Safety and Immunogenicity of an Inactivated Influenza A/H5N1 Vaccine Given with or without Aluminum Hydroxide to Healthy Adults: Results of a Phase I–II Randomized Clinical Trial
Identifieur interne : 001291 ( Main/Exploration ); précédent : 001290; suivant : 001292Safety and Immunogenicity of an Inactivated Influenza A/H5N1 Vaccine Given with or without Aluminum Hydroxide to Healthy Adults: Results of a Phase I–II Randomized Clinical Trial
Auteurs : Wendy A. Keitel [États-Unis] ; James D. Campbell [États-Unis] ; John J. Treanor [États-Unis] ; Emmanuel B. Walter [États-Unis] ; Shital M. Patel [États-Unis] ; Fenhua He [États-Unis] ; Diana L. Noah [États-Unis] ; Heather Hill [États-Unis]Source :
- Journal of Infectious Diseases [ 0022-1899 ] ; 2008.
Abstract
Background. Dose-sparing strategies are being explored for vaccines against pandemic influenza. We evaluated the dose-sparing potential of aluminum hydroxide (AlOH) adjuvant. Methods. A total of 600 healthy subjects (age, 18–49 years) were randomized to receive 2 vaccinations 1 month apart with subvirion inactivated influenza A/H5N1 vaccine containing 7.5, 15, or 45 µg of hemagglutinin (HA), with or without 600 µg of aluminum hydroxide (AlOH), or 3.75 µg of HA, with or without 300 µg of AlOH. Serum specimens were obtained for antibody assays before and 1 month after each vaccination. Results. All formulations were safe. Injection site discomfort was more frequent in groups given vaccines with AlOH. Dose-related increases in antibody responses were noted after both vaccinations (P < .001): geometric mean titers of hemagglutination inhibition antibody in vaccines with and without AlOH, respectively, were 5.4 and 5.4 for subjects who received 3.75 µg of HA, 7.7 and 5.3 for those who received 7.5 µg of HA, 8.1 and 8.5 for those who received 15 µg of HA, and 14.8 and 12 for those who received 45 µg of HA. A ⩾4-fold increase in titer was observed in 2% and 2% of subjects who received 3.75 µg of HA with or without AlOH, respectively; in 14% and 0% who received 7 µg of HA; in 14% and 13% who received 15 µg of HA; and in 33% and 25% who received 45 µg of HA. Addition of AlOH enhanced responses only for subjects who received 7.5 µg of HA, but responses in subjects who received 7.5 µg of HA without AlOH were unexpectedly low. Conclusion. Overall, a meaningful beneficial effect of AlOH adjuvant was not observed. Trial registration. ClinicalTrials.gov identifier: NCT00296634.
Url:
DOI: 10.1086/592172
Affiliations:
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Keitel</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Texas</region></placeName><wicri:cityArea>Baylor College of Medicine, Houston</wicri:cityArea></affiliation><affiliation wicri:level="1"><country wicri:rule="url">États-Unis</country></affiliation><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Texas</region></placeName><wicri:cityArea>Reprints or correspondence: Dr. Wendy A. Keitel, Baylor College of Medicine 280, One Baylor Plz., Houston</wicri:cityArea></affiliation></author><author><name sortKey="Campbell, James D" sort="Campbell, James D" uniqKey="Campbell J" first="James D." last="Campbell">James D. Campbell</name><affiliation wicri:level="3"><country>États-Unis</country><placeName><settlement type="city">Baltimore</settlement><region type="state">Maryland</region></placeName><wicri:orgArea>University of Maryland School of Medicine</wicri:orgArea></affiliation></author><author><name sortKey="Treanor, John J" sort="Treanor, John J" uniqKey="Treanor J" first="John J." last="Treanor">John J. Treanor</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">État de New York</region></placeName><wicri:cityArea>University of Rochester, Rochester</wicri:cityArea></affiliation></author><author><name sortKey="Walter, Emmanuel B" sort="Walter, Emmanuel B" uniqKey="Walter E" first="Emmanuel B." last="Walter">Emmanuel B. Walter</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName><wicri:cityArea>Duke University Medical Center, Durham</wicri:cityArea></affiliation></author><author><name sortKey="Patel, Shital M" sort="Patel, Shital M" uniqKey="Patel S" first="Shital M." last="Patel">Shital M. Patel</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Texas</region></placeName><wicri:cityArea>Baylor College of Medicine, Houston</wicri:cityArea></affiliation></author><author><name sortKey="He, Fenhua" sort="He, Fenhua" uniqKey="He F" first="Fenhua" last="He">Fenhua He</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Maryland</region></placeName><wicri:cityArea>The EMMES Corporation, Rockville</wicri:cityArea></affiliation></author><author><name sortKey="Noah, Diana L" sort="Noah, Diana L" uniqKey="Noah D" first="Diana L." last="Noah">Diana L. Noah</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Alabama</region></placeName><wicri:cityArea>Southern Research Institute, Birmingham</wicri:cityArea></affiliation></author><author><name sortKey="Hill, Heather" sort="Hill, Heather" uniqKey="Hill H" first="Heather" last="Hill">Heather Hill</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Maryland</region></placeName><wicri:cityArea>The EMMES Corporation, Rockville</wicri:cityArea></affiliation></author></analytic><monogr></monogr><series><title level="j" type="main">Journal of Infectious Diseases</title><title level="j" type="abbrev">Journal of Infectious Diseases</title><idno type="ISSN">0022-1899</idno><idno type="eISSN">1537-6613</idno><imprint><publisher>The University of Chicago Press</publisher><date when="2008-11-01">2008</date><biblScope unit="vol">198</biblScope><biblScope unit="issue">9</biblScope><biblScope unit="page" from="1309">1309</biblScope><biblScope unit="page" to="1316">1316</biblScope></imprint><idno type="ISSN">0022-1899</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0022-1899</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract">Background. Dose-sparing strategies are being explored for vaccines against pandemic influenza. We evaluated the dose-sparing potential of aluminum hydroxide (AlOH) adjuvant. Methods. A total of 600 healthy subjects (age, 18–49 years) were randomized to receive 2 vaccinations 1 month apart with subvirion inactivated influenza A/H5N1 vaccine containing 7.5, 15, or 45 µg of hemagglutinin (HA), with or without 600 µg of aluminum hydroxide (AlOH), or 3.75 µg of HA, with or without 300 µg of AlOH. Serum specimens were obtained for antibody assays before and 1 month after each vaccination. Results. All formulations were safe. Injection site discomfort was more frequent in groups given vaccines with AlOH. Dose-related increases in antibody responses were noted after both vaccinations (P < .001): geometric mean titers of hemagglutination inhibition antibody in vaccines with and without AlOH, respectively, were 5.4 and 5.4 for subjects who received 3.75 µg of HA, 7.7 and 5.3 for those who received 7.5 µg of HA, 8.1 and 8.5 for those who received 15 µg of HA, and 14.8 and 12 for those who received 45 µg of HA. A ⩾4-fold increase in titer was observed in 2% and 2% of subjects who received 3.75 µg of HA with or without AlOH, respectively; in 14% and 0% who received 7 µg of HA; in 14% and 13% who received 15 µg of HA; and in 33% and 25% who received 45 µg of HA. Addition of AlOH enhanced responses only for subjects who received 7.5 µg of HA, but responses in subjects who received 7.5 µg of HA without AlOH were unexpectedly low. Conclusion. Overall, a meaningful beneficial effect of AlOH adjuvant was not observed. Trial registration. ClinicalTrials.gov identifier: NCT00296634.</div></front></TEI><affiliations><list><country><li>États-Unis</li></country><region><li>Alabama</li><li>Caroline du Nord</li><li>Maryland</li><li>Texas</li><li>État de New York</li></region><settlement><li>Baltimore</li></settlement></list><tree><country name="États-Unis"><region name="Texas"><name sortKey="Keitel, Wendy A" sort="Keitel, Wendy A" uniqKey="Keitel W" first="Wendy A." last="Keitel">Wendy A. Keitel</name></region><name sortKey="Campbell, James D" sort="Campbell, James D" uniqKey="Campbell J" first="James D." last="Campbell">James D. Campbell</name><name sortKey="He, Fenhua" sort="He, Fenhua" uniqKey="He F" first="Fenhua" last="He">Fenhua He</name><name sortKey="Hill, Heather" sort="Hill, Heather" uniqKey="Hill H" first="Heather" last="Hill">Heather Hill</name><name sortKey="Keitel, Wendy A" sort="Keitel, Wendy A" uniqKey="Keitel W" first="Wendy A." last="Keitel">Wendy A. Keitel</name><name sortKey="Keitel, Wendy A" sort="Keitel, Wendy A" uniqKey="Keitel W" first="Wendy A." last="Keitel">Wendy A. Keitel</name><name sortKey="Noah, Diana L" sort="Noah, Diana L" uniqKey="Noah D" first="Diana L." last="Noah">Diana L. Noah</name><name sortKey="Patel, Shital M" sort="Patel, Shital M" uniqKey="Patel S" first="Shital M." last="Patel">Shital M. Patel</name><name sortKey="Treanor, John J" sort="Treanor, John J" uniqKey="Treanor J" first="John J." last="Treanor">John J. Treanor</name><name sortKey="Walter, Emmanuel B" sort="Walter, Emmanuel B" uniqKey="Walter E" first="Emmanuel B." last="Walter">Emmanuel B. Walter</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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