H2N2V1, Ncbi, Merge, bibRecord, 000444

A Phase I Evaluation of Inactivated Influenza A/H5N1 Vaccine Administered by the Intradermal or the Intramuscular Route

Identifieur interne : 000444 ( Ncbi/Merge ); précédent : 000443; suivant : 000445

A Phase I Evaluation of Inactivated Influenza A/H5N1 Vaccine Administered by the Intradermal or the Intramuscular Route

Auteurs : Shital M. Patel [États-Unis] ; Robert L. Atmar [États-Unis] ; Hana El Sahly [États-Unis] ; Thomas R. Cate [États-Unis] ; Wendy A. Keitel [États-Unis]

Source :

Vaccine [ 0264-410X ] ; 2009.

RBID : PMC:2913582

Abstract

In a phase I clinical trial, one hundred healthy young adults were randomized to receive two doses 28 days apart of an inactivated, subvirion vaccine containing 15µg or 45µg of influenza A/H5N1 hemagglutinin (HA) by the intramuscular (IM) route, or 3µg or 9µg of H5 HA by the intradermal(ID) route. Seventy-seven subjects received a third dose. All regimens were safe and well tolerated. Antibody responses after two or three doses were low (≤20% or ≤38%, respectively) and similar in groups given 3µg or 9µg ID or 15µg IM, and were significantly lower than those given 45µg IM. Higher dosages of H5 HA and/or inclusion of adjuvant will be required to enhance immunogenicity by the ID route.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2913582

DOI: 10.1016/j.vaccine.2009.10.152
PubMed: 19931380
PubMed Central: 2913582

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PMC:2913582

Le document en format XML

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<front><div type="abstract" xml:lang="en"><p id="P1">In a phase I clinical trial, one hundred healthy young adults were randomized to receive two doses 28 days apart of an inactivated, subvirion vaccine containing 15µg or 45µg of influenza A/H5N1 hemagglutinin (HA) by the intramuscular (IM) route, or 3µg or 9µg of H5 HA by the intradermal(ID) route. Seventy-seven subjects received a third dose. All regimens were safe and well tolerated. Antibody responses after two or three doses were low (≤20% or ≤38%, respectively) and similar in groups given 3µg or 9µg ID or 15µg IM, and were significantly lower than those given 45µg IM. Higher dosages of H5 HA and/or inclusion of adjuvant will be required to enhance immunogenicity by the ID route.</p>
</div>
</front>
</TEI>
<pmc article-type="research-article" xml:lang="EN"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
  <pmc-dir>properties manuscript</pmc-dir>
  <front><journal-meta><journal-id journal-id-type="nlm-journal-id">8406899</journal-id>
<journal-id journal-id-type="pubmed-jr-id">7945</journal-id>
<journal-id journal-id-type="nlm-ta">Vaccine</journal-id>
<journal-title>Vaccine</journal-title>
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<article-id pub-id-type="manuscript">NIHMS183336</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Article</subject>
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<title-group><article-title>A Phase I Evaluation of Inactivated Influenza A/H5N1 Vaccine Administered by the Intradermal or the Intramuscular Route</article-title>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>Patel</surname>
<given-names>Shital M.</given-names>
</name>
<xref ref-type="aff" rid="A1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Atmar</surname>
<given-names>Robert L.</given-names>
</name>
<xref ref-type="aff" rid="A1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>El Sahly</surname>
<given-names>Hana</given-names>
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<contrib contrib-type="author"><name><surname>Cate</surname>
<given-names>Thomas R.</given-names>
</name>
<xref ref-type="aff" rid="A1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Keitel</surname>
<given-names>Wendy A.</given-names>
</name>
<xref ref-type="aff" rid="A1">1</xref>
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</contrib-group>
<aff id="A1"><label>1</label>
Baylor College of Medicine, One Baylor Plaza, MS: BCM280, Houston, Texas 77030, United States</aff>
<author-notes><corresp id="cor1">Corresponding Author: Shital Patel, M.D., Baylor College of Medicine 280, One Baylor Plaza, Houston, TX 77030, Telephone: 713-798-3793, Fax: 713-798-6802, <email>shitalp@bcm.edu</email>
</corresp>
<fn id="FN3" fn-type="conflict"><p id="P27">Potential Conflicts of Interest:</p>
<p id="P28">WAK, SMP, and HES: Research support from Protein Sciences, GlaxoSmithKline, Novartis</p>
<p id="P29">RLA: Consultant to GlaxoSmithKline</p>
<p id="P30">TRC: None</p>
</fn>
</author-notes>
<pub-date pub-type="nihms-submitted"><day>21</day>
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<year>2010</year>
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<pub-date pub-type="epub"><day>18</day>
<month>11</month>
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<pub-date pub-type="ppub"><day>9</day>
<month>4</month>
<year>2010</year>
</pub-date>
<pub-date pub-type="pmc-release"><day>9</day>
<month>4</month>
<year>2011</year>
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<volume>28</volume>
<issue>17</issue>
<fpage>3025</fpage>
<lpage>3029</lpage>
<permissions><copyright-statement>© 2009 Elsevier Ltd. All rights reserved.</copyright-statement>
<copyright-year>2009</copyright-year>
</permissions>
<abstract><p id="P1">In a phase I clinical trial, one hundred healthy young adults were randomized to receive two doses 28 days apart of an inactivated, subvirion vaccine containing 15µg or 45µg of influenza A/H5N1 hemagglutinin (HA) by the intramuscular (IM) route, or 3µg or 9µg of H5 HA by the intradermal(ID) route. Seventy-seven subjects received a third dose. All regimens were safe and well tolerated. Antibody responses after two or three doses were low (≤20% or ≤38%, respectively) and similar in groups given 3µg or 9µg ID or 15µg IM, and were significantly lower than those given 45µg IM. Higher dosages of H5 HA and/or inclusion of adjuvant will be required to enhance immunogenicity by the ID route.</p>
</abstract>
<kwd-group><kwd>Intradermal vaccination</kwd>
<kwd>Pandemic influenza</kwd>
<kwd>H5N1 vaccine</kwd>
</kwd-group>
<contract-num rid="AI1">N01 AI025465
				||AI</contract-num>
<contract-sponsor id="AI1">National Institute of Allergy and Infectious Diseases Extramural Activities : NIAID</contract-sponsor>
</article-meta>
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</pmc>
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<tree><country name="États-Unis"><noRegion><name sortKey="Patel, Shital M" sort="Patel, Shital M" uniqKey="Patel S" first="Shital M." last="Patel">Shital M. Patel</name>
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<name sortKey="Atmar, Robert L" sort="Atmar, Robert L" uniqKey="Atmar R" first="Robert L." last="Atmar">Robert L. Atmar</name>
<name sortKey="Cate, Thomas R" sort="Cate, Thomas R" uniqKey="Cate T" first="Thomas R." last="Cate">Thomas R. Cate</name>
<name sortKey="El Sahly, Hana" sort="El Sahly, Hana" uniqKey="El Sahly H" first="Hana" last="El Sahly">Hana El Sahly</name>
<name sortKey="Keitel, Wendy A" sort="Keitel, Wendy A" uniqKey="Keitel W" first="Wendy A." last="Keitel">Wendy A. Keitel</name>
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A Phase I Evaluation of Inactivated Influenza A/H5N1 Vaccine Administered by the Intradermal or the Intramuscular Route

A Phase I Evaluation of Inactivated Influenza A/H5N1 Vaccine Administered by the Intradermal or the Intramuscular Route

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Abstract

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