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<title xml:lang="en">Restoration of anti-tetanus toxoid responses in patients initiating highly active antiretroviral therapy with or without a boost immunization: an INITIO substudy</title>
<author>
<name sortKey="Burton, C T" sort="Burton, C T" uniqKey="Burton C" first="C T" last="Burton">C T Burton</name>
<affiliation>
<nlm:aff id="au1">
<institution>Imperial College London</institution>
<addr-line>London, UK</addr-line>
</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Goodall, R L" sort="Goodall, R L" uniqKey="Goodall R" first="R L" last="Goodall">R L Goodall</name>
<affiliation>
<nlm:aff id="au2">
<institution>MRC Clinical Trials Unit</institution>
<addr-line>London, UK</addr-line>
</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Samri, A" sort="Samri, A" uniqKey="Samri A" first="A" last="Samri">A. Samri</name>
<affiliation>
<nlm:aff id="au3">
<institution>Laboratoire d'Immunologie Cellulaire, AP-HP, Hôpital Pitié-Salpêtrière, INSERM UMR S 543 Université Pierre et Marie Curie-Paris 6</institution>
<addr-line>Paris, France</addr-line>
</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Autran, B" sort="Autran, B" uniqKey="Autran B" first="B" last="Autran">B. Autran</name>
<affiliation>
<nlm:aff id="au3">
<institution>Laboratoire d'Immunologie Cellulaire, AP-HP, Hôpital Pitié-Salpêtrière, INSERM UMR S 543 Université Pierre et Marie Curie-Paris 6</institution>
<addr-line>Paris, France</addr-line>
</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Kelleher, A D" sort="Kelleher, A D" uniqKey="Kelleher A" first="A D" last="Kelleher">A D Kelleher</name>
<affiliation>
<nlm:aff id="au4">
<institution>National Centre in HIV Epidemiology and Clinical Research, University of New South Wales</institution>
<addr-line>Darlinghurst, Australia</addr-line>
</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Poli, G" sort="Poli, G" uniqKey="Poli G" first="G" last="Poli">G. Poli</name>
<affiliation>
<nlm:aff id="au5">
<institution>San Raffaele Scientific Institute and Vita-salute San Raffaele University</institution>
<addr-line>Milano, Italy</addr-line>
</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Pantaleo, G" sort="Pantaleo, G" uniqKey="Pantaleo G" first="G" last="Pantaleo">G. Pantaleo</name>
<affiliation>
<nlm:aff id="au6">
<institution>University of Lausanne</institution>
<addr-line>Lausanne, Switzerland</addr-line>
</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Gotch, F M" sort="Gotch, F M" uniqKey="Gotch F" first="F M" last="Gotch">F M Gotch</name>
<affiliation>
<nlm:aff id="au1">
<institution>Imperial College London</institution>
<addr-line>London, UK</addr-line>
</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Imami, N" sort="Imami, N" uniqKey="Imami N" first="N" last="Imami">N. Imami</name>
<affiliation>
<nlm:aff id="au1">
<institution>Imperial College London</institution>
<addr-line>London, UK</addr-line>
</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Imami, N" sort="Imami, N" uniqKey="Imami N" first="N" last="Imami">N. Imami</name>
<affiliation>
<nlm:aff id="au1">
<institution>Imperial College London</institution>
<addr-line>London, UK</addr-line>
</nlm:aff>
</affiliation>
</author>
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<idno type="pmid">18410636</idno>
<idno type="pmc">2384099</idno>
<idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2384099</idno>
<idno type="RBID">PMC:2384099</idno>
<idno type="doi">10.1111/j.1365-2249.2008.03611.x</idno>
<date when="2008">2008</date>
<idno type="wicri:Area/Pmc/Corpus">001376</idno>
<idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">001376</idno>
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<analytic>
<title xml:lang="en" level="a" type="main">Restoration of anti-tetanus toxoid responses in patients initiating highly active antiretroviral therapy with or without a boost immunization: an INITIO substudy</title>
<author>
<name sortKey="Burton, C T" sort="Burton, C T" uniqKey="Burton C" first="C T" last="Burton">C T Burton</name>
<affiliation>
<nlm:aff id="au1">
<institution>Imperial College London</institution>
<addr-line>London, UK</addr-line>
</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Goodall, R L" sort="Goodall, R L" uniqKey="Goodall R" first="R L" last="Goodall">R L Goodall</name>
<affiliation>
<nlm:aff id="au2">
<institution>MRC Clinical Trials Unit</institution>
<addr-line>London, UK</addr-line>
</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Samri, A" sort="Samri, A" uniqKey="Samri A" first="A" last="Samri">A. Samri</name>
<affiliation>
<nlm:aff id="au3">
<institution>Laboratoire d'Immunologie Cellulaire, AP-HP, Hôpital Pitié-Salpêtrière, INSERM UMR S 543 Université Pierre et Marie Curie-Paris 6</institution>
<addr-line>Paris, France</addr-line>
</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Autran, B" sort="Autran, B" uniqKey="Autran B" first="B" last="Autran">B. Autran</name>
<affiliation>
<nlm:aff id="au3">
<institution>Laboratoire d'Immunologie Cellulaire, AP-HP, Hôpital Pitié-Salpêtrière, INSERM UMR S 543 Université Pierre et Marie Curie-Paris 6</institution>
<addr-line>Paris, France</addr-line>
</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Kelleher, A D" sort="Kelleher, A D" uniqKey="Kelleher A" first="A D" last="Kelleher">A D Kelleher</name>
<affiliation>
<nlm:aff id="au4">
<institution>National Centre in HIV Epidemiology and Clinical Research, University of New South Wales</institution>
<addr-line>Darlinghurst, Australia</addr-line>
</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Poli, G" sort="Poli, G" uniqKey="Poli G" first="G" last="Poli">G. Poli</name>
<affiliation>
<nlm:aff id="au5">
<institution>San Raffaele Scientific Institute and Vita-salute San Raffaele University</institution>
<addr-line>Milano, Italy</addr-line>
</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Pantaleo, G" sort="Pantaleo, G" uniqKey="Pantaleo G" first="G" last="Pantaleo">G. Pantaleo</name>
<affiliation>
<nlm:aff id="au6">
<institution>University of Lausanne</institution>
<addr-line>Lausanne, Switzerland</addr-line>
</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Gotch, F M" sort="Gotch, F M" uniqKey="Gotch F" first="F M" last="Gotch">F M Gotch</name>
<affiliation>
<nlm:aff id="au1">
<institution>Imperial College London</institution>
<addr-line>London, UK</addr-line>
</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Imami, N" sort="Imami, N" uniqKey="Imami N" first="N" last="Imami">N. Imami</name>
<affiliation>
<nlm:aff id="au1">
<institution>Imperial College London</institution>
<addr-line>London, UK</addr-line>
</nlm:aff>
</affiliation>
</author>
<author>
<name sortKey="Imami, N" sort="Imami, N" uniqKey="Imami N" first="N" last="Imami">N. Imami</name>
<affiliation>
<nlm:aff id="au1">
<institution>Imperial College London</institution>
<addr-line>London, UK</addr-line>
</nlm:aff>
</affiliation>
</author>
</analytic>
<series>
<title level="j">Clinical and Experimental Immunology</title>
<idno type="ISSN">0009-9104</idno>
<idno type="eISSN">1365-2249</idno>
<imprint>
<date when="2008">2008</date>
</imprint>
</series>
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<front>
<div type="abstract" xml:lang="en">
<p>INITIO is an open-labelled randomized trial evaluating first-line therapeutic strategies for human immunodeficiency virus-1 (HIV-1) infection. In an immunology substudy a tetanus toxoid booster (TTB) immunization was planned for 24 weeks after initiation of highly active antiretroviral therapy (HAART). All patients had received tetanus toxoid immunization in childhood. Generation of proliferative responses to tetanus toxoid was compared in two groups of patients, those receiving a protease inhibitor (PI)-sparing regimen (
<italic>n</italic>
= 21) and those receiving a PI-containing (
<italic>n</italic>
= 54) regimen. Fifty-two participants received a TTB immunization [PI-sparing (
<italic>n</italic>
= 15), PI-containing (
<italic>n</italic>
= 37)] and 23 participants did not [PI-sparing (
<italic>n</italic>
= 6) or PI-containing (
<italic>n</italic>
= 17)]. Cellular responses to tetanus antigen were monitored by lymphoproliferation at time of immunization and every 24 weeks to week 156. Proportions with a positive response (defined as stimulation index ≥ 3 and Δ counts per minute ≥ 3000) were compared at weeks 96 and 156. All analyses were intent-to-treat. Fifty-two participants had a TTB immunization at median 25 weeks; 23 patients did not. At weeks 96 and 156 there was no evidence of a difference in tetanus-specific responses, between those with or without TTB immunization (
<italic>P</italic>
= 0·2,
<italic>P</italic>
= 0·4). There was no difference in the proportion with response between those with PI-sparing or PI-containing regimens at both time-points (
<italic>P</italic>
= 0·8,
<italic>P</italic>
= 0·7). The proliferative response to tetanus toxoid was unaffected by initial HAART regimen. Anti-tetanus responses appear to reconstitute eventually in most patients over 156 weeks when treated successfully with HAART, irrespective of whether or not a TTB immunization has been administered.</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>
<front>
<journal-meta>
<journal-id journal-id-type="nlm-ta">Clin Exp Immunol</journal-id>
<journal-id journal-id-type="publisher-id">cei</journal-id>
<journal-title>Clinical and Experimental Immunology</journal-title>
<issn pub-type="ppub">0009-9104</issn>
<issn pub-type="epub">1365-2249</issn>
<publisher>
<publisher-name>Blackwell Science Inc</publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id pub-id-type="pmid">18410636</article-id>
<article-id pub-id-type="pmc">2384099</article-id>
<article-id pub-id-type="doi">10.1111/j.1365-2249.2008.03611.x</article-id>
<article-categories>
<subj-group subj-group-type="heading">
<subject>Translational Studies</subject>
<subj-group>
<subject>Infection</subject>
</subj-group>
</subj-group>
</article-categories>
<title-group>
<article-title>Restoration of anti-tetanus toxoid responses in patients initiating highly active antiretroviral therapy with or without a boost immunization: an INITIO substudy</article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname>Burton</surname>
<given-names>C T</given-names>
</name>
<xref ref-type="aff" rid="au1">*</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Goodall</surname>
<given-names>R L</given-names>
</name>
<xref ref-type="aff" rid="au2"></xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Samri</surname>
<given-names>A</given-names>
</name>
<xref ref-type="aff" rid="au3"></xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Autran</surname>
<given-names>B</given-names>
</name>
<xref ref-type="aff" rid="au3"></xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Kelleher</surname>
<given-names>A D</given-names>
</name>
<xref ref-type="aff" rid="au4">§</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Poli</surname>
<given-names>G</given-names>
</name>
<xref ref-type="aff" rid="au5"></xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Pantaleo</surname>
<given-names>G</given-names>
</name>
<xref ref-type="aff" rid="au6">**</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Gotch</surname>
<given-names>F M</given-names>
</name>
<xref ref-type="aff" rid="au1">*</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Imami</surname>
<given-names>N</given-names>
</name>
<xref ref-type="aff" rid="au1">*</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Imami</surname>
<given-names>N</given-names>
</name>
<on-behalf-of>the INITIO Trial International Co-ordinating Committee</on-behalf-of>
<xref ref-type="aff" rid="au1">*</xref>
</contrib>
<aff id="au1">
<label>*</label>
<institution>Imperial College London</institution>
<addr-line>London, UK</addr-line>
</aff>
<aff id="au2">
<label></label>
<institution>MRC Clinical Trials Unit</institution>
<addr-line>London, UK</addr-line>
</aff>
<aff id="au3">
<label></label>
<institution>Laboratoire d'Immunologie Cellulaire, AP-HP, Hôpital Pitié-Salpêtrière, INSERM UMR S 543 Université Pierre et Marie Curie-Paris 6</institution>
<addr-line>Paris, France</addr-line>
</aff>
<aff id="au4">
<label>§</label>
<institution>National Centre in HIV Epidemiology and Clinical Research, University of New South Wales</institution>
<addr-line>Darlinghurst, Australia</addr-line>
</aff>
<aff id="au5">
<label></label>
<institution>San Raffaele Scientific Institute and Vita-salute San Raffaele University</institution>
<addr-line>Milano, Italy</addr-line>
</aff>
<aff id="au6">
<label>**</label>
<institution>University of Lausanne</institution>
<addr-line>Lausanne, Switzerland</addr-line>
</aff>
</contrib-group>
<author-notes>
<corresp id="cor1">Correspondence: N. Imami, Department of Immunology, Imperial College London, Chelsea and Westminster Hospital, 369 Fulham Road, London SW10 9NH, UK. E-mail:
<email>n.imami@imperial.ac.uk</email>
</corresp>
</author-notes>
<pub-date pub-type="ppub">
<month>5</month>
<year>2008</year>
</pub-date>
<volume>152</volume>
<issue>2</issue>
<fpage>252</fpage>
<lpage>257</lpage>
<history>
<date date-type="accepted">
<day>10</day>
<month>1</month>
<year>2008</year>
</date>
</history>
<copyright-statement>© 2008 British Society for Immunology</copyright-statement>
<copyright-year>2008</copyright-year>
<abstract>
<p>INITIO is an open-labelled randomized trial evaluating first-line therapeutic strategies for human immunodeficiency virus-1 (HIV-1) infection. In an immunology substudy a tetanus toxoid booster (TTB) immunization was planned for 24 weeks after initiation of highly active antiretroviral therapy (HAART). All patients had received tetanus toxoid immunization in childhood. Generation of proliferative responses to tetanus toxoid was compared in two groups of patients, those receiving a protease inhibitor (PI)-sparing regimen (
<italic>n</italic>
= 21) and those receiving a PI-containing (
<italic>n</italic>
= 54) regimen. Fifty-two participants received a TTB immunization [PI-sparing (
<italic>n</italic>
= 15), PI-containing (
<italic>n</italic>
= 37)] and 23 participants did not [PI-sparing (
<italic>n</italic>
= 6) or PI-containing (
<italic>n</italic>
= 17)]. Cellular responses to tetanus antigen were monitored by lymphoproliferation at time of immunization and every 24 weeks to week 156. Proportions with a positive response (defined as stimulation index ≥ 3 and Δ counts per minute ≥ 3000) were compared at weeks 96 and 156. All analyses were intent-to-treat. Fifty-two participants had a TTB immunization at median 25 weeks; 23 patients did not. At weeks 96 and 156 there was no evidence of a difference in tetanus-specific responses, between those with or without TTB immunization (
<italic>P</italic>
= 0·2,
<italic>P</italic>
= 0·4). There was no difference in the proportion with response between those with PI-sparing or PI-containing regimens at both time-points (
<italic>P</italic>
= 0·8,
<italic>P</italic>
= 0·7). The proliferative response to tetanus toxoid was unaffected by initial HAART regimen. Anti-tetanus responses appear to reconstitute eventually in most patients over 156 weeks when treated successfully with HAART, irrespective of whether or not a TTB immunization has been administered.</p>
</abstract>
<kwd-group>
<kwd>HAART</kwd>
<kwd>HIV-1</kwd>
<kwd>NNRTI</kwd>
<kwd>PI</kwd>
<kwd>tetanus toxoid</kwd>
</kwd-group>
</article-meta>
</front>
</pmc>
</record>

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