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 : 000279 ( PascalFrancis/Checkpoint ); précédent : 000278; suivant : 000280Evaluation 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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English descriptors
- KwdEn :
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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<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>
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<s5>07</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE"><s0>Adjuvant immunologique</s0>
<s5>08</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG"><s0>Immunological adjuvant</s0>
<s5>08</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Coadyuvante inmunológico</s0>
<s5>08</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Vaccin</s0>
<s5>09</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Vaccine</s0>
<s5>09</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Vacuna</s0>
<s5>09</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Grippe</s0>
<s5>14</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Influenza</s0>
<s5>14</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Gripe</s0>
<s5>14</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE"><s0>Hémagglutinine H5</s0>
<s4>INC</s4>
<s5>86</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Influenzavirus A</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Influenzavirus A</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Influenzavirus A</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="02" i2="X" l="FRE"><s0>Orthomyxoviridae</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Orthomyxoviridae</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Orthomyxoviridae</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="03" i2="X" l="FRE"><s0>Virus</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="03" i2="X" l="ENG"><s0>Virus</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="03" i2="X" l="SPA"><s0>Virus</s0>
<s2>NW</s2>
</fC07>
<fC07 i1="04" i2="X" l="FRE"><s0>Asie</s0>
<s2>NG</s2>
</fC07>
<fC07 i1="04" i2="X" l="ENG"><s0>Asia</s0>
<s2>NG</s2>
</fC07>
<fC07 i1="04" i2="X" l="SPA"><s0>Asia</s0>
<s2>NG</s2>
</fC07>
<fC07 i1="05" i2="X" l="FRE"><s0>Asie du sud est</s0>
<s2>NG</s2>
<s5>13</s5>
</fC07>
<fC07 i1="05" i2="X" l="ENG"><s0>South east Asia</s0>
<s2>NG</s2>
<s5>13</s5>
</fC07>
<fC07 i1="05" i2="X" l="SPA"><s0>Asia del sureste</s0>
<s2>NG</s2>
<s5>13</s5>
</fC07>
<fC07 i1="06" i2="X" l="FRE"><s0>Virose</s0>
</fC07>
<fC07 i1="06" i2="X" l="ENG"><s0>Viral disease</s0>
</fC07>
<fC07 i1="06" i2="X" l="SPA"><s0>Virosis</s0>
</fC07>
<fC07 i1="07" i2="X" l="FRE"><s0>Infection</s0>
</fC07>
<fC07 i1="07" i2="X" l="ENG"><s0>Infection</s0>
</fC07>
<fC07 i1="07" i2="X" l="SPA"><s0>Infección</s0>
</fC07>
<fC07 i1="08" i2="X" l="FRE"><s0>Zone tropicale</s0>
<s5>16</s5>
</fC07>
<fC07 i1="08" i2="X" l="ENG"><s0>Tropical zone</s0>
<s5>16</s5>
</fC07>
<fC07 i1="08" i2="X" l="SPA"><s0>Zona tropical</s0>
<s5>16</s5>
</fC07>
<fC07 i1="09" i2="X" l="FRE"><s0>Zoopathogène</s0>
<s5>17</s5>
</fC07>
<fC07 i1="09" i2="X" l="ENG"><s0>Zoopathogen</s0>
<s5>17</s5>
</fC07>
<fC07 i1="09" i2="X" l="SPA"><s0>Zoopatógeno</s0>
<s5>17</s5>
</fC07>
<fN21><s1>027</s1>
</fN21>
</pA>
</standard>
</inist>
<affiliations><list><country><li>États-Unis</li>
</country>
<region><li>Connecticut</li>
<li>Kansas</li>
<li>Maryland</li>
<li>Nebraska</li>
<li>Washington (État)</li>
<li>État de New York</li>
</region>
</list>
<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>
</region>
<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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