Extrapolating theoretical efficacy of inactivated influenza A/H5N1 virus vaccine from human immunogenicity studies
Identifieur interne : 000864 ( Pmc/Curation ); précédent : 000863; suivant : 000865Extrapolating theoretical efficacy of inactivated influenza A/H5N1 virus vaccine from human immunogenicity studies
Auteurs : Leora R. Feldstein [États-Unis] ; Laura Matrajt [États-Unis] ; M. Elizabeth Halloran [États-Unis] ; Wendy A. Keitel [États-Unis] ; Ira M. Longini [États-Unis]Source :
- Vaccine [ 0264-410X ] ; 2016.
Abstract
Influenza A virus subtype H5N1 has been a public health concern for almost 20 years due to its potential ability to become transmissible among humans. Phase I and II clinical trials have assessed safety, reactogenicity and immunogenicity of inactivated influenza A/H5N1 virus vaccines. A shortage of vaccine is likely to occur during the first months of a pandemic. Hence, determining whether to give one dose to more people or two doses to fewer people to best protect the population is essential. We use hemagglutination-inhibition antibody titers as an immune correlate for avian influenza vaccines. Using an established relationship to obtain a theoretical vaccine efficacy from immunogenicity data from thirteen arms of six phase I and phase II clinical trials of inactivated influenza A/H5N1 virus vaccines, we assessed: 1) the proportion of theoretical vaccine efficacy achieved after a single dose (defined as primary response level), and 2) whether theoretical efficacy increases after a second dose, with and without adjuvant. Participants receiving vaccine with AS03 adjuvant had higher primary response levels (range: 0.48–0.57) compared to participants receiving vaccine with MF59 adjuvant (range: 0.32–0.47), with no observed trends in primary response levels by antigen dosage. After the first and second doses, vaccine with AS03 at dosage levels 3.75, 7.5 and 15 mcg had the highest estimated theoretical vaccine efficacy: Dose 1) 45% (95%CI: 36–57%), 53% (95%CI: 42–63%) and 55% (95%CI: 44–64%), respectively and Dose 2) 93% (95%CI: 89–96%), 97% (95%CI: 95–98%) and 97% (95%CI: 96–100%), respectively. On average, the estimated theoretical vaccine efficacy of lower dose adjuvanted vaccines (AS03 and MF59) was 17% higher than that of higher dose unadjuvanted vaccines, suggesting that including an adjuvant is dose-sparing. These data indicate adjuvanted inactivated influenza A/H5N1 virus vaccine produces high theoretical efficacy after two doses to protect individuals against a potential avian influenza pandemic.
Url:
DOI: 10.1016/j.vaccine.2016.05.067
PubMed: 27268778
PubMed Central: 5168719
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<front><div type="abstract" xml:lang="en"><p id="P2">Influenza A virus subtype H5N1 has been a public health concern for almost 20 years due to its potential ability to become transmissible among humans. Phase I and II clinical trials have assessed safety, reactogenicity and immunogenicity of inactivated influenza A/H5N1 virus vaccines. A shortage of vaccine is likely to occur during the first months of a pandemic. Hence, determining whether to give one dose to more people or two doses to fewer people to best protect the population is essential. We use hemagglutination-inhibition antibody titers as an immune correlate for avian influenza vaccines. Using an established relationship to obtain a theoretical vaccine efficacy from immunogenicity data from thirteen arms of six phase I and phase II clinical trials of inactivated influenza A/H5N1 virus vaccines, we assessed: 1) the proportion of theoretical vaccine efficacy achieved after a single dose (defined as primary response level), and 2) whether theoretical efficacy increases after a second dose, with and without adjuvant. Participants receiving vaccine with AS03 adjuvant had higher primary response levels (range: 0.48–0.57) compared to participants receiving vaccine with MF59 adjuvant (range: 0.32–0.47), with no observed trends in primary response levels by antigen dosage. After the first and second doses, vaccine with AS03 at dosage levels 3.75, 7.5 and 15 mcg had the highest estimated theoretical vaccine efficacy: Dose 1) 45% (95%CI: 36–57%), 53% (95%CI: 42–63%) and 55% (95%CI: 44–64%), respectively and Dose 2) 93% (95%CI: 89–96%), 97% (95%CI: 95–98%) and 97% (95%CI: 96–100%), respectively. On average, the estimated theoretical vaccine efficacy of lower dose adjuvanted vaccines (AS03 and MF59) was 17% higher than that of higher dose unadjuvanted vaccines, suggesting that including an adjuvant is dose-sparing. These data indicate adjuvanted inactivated influenza A/H5N1 virus vaccine produces high theoretical efficacy after two doses to protect individuals against a potential avian influenza pandemic.</p>
</div>
</front>
</TEI>
<pmc article-type="research-article"><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-id journal-id-type="iso-abbrev">Vaccine</journal-id>
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<issn pub-type="epub">1873-2518</issn>
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<article-id pub-id-type="doi">10.1016/j.vaccine.2016.05.067</article-id>
<article-id pub-id-type="manuscript">NIHMS832541</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Article</subject>
</subj-group>
</article-categories>
<title-group><article-title>Extrapolating theoretical efficacy of inactivated influenza A/H5N1 virus vaccine from human immunogenicity studies</article-title>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>Feldstein</surname>
<given-names>Leora R.</given-names>
</name>
<xref ref-type="aff" rid="A1">a</xref>
<xref ref-type="aff" rid="A2">b</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Matrajt</surname>
<given-names>Laura</given-names>
</name>
<xref ref-type="aff" rid="A2">b</xref>
<xref ref-type="aff" rid="A3">c</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Halloran</surname>
<given-names>M. Elizabeth</given-names>
</name>
<xref ref-type="aff" rid="A2">b</xref>
<xref ref-type="aff" rid="A3">c</xref>
<xref ref-type="aff" rid="A4">d</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Keitel</surname>
<given-names>Wendy A.</given-names>
</name>
<xref ref-type="aff" rid="A5">e</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Longini</surname>
<given-names>Ira M.</given-names>
<suffix>Jr.</suffix>
</name>
<xref ref-type="aff" rid="A3">c</xref>
<xref ref-type="aff" rid="A6">f</xref>
</contrib>
<contrib contrib-type="author"><collab>H5N1 Vaccine Working Group</collab>
<xref ref-type="author-notes" rid="FN1">1</xref>
</contrib>
</contrib-group>
<aff id="A1"><label>a</label>
Department of Epidemiology, School of Public Health, University of Washington School, Seattle, WA</aff>
<aff id="A2"><label>b</label>
Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA</aff>
<aff id="A3"><label>c</label>
Center for Inference and Dynamics of Infectious Diseases, Fred Hutchinson Cancer Research Center, Seattle, WA</aff>
<aff id="A4"><label>d</label>
Department of Biostatistics, School of Public Health, University of Washington, Seattle, WA</aff>
<aff id="A5"><label>e</label>
Department of Medicine, Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas</aff>
<aff id="A6"><label>f</label>
Department of Biostatistics, College of Public Health and Health Professions and College of Medicine, University of Florida, Gainesville, Florida</aff>
<author-notes><corresp id="cor1"><bold>Corresponding author:</bold>
P.O. Box 117450, 22 Buckman Drive, 452 Dauer Hall University of Florida, Gainesville, FL 32611, <bold>Tel:</bold>
352-294-1938; Fax: (352) 294-1930. <email>ilongini@ufl.edu</email>
(Ira M. Longini Jr.)</corresp>
<fn id="FN1"><label>1</label>
<p id="P1">Keitel WA, Atmar RL, (Baylor College of Medicine, Houston, TX), Brady RC, Frenck RW, (Cincinnati Children’s Hospital Medical Center, Cincinnati, OH), Walter EB, Woods CW, (Duke University School of Medicine, Durham, NC), Mulligan MJ, Spearman P, (Emory University School of Medicine, Atlanta, GA), Jackson LA, (Group Health Cooperative, Seattle WA), Belshe RB, Frey SE, (Saint Louis University School of Medicine, St. Louis, MO), Winokur PL, Stapleton JT, (University of Iowa and Iowa City VA Medical Center, Iowa City, IA), Chen WH, Kotloff KL, (University of Maryland School of Medicine, Baltimore, MD), Edwards KM, Creech CB (Vanderbilt University School of Medicine, Nashville, TN).</p>
</fn>
</author-notes>
<pub-date pub-type="nihms-submitted"><day>14</day>
<month>12</month>
<year>2016</year>
</pub-date>
<pub-date pub-type="epub"><day>20</day>
<month>6</month>
<year>2016</year>
</pub-date>
<pub-date pub-type="ppub"><day>19</day>
<month>7</month>
<year>2016</year>
</pub-date>
<pub-date pub-type="pmc-release"><day>19</day>
<month>7</month>
<year>2017</year>
</pub-date>
<volume>34</volume>
<issue>33</issue>
<fpage>3796</fpage>
<lpage>3802</lpage>
<pmc-comment>elocation-id from pubmed: 10.1016/j.vaccine.2016.05.067</pmc-comment>
<abstract><p id="P2">Influenza A virus subtype H5N1 has been a public health concern for almost 20 years due to its potential ability to become transmissible among humans. Phase I and II clinical trials have assessed safety, reactogenicity and immunogenicity of inactivated influenza A/H5N1 virus vaccines. A shortage of vaccine is likely to occur during the first months of a pandemic. Hence, determining whether to give one dose to more people or two doses to fewer people to best protect the population is essential. We use hemagglutination-inhibition antibody titers as an immune correlate for avian influenza vaccines. Using an established relationship to obtain a theoretical vaccine efficacy from immunogenicity data from thirteen arms of six phase I and phase II clinical trials of inactivated influenza A/H5N1 virus vaccines, we assessed: 1) the proportion of theoretical vaccine efficacy achieved after a single dose (defined as primary response level), and 2) whether theoretical efficacy increases after a second dose, with and without adjuvant. Participants receiving vaccine with AS03 adjuvant had higher primary response levels (range: 0.48–0.57) compared to participants receiving vaccine with MF59 adjuvant (range: 0.32–0.47), with no observed trends in primary response levels by antigen dosage. After the first and second doses, vaccine with AS03 at dosage levels 3.75, 7.5 and 15 mcg had the highest estimated theoretical vaccine efficacy: Dose 1) 45% (95%CI: 36–57%), 53% (95%CI: 42–63%) and 55% (95%CI: 44–64%), respectively and Dose 2) 93% (95%CI: 89–96%), 97% (95%CI: 95–98%) and 97% (95%CI: 96–100%), respectively. On average, the estimated theoretical vaccine efficacy of lower dose adjuvanted vaccines (AS03 and MF59) was 17% higher than that of higher dose unadjuvanted vaccines, suggesting that including an adjuvant is dose-sparing. These data indicate adjuvanted inactivated influenza A/H5N1 virus vaccine produces high theoretical efficacy after two doses to protect individuals against a potential avian influenza pandemic.</p>
</abstract>
</article-meta>
</front>
</pmc>
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