PandemieGrippaleV1, Main, Merge, bibRecord, 000E19

Phase II Trial in Adults of Concurrent or Sequential 2009 Pandemic H1N1 and 2009-2010 Seasonal Trivalent Influenza Vaccinations

Identifieur interne : 000E19 ( Main/Merge ); précédent : 000E18; suivant : 000E20

Phase II Trial in Adults of Concurrent or Sequential 2009 Pandemic H1N1 and 2009-2010 Seasonal Trivalent Influenza Vaccinations

Auteurs : Sharon E. Frey ; David I. Bernstein ; Rebecca C. Brady ; Wendy A. Keitel ; Hana El Sahly ; Nadine Georges Rouphael ; Mark J. Mulligan ; Robert L. Atmar ; Srilatha Edupuganti ; Shital M. Patel ; Michelle Dickey ; Irene Graham ; Edwin L. Anderson ; Diana L. Noah ; Heather Hill ; Mark Wolff ; Robert B. Belshe

Source :

Vaccine [ 0264-410X ] ; 2014.

RBID : PMC:4293632

Descripteurs français

KwdFr :
- Adolescent, Adulte, Adulte d'âge moyen, Anticorps antiviraux (sang), Calendrier vaccinal, Femelle, Grippe humaine (), Humains, Injections musculaires, Jeune adulte, Mâle, Placebo (administration et posologie), Sujet âgé, Sujet âgé de 80 ans ou plus, Tests d'inhibition de l'hémagglutination, Vaccination (), Vaccination (effets indésirables), Vaccins antigrippaux (administration et posologie), Vaccins antigrippaux (effets indésirables), Vaccins antigrippaux (immunologie).
MESH :
- administration et posologie : Placebo, Vaccins antigrippaux.
- effets indésirables : Vaccination, Vaccins antigrippaux.
- immunologie : Vaccins antigrippaux.
- sang : Anticorps antiviraux.
- Adolescent, Adulte, Adulte d'âge moyen, Calendrier vaccinal, Femelle, Grippe humaine, Humains, Injections musculaires, Jeune adulte, Mâle, Sujet âgé, Sujet âgé de 80 ans ou plus, Tests d'inhibition de l'hémagglutination, Vaccination.

English descriptors

KwdEn :
- Adolescent, Adult, Aged, Aged, 80 and over, Antibodies, Viral (blood), Female, Hemagglutination Inhibition Tests, Humans, Immunization Schedule, Influenza Vaccines (administration & dosage), Influenza Vaccines (adverse effects), Influenza Vaccines (immunology), Influenza, Human (prevention & control), Injections, Intramuscular, Male, Middle Aged, Placebos (administration & dosage), Vaccination (adverse effects), Vaccination (methods), Young Adult.
MESH :
- chemical , administration & dosage : Influenza Vaccines, Placebos.
- chemical , adverse effects : Influenza Vaccines.
- chemical , blood : Antibodies, Viral.
- chemical , immunology : Influenza Vaccines.
- adverse effects : Vaccination.
- methods : Vaccination.
- prevention & control : Influenza, Human.
- Adolescent, Adult, Aged, Aged, 80 and over, Female, Hemagglutination Inhibition Tests, Humans, Immunization Schedule, Injections, Intramuscular, Male, Middle Aged, Young Adult.

Abstract

Background

During the 2009 influenza pandemic both seasonal and 2009 pandemic vaccines were recommended. We conducted a randomized trial of monovalent 2009-H1N1 vaccine and seasonal trivalent inactivated influenza vaccine (IIV3) given sequentially or concurrently to adults.

Methods

Adults randomized to 4 study groups and stratified by age (18-64 and ≥65 years) received 1 dose of seasonal IIV3 or placebo and 2 doses of 2009-H1N1 vaccine or placebo in one of 4 combinations, i.e., H1N1+Placebo/H1N1+Placebo/IIV3 (HP/HP/V3), H1N1+ IIV3/H1N1+Placebo/Placebo (HV3/HP/P), H1N1+Placebo/H1N1+ IIV3/Placebo (HP/HV3/P), and IIV3+Placebo/H1N1+Placebo/H1N1 (V3P/HP/H). Intramuscular injections were given three times at 21 day intervals. Sera for antibody assays were obtained prior to and 21 days after each vaccination. Reactogenicity and adverse events were monitored.

Results

Eight hundred-five (805) adults were enrolled. All combinations of vaccines were safe and well tolerated. In general, one dose of 2009-H1N1 and one dose of IIV3, regardless of sequence or concurrency of administration, were immunogenic in adults. There were no significant differences in geometric mean titers (GMT) or the proportions of subjects with ≥4-fold rise in antibody responses and titers ≥40 for any vaccine group or between age strata for 2009-H1N1 after the first or second dose, although the vaccine sequence affected the titers to the IIV3 antigens. Hemagglutination inhibition antibody (HAI) GMTs against 2009-H1N1 for the combined age strata 21 days after the first 2009-H1N1 dose were 190.4, 182.1, 232.9 and 157.5 for HP/HP/V3, HV3/HP/P, HP/HV3/P and V3P/HP/H, respectively. While IIV3 GMTs were adequate they were generally lower than the 2009-H1N1 GMTs. In a subset of subjects, there was good correlation between HAI and microneutralization (MN) titers (Spearman's correlation coefficient 0.92).

Conclusions

All vaccine combinations were generally well tolerated. Immune responses to one dose of 2009-H1N1 were adequate regardless of the sequence of vaccination in all age groups, but the sequence affected titers to IIV3 antigens.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4293632

DOI: 10.1016/j.vaccine.2014.10.083
PubMed: 25444805
PubMed Central: 4293632

Links to Exploration step

PMC:4293632

Le document en format XML

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<author><name sortKey="Bernstein, David I" sort="Bernstein, David I" uniqKey="Bernstein D" first="David I." last="Bernstein">David I. Bernstein</name>
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<author><name sortKey="Brady, Rebecca C" sort="Brady, Rebecca C" uniqKey="Brady R" first="Rebecca C." last="Brady">Rebecca C. Brady</name>
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<author><name sortKey="Rouphael, Nadine Georges" sort="Rouphael, Nadine Georges" uniqKey="Rouphael N" first="Nadine Georges" last="Rouphael">Nadine Georges Rouphael</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Phase II Trial in Adults of Concurrent or Sequential 2009 Pandemic H1N1 and 2009-2010 Seasonal Trivalent Influenza Vaccinations</title>
<author><name sortKey="Frey, Sharon E" sort="Frey, Sharon E" uniqKey="Frey S" first="Sharon E." last="Frey">Sharon E. Frey</name>
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<author><name sortKey="Rouphael, Nadine Georges" sort="Rouphael, Nadine Georges" uniqKey="Rouphael N" first="Nadine Georges" last="Rouphael">Nadine Georges Rouphael</name>
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<wicri:noCountry code="subfield">Emory University School of Medicine</wicri:noCountry>
</affiliation>
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</affiliation>
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<author><name sortKey="Edupuganti, Srilatha" sort="Edupuganti, Srilatha" uniqKey="Edupuganti S" first="Srilatha" last="Edupuganti">Srilatha Edupuganti</name>
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</affiliation>
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<author><name sortKey="Patel, Shital M" sort="Patel, Shital M" uniqKey="Patel S" first="Shital M." last="Patel">Shital M. Patel</name>
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</affiliation>
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<author><name sortKey="Dickey, Michelle" sort="Dickey, Michelle" uniqKey="Dickey M" first="Michelle" last="Dickey">Michelle Dickey</name>
<affiliation><nlm:aff id="A2">Cincinnati Children's Hospital Medical Center, University of Cincinnati</nlm:aff>
<wicri:noCountry code="subfield">University of Cincinnati</wicri:noCountry>
</affiliation>
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<author><name sortKey="Graham, Irene" sort="Graham, Irene" uniqKey="Graham I" first="Irene" last="Graham">Irene Graham</name>
<affiliation><nlm:aff id="A1">Saint Louis University School of Medicine</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Anderson, Edwin L" sort="Anderson, Edwin L" uniqKey="Anderson E" first="Edwin L." last="Anderson">Edwin L. Anderson</name>
<affiliation><nlm:aff id="A1">Saint Louis University School of Medicine</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Noah, Diana L" sort="Noah, Diana L" uniqKey="Noah D" first="Diana L." last="Noah">Diana L. Noah</name>
<affiliation><nlm:aff id="A5">Southern Research Institute</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Hill, Heather" sort="Hill, Heather" uniqKey="Hill H" first="Heather" last="Hill">Heather Hill</name>
<affiliation><nlm:aff id="A6">The EMMES Corporation</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Wolff, Mark" sort="Wolff, Mark" uniqKey="Wolff M" first="Mark" last="Wolff">Mark Wolff</name>
<affiliation><nlm:aff id="A6">The EMMES Corporation</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Belshe, Robert B" sort="Belshe, Robert B" uniqKey="Belshe R" first="Robert B." last="Belshe">Robert B. Belshe</name>
<affiliation><nlm:aff id="A1">Saint Louis University School of Medicine</nlm:aff>
</affiliation>
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<series><title level="j">Vaccine</title>
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<term>Adult</term>
<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Antibodies, Viral (blood)</term>
<term>Female</term>
<term>Hemagglutination Inhibition Tests</term>
<term>Humans</term>
<term>Immunization Schedule</term>
<term>Influenza Vaccines (administration & dosage)</term>
<term>Influenza Vaccines (adverse effects)</term>
<term>Influenza Vaccines (immunology)</term>
<term>Influenza, Human (prevention & control)</term>
<term>Injections, Intramuscular</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Placebos (administration & dosage)</term>
<term>Vaccination (adverse effects)</term>
<term>Vaccination (methods)</term>
<term>Young Adult</term>
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<keywords scheme="KwdFr" xml:lang="fr"><term>Adolescent</term>
<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Anticorps antiviraux (sang)</term>
<term>Calendrier vaccinal</term>
<term>Femelle</term>
<term>Grippe humaine ()</term>
<term>Humains</term>
<term>Injections musculaires</term>
<term>Jeune adulte</term>
<term>Mâle</term>
<term>Placebo (administration et posologie)</term>
<term>Sujet âgé</term>
<term>Sujet âgé de 80 ans ou plus</term>
<term>Tests d'inhibition de l'hémagglutination</term>
<term>Vaccination ()</term>
<term>Vaccination (effets indésirables)</term>
<term>Vaccins antigrippaux (administration et posologie)</term>
<term>Vaccins antigrippaux (effets indésirables)</term>
<term>Vaccins antigrippaux (immunologie)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Influenza Vaccines</term>
<term>Placebos</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Influenza Vaccines</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Antibodies, Viral</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="immunology" xml:lang="en"><term>Influenza Vaccines</term>
</keywords>
<keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Placebo</term>
<term>Vaccins antigrippaux</term>
</keywords>
<keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Vaccination</term>
</keywords>
<keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Vaccination</term>
<term>Vaccins antigrippaux</term>
</keywords>
<keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Vaccins antigrippaux</term>
</keywords>
<keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Vaccination</term>
</keywords>
<keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Influenza, Human</term>
</keywords>
<keywords scheme="MESH" qualifier="sang" xml:lang="fr"><term>Anticorps antiviraux</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adolescent</term>
<term>Adult</term>
<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Female</term>
<term>Hemagglutination Inhibition Tests</term>
<term>Humans</term>
<term>Immunization Schedule</term>
<term>Injections, Intramuscular</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Young Adult</term>
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<keywords scheme="MESH" xml:lang="fr"><term>Adolescent</term>
<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Calendrier vaccinal</term>
<term>Femelle</term>
<term>Grippe humaine</term>
<term>Humains</term>
<term>Injections musculaires</term>
<term>Jeune adulte</term>
<term>Mâle</term>
<term>Sujet âgé</term>
<term>Sujet âgé de 80 ans ou plus</term>
<term>Tests d'inhibition de l'hémagglutination</term>
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<front><div type="abstract" xml:lang="en"><sec id="S1"><title>Background</title>
<p id="P1">During the 2009 influenza pandemic both seasonal and 2009 pandemic vaccines were recommended. We conducted a randomized trial of monovalent 2009-H1N1 vaccine and seasonal trivalent inactivated influenza vaccine (IIV3) given sequentially or concurrently to adults.</p>
</sec>
<sec id="S2"><title>Methods</title>
<p id="P2">Adults randomized to 4 study groups and stratified by age (18-64 and ≥65 years) received 1 dose of seasonal IIV3 or placebo and 2 doses of 2009-H1N1 vaccine or placebo in one of 4 combinations, i.e., H1N1+Placebo/H1N1+Placebo/<bold>II<italic>V</italic>
3</bold>
 (HP/HP/<bold>V3</bold>
), H1N1+ <bold>IIV3</bold>
/H1N1+Placebo/Placebo (H<bold>V3</bold>
/HP/P), H1N1+Placebo/H1N1+ <bold>IIV3</bold>
/Placebo (HP/H<bold>V3</bold>
/P), and II<bold>V3</bold>
+Placebo/H1N1+Placebo/H1N1 (<bold>V3</bold>
P/HP/H). Intramuscular injections were given three times at 21 day intervals. Sera for antibody assays were obtained prior to and 21 days after each vaccination. Reactogenicity and adverse events were monitored.</p>
</sec>
<sec id="S3"><title>Results</title>
<p id="P3">Eight hundred-five (805) adults were enrolled. All combinations of vaccines were safe and well tolerated. In general, one dose of 2009-H1N1 and one dose of IIV3, regardless of sequence or concurrency of administration, were immunogenic in adults. There were no significant differences in geometric mean titers (GMT) or the proportions of subjects with ≥4-fold rise in antibody responses and titers ≥40 for any vaccine group or between age strata for 2009-H1N1 after the first or second dose, although the vaccine sequence affected the titers to the IIV3 antigens. Hemagglutination inhibition antibody (HAI) GMTs against 2009-H1N1 for the combined age strata 21 days after the first 2009-H1N1 dose were 190.4, 182.1, 232.9 and 157.5 for HP/HP/<bold>V3</bold>
, H<bold>V3</bold>
/HP/P, HP/H<bold>V3</bold>
/P and <bold>V3</bold>
P/HP/H, respectively. While IIV3 GMTs were adequate they were generally lower than the 2009-H1N1 GMTs. In a subset of subjects, there was good correlation between HAI and microneutralization (MN) titers (Spearman's correlation coefficient 0.92).</p>
</sec>
<sec id="S4"><title>Conclusions</title>
<p id="P4">All vaccine combinations were generally well tolerated. Immune responses to one dose of 2009-H1N1 were adequate regardless of the sequence of vaccination in all age groups, but the sequence affected titers to IIV3 antigens.</p>
</sec>
</div>
</front>
</TEI>
</record>

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

HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 000E19 | SxmlIndent | more

HfdSelect -h $EXPLOR_AREA/Data/Main/Merge/biblio.hfd -nk 000E19 | SxmlIndent | more

Pour mettre un lien sur cette page dans le réseau Wicri

{{Explor lien
   |wiki=    Sante
   |area=    PandemieGrippaleV1
   |flux=    Main
   |étape=   Merge
   |type=    RBID
   |clé=     PMC:4293632
   |texte=   Phase II Trial in Adults of Concurrent or Sequential 2009 Pandemic H1N1 and 2009-2010 Seasonal Trivalent Influenza Vaccinations
}}

Pour générer des pages wiki

HfdIndexSelect -h $EXPLOR_AREA/Data/Main/Merge/RBID.i   -Sk "pubmed:25444805" \
       | HfdSelect -Kh $EXPLOR_AREA/Data/Main/Merge/biblio.hfd   \
       | NlmPubMed2Wicri -a PandemieGrippaleV1

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

Phase II Trial in Adults of Concurrent or Sequential 2009 Pandemic H1N1 and 2009-2010 Seasonal Trivalent Influenza Vaccinations

Phase II Trial in Adults of Concurrent or Sequential 2009 Pandemic H1N1 and 2009-2010 Seasonal Trivalent Influenza Vaccinations

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Descripteurs français

English descriptors

Abstract

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

Links to Exploration step

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

Pour mettre un lien sur cette page dans le réseau Wicri

Pour générer des pages wiki

	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.