Long-term immunogenicity of the influenza vaccine at reduced intradermal and full intramuscular doses among healthy young adults
Identifieur interne : 000577 ( Pmc/Checkpoint ); précédent : 000576; suivant : 000578Long-term immunogenicity of the influenza vaccine at reduced intradermal and full intramuscular doses among healthy young adults
Auteurs : Joon Young Song [Corée du Sud] ; Hee Jin Cheong [Corée du Sud] ; Ji Yun Noh [Corée du Sud] ; Tae Un Yang [Corée du Sud] ; Yu Bin Seo [Corée du Sud] ; Kyung-Wook Hong [Corée du Sud] ; In Seon Kim [Corée du Sud] ; Won Suk Choi [Corée du Sud] ; Woo Joo Kim [Corée du Sud]Source :
- Clinical and Experimental Vaccine Research [ 2287-3651 ] ; 2013.
Abstract
To prepare for vaccine shortages under an influenza pandemic, several antigen-sparing strategies have been investigated. This study was aimed to evaluate the immunogenicity of influenza vaccine at reduced intradermal and full intramuscular dose.
We compared the effect of one-fifth and one-half intradermal doses to the full intramuscular dose on immunogenicity in healthy young adults, using a commercial influenza vaccine. A hemagglutination inhibition assay was used to compare the immunogenicity of the vaccination methods.
The one-fifth intradermal dose (3 µg hemagglutinin antigen, HA) was given to 30 participants, the one-half intradermal dose (7.5 µg HA) was given to 30, and the full intramuscular dose (15 µg HA) was given to 32. No significant differences among injection routes and dosages were seen for seroprotection rate, seroconversion rate, or geometric mean titer (GMT) fold-increase for A/H1N1, A/H3N2, and B at around 4 weeks from vaccination. Although GMT for influenza B was significantly lower at six months for the one-fifth intradermal vaccination compared to the full-dose intramuscular vaccination (32.8 vs. 63.2, p=0.048), all three groups met the Evaluation of Medicinal Products (EMA) immunogenicity criteria through 1 to 6 months.
Intradermal administration of a one-fifth dose of influenza vaccine elicited antibody responses comparable to the intradermal one-half dose and a conventional intramuscular vaccination at 1 month post-vaccination. The immunogenicity of the one-fifth intradermal dose was sufficient to meet the requirement for the EMA criteria at six months after influenza vaccination.
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DOI: 10.7774/cevr.2013.2.2.115
PubMed: 23858402
PubMed Central: 3710919
Affiliations:
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<front><div type="abstract" xml:lang="en"><sec><title>Purpose</title>
<p>To prepare for vaccine shortages under an influenza pandemic, several antigen-sparing strategies have been investigated. This study was aimed to evaluate the immunogenicity of influenza vaccine at reduced intradermal and full intramuscular dose.</p>
</sec>
<sec><title>Materials and Methods</title>
<p>We compared the effect of one-fifth and one-half intradermal doses to the full intramuscular dose on immunogenicity in healthy young adults, using a commercial influenza vaccine. A hemagglutination inhibition assay was used to compare the immunogenicity of the vaccination methods.</p>
</sec>
<sec><title>Results</title>
<p>The one-fifth intradermal dose (3 µg hemagglutinin antigen, HA) was given to 30 participants, the one-half intradermal dose (7.5 µg HA) was given to 30, and the full intramuscular dose (15 µg HA) was given to 32. No significant differences among injection routes and dosages were seen for seroprotection rate, seroconversion rate, or geometric mean titer (GMT) fold-increase for A/H1N1, A/H3N2, and B at around 4 weeks from vaccination. Although GMT for influenza B was significantly lower at six months for the one-fifth intradermal vaccination compared to the full-dose intramuscular vaccination (32.8 vs. 63.2, p=0.048), all three groups met the Evaluation of Medicinal Products (EMA) immunogenicity criteria through 1 to 6 months.</p>
</sec>
<sec><title>Conclusion</title>
<p>Intradermal administration of a one-fifth dose of influenza vaccine elicited antibody responses comparable to the intradermal one-half dose and a conventional intramuscular vaccination at 1 month post-vaccination. The immunogenicity of the one-fifth intradermal dose was sufficient to meet the requirement for the EMA criteria at six months after influenza vaccination.</p>
</sec>
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<pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Clin Exp Vaccine Res</journal-id>
<journal-id journal-id-type="iso-abbrev">Clin Exp Vaccine Res</journal-id>
<journal-id journal-id-type="publisher-id">CEVR</journal-id>
<journal-title-group><journal-title>Clinical and Experimental Vaccine Research</journal-title>
</journal-title-group>
<issn pub-type="ppub">2287-3651</issn>
<issn pub-type="epub">2287-366X</issn>
<publisher><publisher-name>The Korean Vaccine Society</publisher-name>
</publisher>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">23858402</article-id>
<article-id pub-id-type="pmc">3710919</article-id>
<article-id pub-id-type="doi">10.7774/cevr.2013.2.2.115</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Original Article</subject>
</subj-group>
</article-categories>
<title-group><article-title>Long-term immunogenicity of the influenza vaccine at reduced intradermal and full intramuscular doses among healthy young adults</article-title>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>Song</surname>
<given-names>Joon Young</given-names>
</name>
<xref ref-type="aff" rid="A1">1</xref>
<xref ref-type="aff" rid="A2">2</xref>
</contrib>
<contrib contrib-type="author" corresp="yes"><name><surname>Cheong</surname>
<given-names>Hee Jin</given-names>
</name>
<xref ref-type="aff" rid="A1">1</xref>
<xref ref-type="aff" rid="A2">2</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Noh</surname>
<given-names>Ji Yun</given-names>
</name>
<xref ref-type="aff" rid="A1">1</xref>
<xref ref-type="aff" rid="A2">2</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Yang</surname>
<given-names>Tae Un</given-names>
</name>
<xref ref-type="aff" rid="A1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Seo</surname>
<given-names>Yu Bin</given-names>
</name>
<xref ref-type="aff" rid="A1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Hong</surname>
<given-names>Kyung-Wook</given-names>
</name>
<xref ref-type="aff" rid="A1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Kim</surname>
<given-names>In Seon</given-names>
</name>
<xref ref-type="aff" rid="A1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Choi</surname>
<given-names>Won Suk</given-names>
</name>
<xref ref-type="aff" rid="A1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Kim</surname>
<given-names>Woo Joo</given-names>
</name>
<xref ref-type="aff" rid="A1">1</xref>
<xref ref-type="aff" rid="A2">2</xref>
</contrib>
</contrib-group>
<aff id="A1"><label>1</label>
Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.</aff>
<aff id="A2"><label>2</label>
Asian Pacific Influenza Institute, Korea University College of Medicine, Seoul, Korea.</aff>
<author-notes><corresp>Corresponding author: Hee Jin Cheong, MD, PhD. Division of Infectious Disease, Department of Internal Medicine, Korea University Guro Hospital, 148 Gurodong-ro, Guro-gu, Seoul 152-703, Korea. Tel: +82-2-2626-3050, Fax: +82-2-2626-1105, <email>heejinmd@medimail.co.kr</email>
</corresp>
</author-notes>
<pub-date pub-type="ppub"><month>7</month>
<year>2013</year>
</pub-date>
<pub-date pub-type="epub"><day>03</day>
<month>7</month>
<year>2013</year>
</pub-date>
<volume>2</volume>
<issue>2</issue>
<fpage>115</fpage>
<lpage>119</lpage>
<history><date date-type="received"><day>21</day>
<month>3</month>
<year>2013</year>
</date>
<date date-type="rev-recd"><day>31</day>
<month>3</month>
<year>2013</year>
</date>
<date date-type="accepted"><day>10</day>
<month>4</month>
<year>2013</year>
</date>
</history>
<permissions><copyright-statement>© Korean Vaccine Society.</copyright-statement>
<copyright-year>2013</copyright-year>
<license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by-nc/3.0/"><license-p>This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by-nc/3.0/">http://creativecommons.org/licenses/by-nc/3.0/</ext-link>
) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
</license>
</permissions>
<abstract><sec><title>Purpose</title>
<p>To prepare for vaccine shortages under an influenza pandemic, several antigen-sparing strategies have been investigated. This study was aimed to evaluate the immunogenicity of influenza vaccine at reduced intradermal and full intramuscular dose.</p>
</sec>
<sec><title>Materials and Methods</title>
<p>We compared the effect of one-fifth and one-half intradermal doses to the full intramuscular dose on immunogenicity in healthy young adults, using a commercial influenza vaccine. A hemagglutination inhibition assay was used to compare the immunogenicity of the vaccination methods.</p>
</sec>
<sec><title>Results</title>
<p>The one-fifth intradermal dose (3 µg hemagglutinin antigen, HA) was given to 30 participants, the one-half intradermal dose (7.5 µg HA) was given to 30, and the full intramuscular dose (15 µg HA) was given to 32. No significant differences among injection routes and dosages were seen for seroprotection rate, seroconversion rate, or geometric mean titer (GMT) fold-increase for A/H1N1, A/H3N2, and B at around 4 weeks from vaccination. Although GMT for influenza B was significantly lower at six months for the one-fifth intradermal vaccination compared to the full-dose intramuscular vaccination (32.8 vs. 63.2, p=0.048), all three groups met the Evaluation of Medicinal Products (EMA) immunogenicity criteria through 1 to 6 months.</p>
</sec>
<sec><title>Conclusion</title>
<p>Intradermal administration of a one-fifth dose of influenza vaccine elicited antibody responses comparable to the intradermal one-half dose and a conventional intramuscular vaccination at 1 month post-vaccination. The immunogenicity of the one-fifth intradermal dose was sufficient to meet the requirement for the EMA criteria at six months after influenza vaccination.</p>
</sec>
</abstract>
<kwd-group><kwd>Vaccines</kwd>
<kwd>Influenza vaccines</kwd>
<kwd>Immunogenicity</kwd>
<kwd>Intradermal injections</kwd>
<kwd>Adult</kwd>
</kwd-group>
</article-meta>
</front>
<floats-group><fig id="F1" orientation="portrait" position="float"><label>Fig. 1</label>
<caption><p>A total of 96 healthy adults were enrolled in the study and assigned to one of three vaccination regimens, receiving intradermal (ID) one-fifth dose (0.1 mL, 3 ±g hemagglutinin antigen [HA]), ID one-half dose (0.25 mL, 7.5 ±g HA) or intramuscular (IM) full-dose (0.5 mL, 15 ±g HA) vaccination. Immunogenicity was assessed up to six months after vaccination. F/U, follow-up.</p>
</caption>
<graphic xlink:href="cevr-2-115-g001"></graphic>
</fig>
<fig id="F2" orientation="portrait" position="float"><label>Fig. 2</label>
<caption><p>Geometric mean titer (GMT) fold-increases were assessed at 1 month post-vaccination (A) and 6 months post-vaccination (B), by hemagglutination inhibition assay.</p>
</caption>
<graphic xlink:href="cevr-2-115-g002"></graphic>
</fig>
<table-wrap id="T1" orientation="portrait" position="float"><label>Table 1</label>
<caption><p>Baseline characteristics of study subjects</p>
</caption>
<graphic xlink:href="cevr-2-115-i001"></graphic>
<table-wrap-foot><fn><p>Values are presented as mean±SD or n (%).</p>
<p>SD, standard deviation; BMI, body mass index.</p>
</fn>
</table-wrap-foot>
</table-wrap>
<table-wrap id="T2" orientation="portrait" position="float"><label>Table 2</label>
<caption><p>Comparison of short- and long-term immune responses after influenza vaccination, by hemagglutination inhibition assay</p>
</caption>
<graphic xlink:href="cevr-2-115-i002"></graphic>
<table-wrap-foot><fn><p>The same letters indicate non-significant differences between groups based on Tukey's multiple comparison tests.</p>
<p>The numbers in parentheses represent 95% confidence interval.</p>
</fn>
</table-wrap-foot>
</table-wrap>
</floats-group>
</pmc>
<affiliations><list><country><li>Corée du Sud</li>
</country>
<region><li>Région capitale de Séoul</li>
</region>
<settlement><li>Séoul</li>
</settlement>
</list>
<tree><country name="Corée du Sud"><region name="Région capitale de Séoul"><name sortKey="Song, Joon Young" sort="Song, Joon Young" uniqKey="Song J" first="Joon Young" last="Song">Joon Young Song</name>
</region>
<name sortKey="Cheong, Hee Jin" sort="Cheong, Hee Jin" uniqKey="Cheong H" first="Hee Jin" last="Cheong">Hee Jin Cheong</name>
<name sortKey="Cheong, Hee Jin" sort="Cheong, Hee Jin" uniqKey="Cheong H" first="Hee Jin" last="Cheong">Hee Jin Cheong</name>
<name sortKey="Choi, Won Suk" sort="Choi, Won Suk" uniqKey="Choi W" first="Won Suk" last="Choi">Won Suk Choi</name>
<name sortKey="Hong, Kyung Wook" sort="Hong, Kyung Wook" uniqKey="Hong K" first="Kyung-Wook" last="Hong">Kyung-Wook Hong</name>
<name sortKey="Kim, In Seon" sort="Kim, In Seon" uniqKey="Kim I" first="In Seon" last="Kim">In Seon Kim</name>
<name sortKey="Kim, Woo Joo" sort="Kim, Woo Joo" uniqKey="Kim W" first="Woo Joo" last="Kim">Woo Joo Kim</name>
<name sortKey="Kim, Woo Joo" sort="Kim, Woo Joo" uniqKey="Kim W" first="Woo Joo" last="Kim">Woo Joo Kim</name>
<name sortKey="Noh, Ji Yun" sort="Noh, Ji Yun" uniqKey="Noh J" first="Ji Yun" last="Noh">Ji Yun Noh</name>
<name sortKey="Noh, Ji Yun" sort="Noh, Ji Yun" uniqKey="Noh J" first="Ji Yun" last="Noh">Ji Yun Noh</name>
<name sortKey="Seo, Yu Bin" sort="Seo, Yu Bin" uniqKey="Seo Y" first="Yu Bin" last="Seo">Yu Bin Seo</name>
<name sortKey="Song, Joon Young" sort="Song, Joon Young" uniqKey="Song J" first="Joon Young" last="Song">Joon Young Song</name>
<name sortKey="Yang, Tae Un" sort="Yang, Tae Un" uniqKey="Yang T" first="Tae Un" last="Yang">Tae Un Yang</name>
</country>
</tree>
</affiliations>
</record>
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