PandemieGrippaleV1, Main, Exploration, bibRecord, 001848

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 : 001848 ( Main/Exploration ); précédent : 001847; suivant : 001849

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

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.

RBID : Pascal:14-0027942

Descripteurs français

Pascal (Inist)
- Influenzavirus aviaire, Immunogénicité, Hémagglutinine, Indonésie, Adjuvant immunologique, Vaccin, Grippe, Hémagglutinine H5.
Wicri :
- geographic : Indonésie.
- topic : Vaccin.

English descriptors

KwdEn :
- Avian influenzavirus, Hemagglutinin, Immunogenicity, Immunological adjuvant, Indonesia, Influenza, Vaccine.

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.

Affiliations:

Links toward previous steps (curation, corpus...)

to stream PascalFrancis, to step Corpus: 000161
to stream PascalFrancis, to step Curation: 001C57
to stream PascalFrancis, to step Checkpoint: 000279
to stream Main, to step Merge: 001876
to stream Main, to step Curation: 001848

Le document en format XML

<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">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</title>
<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"><inist:fA14 i1="01"><s1>University of Rochester School of Medicine</s1>
<s2>Rochester, NY</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">État de New York</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Essink, Brandon" sort="Essink, Brandon" uniqKey="Essink B" first="Brandon" last="Essink">Brandon Essink</name>
<affiliation wicri:level="2"><inist:fA14 i1="02"><s1>Meridian Clinical Research</s1>
<s2>Omaha, NE</s2>
<s3>USA</s3>
<sZ>2 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Nebraska</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Hull, Steven" sort="Hull, Steven" uniqKey="Hull S" first="Steven" last="Hull">Steven Hull</name>
<affiliation wicri:level="2"><inist:fA14 i1="03"><s1>Vince and Associates Clinical Research</s1>
<s2>Overland Park, KS</s2>
<s3>USA</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Kansas</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Reed, Steven" sort="Reed, Steven" uniqKey="Reed S" first="Steven" last="Reed">Steven Reed</name>
<affiliation wicri:level="2"><inist:fA14 i1="04"><s1>Immune Design Corporation</s1>
<s2>Seattle, WA</s2>
<s3>USA</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Washington (État)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Izikson, Ruvim" sort="Izikson, Ruvim" uniqKey="Izikson R" first="Ruvim" last="Izikson">Ruvim Izikson</name>
<affiliation wicri:level="2"><inist:fA14 i1="05"><s1>Protein Sciences Corporation</s1>
<s2>Meriden, CT</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
<sZ>9 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Connecticut</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Patriarca, Peter" sort="Patriarca, Peter" uniqKey="Patriarca P" first="Peter" last="Patriarca">Peter Patriarca</name>
<affiliation wicri:level="2"><inist:fA14 i1="06"><s1>Biologies Consulting, Inc.</s1>
<s2>Bethesda, MD</s2>
<s3>USA</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Maryland</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Goldenthal, Karen L" sort="Goldenthal, Karen L" uniqKey="Goldenthal K" first="Karen L." last="Goldenthal">Karen L. Goldenthal</name>
<affiliation wicri:level="2"><inist:fA14 i1="07"><s1>Independent Consultant</s1>
<s2>Bethesda, MD</s2>
<s3>USA</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Maryland</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Kohberger, Robert" sort="Kohberger, Robert" uniqKey="Kohberger R" first="Robert" last="Kohberger">Robert Kohberger</name>
<affiliation wicri:level="2"><inist:fA14 i1="08"><s1>Independent Consultant</s1>
<s2>Stamford, CT</s2>
<s3>USA</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Connecticut</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Dunkle, Lisa M" sort="Dunkle, Lisa M" uniqKey="Dunkle L" first="Lisa M." last="Dunkle">Lisa M. Dunkle</name>
<affiliation wicri:level="2"><inist:fA14 i1="05"><s1>Protein Sciences Corporation</s1>
<s2>Meriden, CT</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
<sZ>9 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Connecticut</region>
</placeName>
</affiliation>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">INIST</idno>
<idno type="inist">14-0027942</idno>
<date when="2013">2013</date>
<idno type="stanalyst">PASCAL 14-0027942 INIST</idno>
<idno type="RBID">Pascal:14-0027942</idno>
<idno type="wicri:Area/PascalFrancis/Corpus">000161</idno>
<idno type="wicri:Area/PascalFrancis/Curation">001C57</idno>
<idno type="wicri:Area/PascalFrancis/Checkpoint">000279</idno>
<idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">000279</idno>
<idno type="wicri:doubleKey">0264-410X:2013:Treanor J:evaluation:of:safety</idno>
<idno type="wicri:Area/Main/Merge">001876</idno>
<idno type="wicri:Area/Main/Curation">001848</idno>
<idno type="wicri:Area/Main/Exploration">001848</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">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</title>
<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"><inist:fA14 i1="01"><s1>University of Rochester School of Medicine</s1>
<s2>Rochester, NY</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">État de New York</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Essink, Brandon" sort="Essink, Brandon" uniqKey="Essink B" first="Brandon" last="Essink">Brandon Essink</name>
<affiliation wicri:level="2"><inist:fA14 i1="02"><s1>Meridian Clinical Research</s1>
<s2>Omaha, NE</s2>
<s3>USA</s3>
<sZ>2 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Nebraska</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Hull, Steven" sort="Hull, Steven" uniqKey="Hull S" first="Steven" last="Hull">Steven Hull</name>
<affiliation wicri:level="2"><inist:fA14 i1="03"><s1>Vince and Associates Clinical Research</s1>
<s2>Overland Park, KS</s2>
<s3>USA</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Kansas</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Reed, Steven" sort="Reed, Steven" uniqKey="Reed S" first="Steven" last="Reed">Steven Reed</name>
<affiliation wicri:level="2"><inist:fA14 i1="04"><s1>Immune Design Corporation</s1>
<s2>Seattle, WA</s2>
<s3>USA</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Washington (État)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Izikson, Ruvim" sort="Izikson, Ruvim" uniqKey="Izikson R" first="Ruvim" last="Izikson">Ruvim Izikson</name>
<affiliation wicri:level="2"><inist:fA14 i1="05"><s1>Protein Sciences Corporation</s1>
<s2>Meriden, CT</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
<sZ>9 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Connecticut</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Patriarca, Peter" sort="Patriarca, Peter" uniqKey="Patriarca P" first="Peter" last="Patriarca">Peter Patriarca</name>
<affiliation wicri:level="2"><inist:fA14 i1="06"><s1>Biologies Consulting, Inc.</s1>
<s2>Bethesda, MD</s2>
<s3>USA</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Maryland</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Goldenthal, Karen L" sort="Goldenthal, Karen L" uniqKey="Goldenthal K" first="Karen L." last="Goldenthal">Karen L. Goldenthal</name>
<affiliation wicri:level="2"><inist:fA14 i1="07"><s1>Independent Consultant</s1>
<s2>Bethesda, MD</s2>
<s3>USA</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Maryland</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Kohberger, Robert" sort="Kohberger, Robert" uniqKey="Kohberger R" first="Robert" last="Kohberger">Robert Kohberger</name>
<affiliation wicri:level="2"><inist:fA14 i1="08"><s1>Independent Consultant</s1>
<s2>Stamford, CT</s2>
<s3>USA</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Connecticut</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Dunkle, Lisa M" sort="Dunkle, Lisa M" uniqKey="Dunkle L" first="Lisa M." last="Dunkle">Lisa M. Dunkle</name>
<affiliation wicri:level="2"><inist:fA14 i1="05"><s1>Protein Sciences Corporation</s1>
<s2>Meriden, CT</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
<sZ>9 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Connecticut</region>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">Vaccine</title>
<title level="j" type="abbreviated">Vaccine</title>
<idno type="ISSN">0264-410X</idno>
<imprint><date when="2013">2013</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">Vaccine</title>
<title level="j" type="abbreviated">Vaccine</title>
<idno type="ISSN">0264-410X</idno>
</seriesStmt>
</fileDesc>
<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>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Vaccin</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<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>
<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>

Pour manipuler ce document sous Unix (Dilib)

EXPLOR_STEP=$WICRI_ROOT/Sante/explor/PandemieGrippaleV1/Data/Main/Exploration

HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 001848 | SxmlIndent | more

HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 001848 | SxmlIndent | more

Pour mettre un lien sur cette page dans le réseau Wicri

{{Explor lien
   |wiki=    Sante
   |area=    PandemieGrippaleV1
   |flux=    Main
   |étape=   Exploration
   |type=    RBID
   |clé=     Pascal:14-0027942
   |texte=   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
}}

This area was generated with Dilib version V0.6.34.
Data generation: Wed Jun 10 11:04:28 2020. Site generation: Sun Mar 28 09:10:28 2021

	Serveur d'exploration sur les pandémies grippales
	Attention, ce site est en cours de développement ! Attention, site généré par des moyens informatiques à partir de corpus bruts. Les informations ne sont donc pas validées.

Serveur d'exploration sur les pandémies grippales

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

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

Source :

Descripteurs français

English descriptors

Abstract

Links toward previous steps (curation, corpus...)

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

Pour mettre un lien sur cette page dans le réseau Wicri