Evaluation of safety and immunogenicity of recombinant influenza hemagglutinin (H5/Indonesia/05/2005) formulated with and without a stable oil-in-water emulsion containing glucopyranosyl-lipid A (SE + GLA) adjuvant
Identifieur interne : 001876 ( Main/Merge ); précédent : 001875; suivant : 001877Evaluation of safety and immunogenicity of recombinant influenza hemagglutinin (H5/Indonesia/05/2005) formulated with and without a stable oil-in-water emulsion containing glucopyranosyl-lipid A (SE + GLA) adjuvant
Auteurs : John J. Treanor [États-Unis] ; Brandon Essink [États-Unis] ; Steven Hull [États-Unis] ; Steven Reed [États-Unis] ; Ruvim Izikson [États-Unis] ; Peter Patriarca [États-Unis] ; Karen L. Goldenthal [États-Unis] ; Robert Kohberger [États-Unis] ; Lisa M. Dunkle [États-Unis]Source :
- Vaccine [ 0264-410X ] ; 2013.
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Abstract
Background: Expression of recombinant hemagglutinin (rHA) in insect cells represents a technology with proven efficacy in seasonal influenza and with the potential for a rapid response to the emergence of new, pandemic strains. We evaluated the safety and immunogenicity of rHA vaccine (H5/Indonesia/5/05) produced in SF+ insect cells using a baculovirus expression vector system (BEVS). The rHA vaccine was tested with and without the adjuvant glucopyranosyl lipid A/stable emulsion (GLA/SE). Methods: Healthy adults 18-49 were randomized to two IM doses on Days 0 and 21 of placebo; unadjuvanted rHA 135 μg or 45 μg, or rHA 45 μg, 15 μg, 7.5 μg or 3.8 μg with GLA/SE. A pioneer group was monitored through Day 42 before randomizing remaining subjects. H5-specific antibody was determined by hemagglutination inhibition (HAI) and microneutralization (MN) on Days 0, 21 and 42. Results: 392 subjects were randomized, of whom 380 (97%) received two doses and 386 (98%) completed 12 months of follow-up. Injection site pain and tenderness were seen in 50-70% of rHA + GLA/SE recipients and 4-9% of rHA alone and placebo recipients, but most complaints were mild to moderate in intensity. After two doses, the proportions of subjects with HAI titers ≥1:40 were 32% and 15% in the unadjuvanted 135 μg and 45 μg groups, and 82%, 75%, 66%, and 72% in those receiving 45 μg, 15 μg, 7.5 μg, or 3.8 μg with GLA/SE. The geometric mean titers (GMTs) of HAI antibody on Day 42 were 128, 95, 69, and 72 in the 45 μg, 15 μg, 7.5 μg, or 3.8 μg with GLA/SE groups, respectively. Conclusions: rHA GLA/SE was well tolerated and immunogenic in healthy adults, and GLA/SE substantially improved the serum antibody response. rHA expressed using BEVS recombinant DNA platform technology represents a promising strategy for pandemic control.
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<series><title level="j" type="main">Vaccine</title>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Avian influenzavirus</term>
<term>Hemagglutinin</term>
<term>Immunogenicity</term>
<term>Immunological adjuvant</term>
<term>Indonesia</term>
<term>Influenza</term>
<term>Vaccine</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Influenzavirus aviaire</term>
<term>Immunogénicité</term>
<term>Hémagglutinine</term>
<term>Indonésie</term>
<term>Adjuvant immunologique</term>
<term>Vaccin</term>
<term>Grippe</term>
<term>Hémagglutinine H5</term>
</keywords>
<keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>Indonésie</term>
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<front><div type="abstract" xml:lang="en">Background: Expression of recombinant hemagglutinin (rHA) in insect cells represents a technology with proven efficacy in seasonal influenza and with the potential for a rapid response to the emergence of new, pandemic strains. We evaluated the safety and immunogenicity of rHA vaccine (H5/Indonesia/5/05) produced in SF+ insect cells using a baculovirus expression vector system (BEVS). The rHA vaccine was tested with and without the adjuvant glucopyranosyl lipid A/stable emulsion (GLA/SE). Methods: Healthy adults 18-49 were randomized to two IM doses on Days 0 and 21 of placebo; unadjuvanted rHA 135 μg or 45 μg, or rHA 45 μg, 15 μg, 7.5 μg or 3.8 μg with GLA/SE. A pioneer group was monitored through Day 42 before randomizing remaining subjects. H5-specific antibody was determined by hemagglutination inhibition (HAI) and microneutralization (MN) on Days 0, 21 and 42. Results: 392 subjects were randomized, of whom 380 (97%) received two doses and 386 (98%) completed 12 months of follow-up. Injection site pain and tenderness were seen in 50-70% of rHA + GLA/SE recipients and 4-9% of rHA alone and placebo recipients, but most complaints were mild to moderate in intensity. After two doses, the proportions of subjects with HAI titers ≥1:40 were 32% and 15% in the unadjuvanted 135 μg and 45 μg groups, and 82%, 75%, 66%, and 72% in those receiving 45 μg, 15 μg, 7.5 μg, or 3.8 μg with GLA/SE. The geometric mean titers (GMTs) of HAI antibody on Day 42 were 128, 95, 69, and 72 in the 45 μg, 15 μg, 7.5 μg, or 3.8 μg with GLA/SE groups, respectively. Conclusions: rHA GLA/SE was well tolerated and immunogenic in healthy adults, and GLA/SE substantially improved the serum antibody response. rHA expressed using BEVS recombinant DNA platform technology represents a promising strategy for pandemic control.</div>
</front>
</TEI>
<affiliations><list><country><li>États-Unis</li>
</country>
<region><li>Connecticut</li>
<li>Kansas</li>
<li>Maryland</li>
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<tree><country name="États-Unis"><region name="État de New York"><name sortKey="Treanor, John J" sort="Treanor, John J" uniqKey="Treanor J" first="John J." last="Treanor">John J. Treanor</name>
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<name sortKey="Dunkle, Lisa M" sort="Dunkle, Lisa M" uniqKey="Dunkle L" first="Lisa M." last="Dunkle">Lisa M. Dunkle</name>
<name sortKey="Essink, Brandon" sort="Essink, Brandon" uniqKey="Essink B" first="Brandon" last="Essink">Brandon Essink</name>
<name sortKey="Goldenthal, Karen L" sort="Goldenthal, Karen L" uniqKey="Goldenthal K" first="Karen L." last="Goldenthal">Karen L. Goldenthal</name>
<name sortKey="Hull, Steven" sort="Hull, Steven" uniqKey="Hull S" first="Steven" last="Hull">Steven Hull</name>
<name sortKey="Izikson, Ruvim" sort="Izikson, Ruvim" uniqKey="Izikson R" first="Ruvim" last="Izikson">Ruvim Izikson</name>
<name sortKey="Kohberger, Robert" sort="Kohberger, Robert" uniqKey="Kohberger R" first="Robert" last="Kohberger">Robert Kohberger</name>
<name sortKey="Patriarca, Peter" sort="Patriarca, Peter" uniqKey="Patriarca P" first="Peter" last="Patriarca">Peter Patriarca</name>
<name sortKey="Reed, Steven" sort="Reed, Steven" uniqKey="Reed S" first="Steven" last="Reed">Steven Reed</name>
</country>
</tree>
</affiliations>
</record>
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