</sup></xref></contrib><contrib id="cr13" contrib-type="author"><name><surname>Subbarao</surname><given-names>Kanta</given-names></name><xref ref-type="aff" rid="a2"><sup>2</sup></xref></contrib></contrib-group><aff id="a1"><label><sup>1</sup></label>Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.</aff><aff id="a2"><label><sup>2</sup></label>Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.</aff><aff id="a3"><label><sup>3</sup></label>MedImmune, Mountain View, CA, USA.</aff><author-notes><corresp id="correspondenceTo">Kawsar R. Talaat, Department of International Health, Hampton House Room 249, 624 N Broadway, Baltimore, MD 21205, USA. E‐mail: <email>ktalaat@jhsph.edu</email></corresp></author-notes><pub-date pub-type="epub"><day>14</day><month>3</month><year>2012</year></pub-date><pub-date pub-type="ppub"><month>1</month><year>2013</year></pub-date><volume>7</volume><issue>1</issue><issue-id pub-id-type="doi">10.1111/irv.2012.7.issue-1</issue-id><fpage>66</fpage><lpage>73</lpage><history>Accepted 14 January 2012. Published Online 14 March 2012.</history><permissions><copyright-statement content-type="article-copyright">Published 2012. This article is a US Government work and is in the public domain in the USA.</copyright-statement></permissions><self-uri content-type="pdf" xlink:type="simple" xlink:href="file:IRV-7-66.pdf"></self-uri><abstract><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></abstract><kwd-group><kwd id="k1">H2N2</kwd><kwd id="k2">human</kwd><kwd id="k3">influenza</kwd><kwd id="k4">influenza vaccine</kwd><kwd id="k5">live attenuated influenza vaccines</kwd><kwd id="k6">neuraminidase inhibition</kwd></kwd-group><counts><fig-count count="0"></fig-count><table-count count="3"></table-count><page-count count="8"></page-count></counts><custom-meta-group><custom-meta><meta-name>source-schema-version-number</meta-name><meta-value>2.0</meta-value></custom-meta><custom-meta><meta-name>cover-date</meta-name><meta-value>January 2013</meta-value></custom-meta><custom-meta><meta-name>details-of-publishers-convertor</meta-name><meta-value>Converter:WILEY_ML3GV2_TO_NLMPMC version:4.9.1 mode:remove_FC converted:12.07.2016</meta-value></custom-meta></custom-meta-group></article-meta><notes><fn-group><fn id="fn1"><p>This work was carried out at the Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205 (ClinicalTrials.gov Identifier: NCT00722774).</p></fn></fn-group></notes></front></pmc><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)
EXPLOR_STEP=$WICRI_ROOT/Sante/explor/H2N2V1/Data/Pmc/Checkpoint
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 000751 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Pmc/Checkpoint/biblio.hfd -nk 000751 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Sante
|area= H2N2V1
|flux= Pmc
|étape= Checkpoint
|type= RBID
|clé= PMC:3527634
|texte= An open‐label phase I trial of a live attenuated H2N2 influenza virus vaccine in healthy adults
}}
Pour générer des pages wiki
HfdIndexSelect -h $EXPLOR_AREA/Data/Pmc/Checkpoint/RBID.i -Sk "pubmed:22417012" \
| HfdSelect -Kh $EXPLOR_AREA/Data/Pmc/Checkpoint/biblio.hfd \
| NlmPubMed2Wicri -a H2N2V1
| This area was generated with Dilib version V0.6.33. |  |