PandemieGrippaleV1, PascalFrancis, Corpus, bibRecord, 000161

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 : 000161 ( PascalFrancis/Corpus ); précédent : 000160; suivant : 000162

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 ; Brandon Essink ; Steven Hull ; Steven Reed ; Ruvim Izikson ; Peter Patriarca ; Karen L. Goldenthal ; Robert Kohberger ; Lisa M. Dunkle

Source :

Vaccine [ 0264-410X ] ; 2013.

RBID : Pascal:14-0027942

Descripteurs français

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

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.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

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A11	`04`	`1`		`@1 REED (Steven)`
A11	`05`	`1`		`@1 IZIKSON (Ruvim)`
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A14	`01`			`@1 University of Rochester School of Medicine @2 Rochester, NY @3 USA @Z 1 aut.`
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A14	`04`			`@1 Immune Design Corporation @2 Seattle, WA @3 USA @Z 4 aut.`
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Format Inist (serveur)

NO :	PASCAL 14-0027942 INIST
ET :	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
AU :	TREANOR (John J.); ESSINK (Brandon); HULL (Steven); REED (Steven); IZIKSON (Ruvim); PATRIARCA (Peter); GOLDENTHAL (Karen L.); KOHBERGER (Robert); DUNKLE (Lisa M.)
AF :	University of Rochester School of Medicine/Rochester, NY/Etats-Unis (1 aut.); Meridian Clinical Research/Omaha, NE/Etats-Unis (2 aut.); Vince and Associates Clinical Research/Overland Park, KS/Etats-Unis (3 aut.); Immune Design Corporation/Seattle, WA/Etats-Unis (4 aut.); Protein Sciences Corporation/Meriden, CT/Etats-Unis (5 aut., 9 aut.); Biologies Consulting, Inc./Bethesda, MD/Etats-Unis (6 aut.); Independent Consultant/Bethesda, MD/Etats-Unis (7 aut.); Independent Consultant/Stamford, CT/Etats-Unis (8 aut.)
DT :	Publication en série; Niveau analytique
SO :	Vaccine; ISSN 0264-410X; Coden VACCDE; Royaume-Uni; Da. 2013; Vol. 31; No. 48; Pp. 5760-5765; Bibl. 28 ref.
LA :	Anglais
EA :	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.
CC :	002A05F04; 002A05C10
FD :	Influenzavirus aviaire; Immunogénicité; Hémagglutinine; Indonésie; Adjuvant immunologique; Vaccin; Grippe; Hémagglutinine H5
FG :	Influenzavirus A; Orthomyxoviridae; Virus; Asie; Asie du sud est; Virose; Infection; Zone tropicale; Zoopathogène
ED :	Avian influenzavirus; Immunogenicity; Hemagglutinin; Indonesia; Immunological adjuvant; Vaccine; Influenza
EG :	Influenzavirus A; Orthomyxoviridae; Virus; Asia; South east Asia; Viral disease; Infection; Tropical zone; Zoopathogen
SD :	Avian influenzavirus; Inmunogenicidad; Hemoaglutinina; Indonesia; Coadyuvante inmunológico; Vacuna; Gripe
LO :	INIST-20289.354000504267830200
ID :	14-0027942

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Pascal:14-0027942

Le document en format XML

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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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<fA08 i1="01" i2="1" l="ENG"><s1>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</s1>
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<fA11 i1="03" i2="1"><s1>HULL (Steven)</s1>
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<fA11 i1="04" i2="1"><s1>REED (Steven)</s1>
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<fA11 i1="05" i2="1"><s1>IZIKSON (Ruvim)</s1>
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<fA11 i1="06" i2="1"><s1>PATRIARCA (Peter)</s1>
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<fA11 i1="07" i2="1"><s1>GOLDENTHAL (Karen L.)</s1>
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<fA11 i1="08" i2="1"><s1>KOHBERGER (Robert)</s1>
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<fA11 i1="09" i2="1"><s1>DUNKLE (Lisa M.)</s1>
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<fA14 i1="01"><s1>University of Rochester School of Medicine</s1>
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<sZ>1 aut.</sZ>
</fA14>
<fA14 i1="02"><s1>Meridian Clinical Research</s1>
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<s3>USA</s3>
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<fA14 i1="03"><s1>Vince and Associates Clinical Research</s1>
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<sZ>3 aut.</sZ>
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<fA14 i1="04"><s1>Immune Design Corporation</s1>
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<fA14 i1="05"><s1>Protein Sciences Corporation</s1>
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<sZ>5 aut.</sZ>
<sZ>9 aut.</sZ>
</fA14>
<fA14 i1="06"><s1>Biologies Consulting, Inc.</s1>
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<s3>USA</s3>
<sZ>6 aut.</sZ>
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<fA14 i1="07"><s1>Independent Consultant</s1>
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<sZ>7 aut.</sZ>
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<fA14 i1="08"><s1>Independent Consultant</s1>
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<sZ>8 aut.</sZ>
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<fA20><s1>5760-5765</s1>
</fA20>
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<fA44><s0>0000</s0>
<s1>© 2014 INIST-CNRS. All rights reserved.</s1>
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<fA45><s0>28 ref.</s0>
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<fA47 i1="01" i2="1"><s0>14-0027942</s0>
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<fC01 i1="01" l="ENG"><s0>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.</s0>
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<fC07 i1="02" i2="X" l="SPA"><s0>Orthomyxoviridae</s0>
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<s2>NW</s2>
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<fC07 i1="06" i2="X" l="SPA"><s0>Virosis</s0>
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<server><NO>PASCAL 14-0027942 INIST</NO>
<ET>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</ET>
<AU>TREANOR (John J.); ESSINK (Brandon); HULL (Steven); REED (Steven); IZIKSON (Ruvim); PATRIARCA (Peter); GOLDENTHAL (Karen L.); KOHBERGER (Robert); DUNKLE (Lisa M.)</AU>
<AF>University of Rochester School of Medicine/Rochester, NY/Etats-Unis (1 aut.); Meridian Clinical Research/Omaha, NE/Etats-Unis (2 aut.); Vince and Associates Clinical Research/Overland Park, KS/Etats-Unis (3 aut.); Immune Design Corporation/Seattle, WA/Etats-Unis (4 aut.); Protein Sciences Corporation/Meriden, CT/Etats-Unis (5 aut., 9 aut.); Biologies Consulting, Inc./Bethesda, MD/Etats-Unis (6 aut.); Independent Consultant/Bethesda, MD/Etats-Unis (7 aut.); Independent Consultant/Stamford, CT/Etats-Unis (8 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Vaccine; ISSN 0264-410X; Coden VACCDE; Royaume-Uni; Da. 2013; Vol. 31; No. 48; Pp. 5760-5765; Bibl. 28 ref.</SO>
<LA>Anglais</LA>
<EA>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.</EA>
<CC>002A05F04; 002A05C10</CC>
<FD>Influenzavirus aviaire; Immunogénicité; Hémagglutinine; Indonésie; Adjuvant immunologique; Vaccin; Grippe; Hémagglutinine H5</FD>
<FG>Influenzavirus A; Orthomyxoviridae; Virus; Asie; Asie du sud est; Virose; Infection; Zone tropicale; Zoopathogène</FG>
<ED>Avian influenzavirus; Immunogenicity; Hemagglutinin; Indonesia; Immunological adjuvant; Vaccine; Influenza</ED>
<EG>Influenzavirus A; Orthomyxoviridae; Virus; Asia; South east Asia; Viral disease; Infection; Tropical zone; Zoopathogen</EG>
<SD>Avian influenzavirus; Inmunogenicidad; Hemoaglutinina; Indonesia; Coadyuvante inmunológico; Vacuna; Gripe</SD>
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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

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