Intranasal seasonal influenza vaccine and a TLR-3 agonist, rintatolimod, induced cross-reactive IgA antibody formation against avian H5N1 and H7N9 influenza HA in humans
Identifieur interne : 000080 ( PascalFrancis/Checkpoint ); précédent : 000079; suivant : 000081Intranasal seasonal influenza vaccine and a TLR-3 agonist, rintatolimod, induced cross-reactive IgA antibody formation against avian H5N1 and H7N9 influenza HA in humans
Auteurs : Edgar Turner Overton [États-Unis] ; Paul A. Goepfert [États-Unis] ; Pamela Cunningham [États-Unis] ; William A. Carter [États-Unis] ; Joseph Horvath [États-Unis] ; Diane Young [États-Unis] ; David R. Strayer [États-Unis]Source :
- Vaccine [ 0264-410X ] ; 2014.
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Abstract
The intranasal use of rintatolimod, a specific TLR-3 agonist, combined with trivalent seasonal influenza vaccine generated cross-protection against highly pathogenic H5N1 avian influenza in mice. The purpose of this clinical trial is to assess the safety and impact of rintatolimod on intranasal influenza vaccine in healthy adults. During Stage I of this Phase I/II clinical trial, 12 volunteers were immunized intranasally with 3 doses of FluMist® seasonal influenza vaccine on Days 0, 28, and 56 followed by intranasal rintatolimod (50 μg, 200 μg, or 500 μg) 3 days later. Parotid saliva and nasal wash samples were collected at baseline and on Days 25, 53, 84, and 417. The samples were tested for IgA and IgG specific antibodies (Ab) directed against the homologous FluMist® viral hemagglutinins (HAs). In addition, viral specific responses against influenza A HAs were tested for IgA Ab cross-reactivity against 3 H5 clades: HA (H5N1) A/Indonesia/5/2005, HA (H5N1) A/Hong Kong/483/97 and HA (H5N1) A/Vietnam/1194/2004, as well as, two H7 strains, HA (H7N9) A/Shanghai/2/2013 and HA (H7N3) A/chicken/Jalisco/CPA1. The combination of the intranasal FluMist® along with the rintatolimod generated specific secretory IgA responses of at least 4-fold over baseline against at least one of the homologous vaccine strains included in the vaccine in 92% of the vaccinees. Additionally, this vaccination strategy induced cross-reactive secretory IgA against highly pathogenic avian influenza virus strains H5N1, H7N9, and H7N3 with pandemic potential for humans. The combination of rintatolimod and FluMist® was well-tolerated.
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Goepfert</name><affiliation wicri:level="2"><inist:fA14 i1="01"><s1>University of Alabama at Birmingham, 908 20th Street South</s1><s2>Birmingham, AL 35294</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>3 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Alabama</region></placeName></affiliation></author><author><name sortKey="Cunningham, Pamela" sort="Cunningham, Pamela" uniqKey="Cunningham P" first="Pamela" last="Cunningham">Pamela Cunningham</name><affiliation wicri:level="2"><inist:fA14 i1="01"><s1>University of Alabama at Birmingham, 908 20th Street South</s1><s2>Birmingham, AL 35294</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>3 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Alabama</region></placeName></affiliation></author><author><name sortKey="Carter, William A" sort="Carter, William A" uniqKey="Carter W" first="William A." last="Carter">William A. Carter</name><affiliation wicri:level="2"><inist:fA14 i1="02"><s1>Hemispherx Biopharma, Inc., One Penn Center, 1617JFK Boulevard, Suite 500</s1><s2>Philadelphia, PA 19103</s2><s3>USA</s3><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>7 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Horvath, Joseph" sort="Horvath, Joseph" uniqKey="Horvath J" first="Joseph" last="Horvath">Joseph Horvath</name><affiliation wicri:level="2"><inist:fA14 i1="02"><s1>Hemispherx Biopharma, Inc., One Penn Center, 1617JFK Boulevard, Suite 500</s1><s2>Philadelphia, PA 19103</s2><s3>USA</s3><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>7 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Young, Diane" sort="Young, Diane" uniqKey="Young D" first="Diane" last="Young">Diane Young</name><affiliation wicri:level="2"><inist:fA14 i1="02"><s1>Hemispherx Biopharma, Inc., One Penn Center, 1617JFK Boulevard, Suite 500</s1><s2>Philadelphia, PA 19103</s2><s3>USA</s3><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>7 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName></affiliation></author><author><name sortKey="Strayer, David R" sort="Strayer, David R" uniqKey="Strayer D" first="David R." last="Strayer">David R. Strayer</name><affiliation wicri:level="2"><inist:fA14 i1="02"><s1>Hemispherx Biopharma, Inc., One Penn Center, 1617JFK Boulevard, Suite 500</s1><s2>Philadelphia, PA 19103</s2><s3>USA</s3><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>7 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Pennsylvanie</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="2014">2014</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>Antibody</term><term>Attenuated strain</term><term>Avian influenza</term><term>Human</term><term>IgA</term><term>Immunological adjuvant</term><term>Influenza A</term><term>Influenza A virus</term><term>Intranasal administration</term><term>Mucosa</term><term>Vaccine</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Virus grippal A</term><term>Homme</term><term>Voie intranasale</term><term>Vaccin</term><term>IgA</term><term>Anticorps</term><term>Souche atténuée</term><term>Adjuvant immunologique</term><term>Muqueuse</term><term>Grippe A</term><term>Grippe aviaire</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term><term>Vaccin</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The intranasal use of rintatolimod, a specific TLR-3 agonist, combined with trivalent seasonal influenza vaccine generated cross-protection against highly pathogenic H5N1 avian influenza in mice. The purpose of this clinical trial is to assess the safety and impact of rintatolimod on intranasal influenza vaccine in healthy adults. During Stage I of this Phase I/II clinical trial, 12 volunteers were immunized intranasally with 3 doses of FluMist® seasonal influenza vaccine on Days 0, 28, and 56 followed by intranasal rintatolimod (50 μg, 200 μg, or 500 μg) 3 days later. Parotid saliva and nasal wash samples were collected at baseline and on Days 25, 53, 84, and 417. The samples were tested for IgA and IgG specific antibodies (Ab) directed against the homologous FluMist® viral hemagglutinins (HAs). In addition, viral specific responses against influenza A HAs were tested for IgA Ab cross-reactivity against 3 H5 clades: HA (H5N1) A/Indonesia/5/2005, HA (H5N1) A/Hong Kong/483/97 and HA (H5N1) A/Vietnam/1194/2004, as well as, two H7 strains, HA (H7N9) A/Shanghai/2/2013 and HA (H7N3) A/chicken/Jalisco/CPA1. The combination of the intranasal FluMist® along with the rintatolimod generated specific secretory IgA responses of at least 4-fold over baseline against at least one of the homologous vaccine strains included in the vaccine in 92% of the vaccinees. Additionally, this vaccination strategy induced cross-reactive secretory IgA against highly pathogenic avian influenza virus strains H5N1, H7N9, and H7N3 with pandemic potential for humans. The combination of rintatolimod and FluMist® was well-tolerated.</div></front></TEI><inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0264-410X</s0></fA01><fA02 i1="01"><s0>VACCDE</s0></fA02><fA03 i2="1"><s0>Vaccine</s0></fA03><fA05><s2>32</s2></fA05><fA06><s2>42</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>Intranasal seasonal influenza vaccine and a TLR-3 agonist, rintatolimod, induced cross-reactive IgA antibody formation against avian H5N1 and H7N9 influenza HA in humans</s1></fA08><fA11 i1="01" i2="1"><s1>OVERTON (Edgar Turner)</s1></fA11><fA11 i1="02" i2="1"><s1>GOEPFERT (Paul A.)</s1></fA11><fA11 i1="03" i2="1"><s1>CUNNINGHAM (Pamela)</s1></fA11><fA11 i1="04" i2="1"><s1>CARTER (William A.)</s1></fA11><fA11 i1="05" i2="1"><s1>HORVATH (Joseph)</s1></fA11><fA11 i1="06" i2="1"><s1>YOUNG (Diane)</s1></fA11><fA11 i1="07" i2="1"><s1>STRAYER (David R.)</s1></fA11><fA14 i1="01"><s1>University of Alabama at Birmingham, 908 20th Street South</s1><s2>Birmingham, AL 35294</s2><s3>USA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>3 aut.</sZ></fA14><fA14 i1="02"><s1>Hemispherx Biopharma, Inc., One Penn Center, 1617JFK Boulevard, Suite 500</s1><s2>Philadelphia, PA 19103</s2><s3>USA</s3><sZ>4 aut.</sZ><sZ>5 aut.</sZ><sZ>6 aut.</sZ><sZ>7 aut.</sZ></fA14><fA20><s1>5490-5495</s1></fA20><fA21><s1>2014</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>20289</s2><s5>354000504533570190</s5></fA43><fA44><s0>0000</s0><s1>© 2014 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>19 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>14-0246270</s0></fA47><fA60><s1>P</s1></fA60><fA61><s0>A</s0></fA61><fA64 i1="01" i2="1"><s0>Vaccine</s0></fA64><fA66 i1="01"><s0>GBR</s0></fA66><fC01 i1="01" l="ENG"><s0>The intranasal use of rintatolimod, a specific TLR-3 agonist, combined with trivalent seasonal influenza vaccine generated cross-protection against highly pathogenic H5N1 avian influenza in mice. The purpose of this clinical trial is to assess the safety and impact of rintatolimod on intranasal influenza vaccine in healthy adults. During Stage I of this Phase I/II clinical trial, 12 volunteers were immunized intranasally with 3 doses of FluMist® seasonal influenza vaccine on Days 0, 28, and 56 followed by intranasal rintatolimod (50 μg, 200 μg, or 500 μg) 3 days later. Parotid saliva and nasal wash samples were collected at baseline and on Days 25, 53, 84, and 417. The samples were tested for IgA and IgG specific antibodies (Ab) directed against the homologous FluMist® viral hemagglutinins (HAs). In addition, viral specific responses against influenza A HAs were tested for IgA Ab cross-reactivity against 3 H5 clades: HA (H5N1) A/Indonesia/5/2005, HA (H5N1) A/Hong Kong/483/97 and HA (H5N1) A/Vietnam/1194/2004, as well as, two H7 strains, HA (H7N9) A/Shanghai/2/2013 and HA (H7N3) A/chicken/Jalisco/CPA1. The combination of the intranasal FluMist® along with the rintatolimod generated specific secretory IgA responses of at least 4-fold over baseline against at least one of the homologous vaccine strains included in the vaccine in 92% of the vaccinees. Additionally, this vaccination strategy induced cross-reactive secretory IgA against highly pathogenic avian influenza virus strains H5N1, H7N9, and H7N3 with pandemic potential for humans. The combination of rintatolimod and FluMist® was well-tolerated.</s0></fC01><fC02 i1="01" i2="X"><s0>002A05F04</s0></fC02><fC02 i1="02" i2="X"><s0>002A05C10</s0></fC02><fC03 i1="01" i2="X" l="FRE"><s0>Virus grippal A</s0><s2>NW</s2><s5>01</s5></fC03><fC03 i1="01" i2="X" l="ENG"><s0>Influenza A virus</s0><s2>NW</s2><s5>01</s5></fC03><fC03 i1="01" i2="X" l="SPA"><s0>Influenza A virus</s0><s2>NW</s2><s5>01</s5></fC03><fC03 i1="02" i2="X" l="FRE"><s0>Homme</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="ENG"><s0>Human</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="SPA"><s0>Hombre</s0><s5>02</s5></fC03><fC03 i1="03" i2="X" l="FRE"><s0>Voie intranasale</s0><s5>05</s5></fC03><fC03 i1="03" i2="X" l="ENG"><s0>Intranasal administration</s0><s5>05</s5></fC03><fC03 i1="03" i2="X" l="SPA"><s0>Vía intranasal</s0><s5>05</s5></fC03><fC03 i1="04" i2="X" l="FRE"><s0>Vaccin</s0><s5>06</s5></fC03><fC03 i1="04" i2="X" l="ENG"><s0>Vaccine</s0><s5>06</s5></fC03><fC03 i1="04" i2="X" l="SPA"><s0>Vacuna</s0><s5>06</s5></fC03><fC03 i1="05" i2="X" l="FRE"><s0>IgA</s0><s5>07</s5></fC03><fC03 i1="05" i2="X" l="ENG"><s0>IgA</s0><s5>07</s5></fC03><fC03 i1="05" i2="X" l="SPA"><s0>IgA</s0><s5>07</s5></fC03><fC03 i1="06" i2="X" l="FRE"><s0>Anticorps</s0><s5>08</s5></fC03><fC03 i1="06" i2="X" l="ENG"><s0>Antibody</s0><s5>08</s5></fC03><fC03 i1="06" i2="X" l="SPA"><s0>Anticuerpo</s0><s5>08</s5></fC03><fC03 i1="07" i2="X" l="FRE"><s0>Souche atténuée</s0><s5>09</s5></fC03><fC03 i1="07" i2="X" l="ENG"><s0>Attenuated strain</s0><s5>09</s5></fC03><fC03 i1="07" i2="X" l="SPA"><s0>Cepa atenuada</s0><s5>09</s5></fC03><fC03 i1="08" i2="X" l="FRE"><s0>Adjuvant immunologique</s0><s5>10</s5></fC03><fC03 i1="08" i2="X" l="ENG"><s0>Immunological adjuvant</s0><s5>10</s5></fC03><fC03 i1="08" i2="X" l="SPA"><s0>Coadyuvante inmunológico</s0><s5>10</s5></fC03><fC03 i1="09" i2="X" l="FRE"><s0>Muqueuse</s0><s5>11</s5></fC03><fC03 i1="09" i2="X" l="ENG"><s0>Mucosa</s0><s5>11</s5></fC03><fC03 i1="09" i2="X" l="SPA"><s0>Mucosa</s0><s5>11</s5></fC03><fC03 i1="10" i2="X" l="FRE"><s0>Grippe A</s0><s5>14</s5></fC03><fC03 i1="10" i2="X" l="ENG"><s0>Influenza A</s0><s5>14</s5></fC03><fC03 i1="10" i2="X" l="SPA"><s0>Gripe A</s0><s5>14</s5></fC03><fC03 i1="11" i2="X" l="FRE"><s0>Grippe aviaire</s0><s2>NM</s2><s5>15</s5></fC03><fC03 i1="11" i2="X" l="ENG"><s0>Avian influenza</s0><s2>NM</s2><s5>15</s5></fC03><fC03 i1="11" i2="X" l="SPA"><s0>Gripe aviar</s0><s2>NM</s2><s5>15</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>Infection</s0><s5>13</s5></fC07><fC07 i1="04" i2="X" l="ENG"><s0>Infection</s0><s5>13</s5></fC07><fC07 i1="04" i2="X" l="SPA"><s0>Infección</s0><s5>13</s5></fC07><fC07 i1="05" i2="X" l="FRE"><s0>Virose</s0></fC07><fC07 i1="05" i2="X" l="ENG"><s0>Viral disease</s0></fC07><fC07 i1="05" i2="X" l="SPA"><s0>Virosis</s0></fC07><fN21><s1>300</s1></fN21><fN44 i1="01"><s1>OTO</s1></fN44><fN82><s1>OTO</s1></fN82></pA></standard></inist><affiliations><list><country><li>États-Unis</li></country><region><li>Alabama</li><li>Pennsylvanie</li></region></list><tree><country name="États-Unis"><region name="Alabama"><name sortKey="Overton, Edgar Turner" sort="Overton, Edgar Turner" uniqKey="Overton E" first="Edgar Turner" last="Overton">Edgar Turner Overton</name></region><name sortKey="Carter, William A" sort="Carter, William A" uniqKey="Carter W" first="William A." last="Carter">William A. Carter</name><name sortKey="Cunningham, Pamela" sort="Cunningham, Pamela" uniqKey="Cunningham P" first="Pamela" last="Cunningham">Pamela Cunningham</name><name sortKey="Goepfert, Paul A" sort="Goepfert, Paul A" uniqKey="Goepfert P" first="Paul A." last="Goepfert">Paul A. Goepfert</name><name sortKey="Horvath, Joseph" sort="Horvath, Joseph" uniqKey="Horvath J" first="Joseph" last="Horvath">Joseph Horvath</name><name sortKey="Strayer, David R" sort="Strayer, David R" uniqKey="Strayer D" first="David R." last="Strayer">David R. Strayer</name><name sortKey="Young, Diane" sort="Young, Diane" uniqKey="Young D" first="Diane" last="Young">Diane Young</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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|texte= Intranasal seasonal influenza vaccine and a TLR-3 agonist, rintatolimod, induced cross-reactive IgA antibody formation against avian H5N1 and H7N9 influenza HA in humans
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