Inactivated influenza vaccine stress can affect in vitro potency assay relationship to immunogenicity.
Identifieur interne : 000998 ( Main/Exploration ); précédent : 000997; suivant : 000999Inactivated influenza vaccine stress can affect in vitro potency assay relationship to immunogenicity.
Auteurs : Yingxia Wen [États-Unis] ; Giuseppe Palladino [États-Unis] ; Yuhong Xie [États-Unis] ; Annette Ferrari [États-Unis] ; Ethan C. Settembre [États-Unis]Source :
- Vaccine [ 1873-2518 ] ; 2018.
Descripteurs français
- KwdFr :
- Animaux, Anticorps antiviraux (sang), Concentration en ions d'hydrogène, Congélation, Efficacité du vaccin, Femelle, Glycoprotéine hémagglutinine du virus influenza (immunologie), Souris de lignée BALB C, Stockage de médicament (), Technologie pharmaceutique (), Température, Vaccins antigrippaux (administration et posologie), Vaccins antigrippaux (effets des radiations), Vaccins antigrippaux (immunologie), Vaccins antigrippaux (isolement et purification), Vaccins inactivés (administration et posologie), Vaccins inactivés (effets des radiations), Vaccins inactivés (immunologie), Vaccins inactivés (isolement et purification).
- MESH :
- administration et posologie : Vaccins antigrippaux, Vaccins inactivés.
- effets des radiations : Vaccins antigrippaux, Vaccins inactivés.
- immunologie : Glycoprotéine hémagglutinine du virus influenza, Vaccins antigrippaux, Vaccins inactivés.
- isolement et purification : Vaccins antigrippaux, Vaccins inactivés.
- sang : Anticorps antiviraux.
- Animaux, Concentration en ions d'hydrogène, Congélation, Efficacité du vaccin, Femelle, Souris de lignée BALB C, Stockage de médicament, Technologie pharmaceutique, Température.
English descriptors
- KwdEn :
- Animals, Antibodies, Viral (blood), Drug Storage (methods), Female, Freezing, Hemagglutinin Glycoproteins, Influenza Virus (immunology), Hydrogen-Ion Concentration, Influenza Vaccines (administration & dosage), Influenza Vaccines (immunology), Influenza Vaccines (isolation & purification), Influenza Vaccines (radiation effects), Mice, Inbred BALB C, Technology, Pharmaceutical (methods), Temperature, Vaccine Potency, Vaccines, Inactivated (administration & dosage), Vaccines, Inactivated (immunology), Vaccines, Inactivated (isolation & purification), Vaccines, Inactivated (radiation effects).
- MESH :
- chemical , administration & dosage : Influenza Vaccines, Vaccines, Inactivated.
- chemical , blood : Antibodies, Viral.
- chemical , immunology : Hemagglutinin Glycoproteins, Influenza Virus, Influenza Vaccines, Vaccines, Inactivated.
- chemical , isolation & purification : Influenza Vaccines, Vaccines, Inactivated.
- methods : Drug Storage, Technology, Pharmaceutical.
- chemical , radiation effects : Influenza Vaccines, Vaccines, Inactivated.
- Animals, Female, Freezing, Hydrogen-Ion Concentration, Mice, Inbred BALB C, Temperature, Vaccine Potency.
Abstract
Influenza vaccines are the most effective intervention to prevent the substantial public health burden of seasonal and pandemic influenza. The capability of hemagglutinin (HA), the main antigen in inactivated influenza vaccines (IIVs), to elicit functional neutralizing antibodies determines IIV effectiveness. When HA is subjected to environmental stress during manufacturing or while stored prior to administration, such as low pH and temperature excursions, the HA immunological activity can be affected. Single-radial immunodiffusion (SRID), the standard in vitro potency assay for IIVs, is believed to specifically detect immunologically active HA and has been applied to evaluate HA stability against stress. Here we report that transient low pH treatment and freeze/thaw cycles with HA in PBS abolish SRID-quantified in vitro potency for all HAs of multiple influenza strains. Raised temperature substantially decreases in vitro potency with more extensive HA structural changes. Chemical stress and mechanical stress moderately change SRID in vitro potency values in a strain-dependent manner. Trypsin digestion, which selectively degrades stressed HA, followed by RP-HPLC quantification as a candidate alternative in vitro potency assay yields results comparable to SRID. Mouse immunogenicity studies confirm that HA stressed by transient low pH treatment does not elicit functional antibodies in vivo, nor does it have a measureable SRID value. However, HA stressed by raised temperature elicits high titers of functional antibodies in vivo despite substantial loss of SRID in vitro potency. This discrepancy between SRID in vitro potency and vaccine immunogenicity suggests that SRID may not reliably indicate IIV potency under all conditions. Further efforts to develop alternate potency assays that can better predict in vivo immunogenicity should continue along with additional studies exploring HA conformation, SRID values and consequent immunogenicity.
DOI: 10.1016/j.vaccine.2018.04.021
PubMed: 29680201
Affiliations:
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Settembre</name><affiliation wicri:level="2"><nlm:affiliation>Seqirus, A CSL Company, 50 Hampshire Street, Cambridge, MA 02139, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Seqirus, A CSL Company, 50 Hampshire Street, Cambridge, MA 02139</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author></analytic><series><title level="j">Vaccine</title><idno type="eISSN">1873-2518</idno><imprint><date when="2018" type="published">2018</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Animals</term><term>Antibodies, Viral (blood)</term><term>Drug Storage (methods)</term><term>Female</term><term>Freezing</term><term>Hemagglutinin Glycoproteins, Influenza Virus (immunology)</term><term>Hydrogen-Ion Concentration</term><term>Influenza Vaccines (administration & dosage)</term><term>Influenza Vaccines (immunology)</term><term>Influenza Vaccines (isolation & purification)</term><term>Influenza Vaccines (radiation effects)</term><term>Mice, Inbred BALB C</term><term>Technology, Pharmaceutical (methods)</term><term>Temperature</term><term>Vaccine Potency</term><term>Vaccines, Inactivated (administration & dosage)</term><term>Vaccines, Inactivated (immunology)</term><term>Vaccines, Inactivated (isolation & purification)</term><term>Vaccines, Inactivated (radiation effects)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Animaux</term><term>Anticorps antiviraux (sang)</term><term>Concentration en ions d'hydrogène</term><term>Congélation</term><term>Efficacité du vaccin</term><term>Femelle</term><term>Glycoprotéine hémagglutinine du virus influenza (immunologie)</term><term>Souris de lignée BALB C</term><term>Stockage de médicament ()</term><term>Technologie pharmaceutique ()</term><term>Température</term><term>Vaccins antigrippaux (administration et posologie)</term><term>Vaccins antigrippaux (effets des radiations)</term><term>Vaccins antigrippaux (immunologie)</term><term>Vaccins antigrippaux (isolement et purification)</term><term>Vaccins inactivés (administration et posologie)</term><term>Vaccins inactivés (effets des radiations)</term><term>Vaccins inactivés (immunologie)</term><term>Vaccins inactivés (isolement et purification)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Influenza Vaccines</term><term>Vaccines, Inactivated</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>Hemagglutinin Glycoproteins, Influenza Virus</term><term>Influenza Vaccines</term><term>Vaccines, Inactivated</term></keywords><keywords scheme="MESH" type="chemical" qualifier="isolation & purification" xml:lang="en"><term>Influenza Vaccines</term><term>Vaccines, Inactivated</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Vaccins antigrippaux</term><term>Vaccins inactivés</term></keywords><keywords scheme="MESH" qualifier="effets des radiations" xml:lang="fr"><term>Vaccins antigrippaux</term><term>Vaccins inactivés</term></keywords><keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Glycoprotéine hémagglutinine du virus influenza</term><term>Vaccins antigrippaux</term><term>Vaccins inactivés</term></keywords><keywords scheme="MESH" qualifier="isolement et purification" xml:lang="fr"><term>Vaccins antigrippaux</term><term>Vaccins inactivés</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Drug Storage</term><term>Technology, Pharmaceutical</term></keywords><keywords scheme="MESH" type="chemical" qualifier="radiation effects" xml:lang="en"><term>Influenza Vaccines</term><term>Vaccines, Inactivated</term></keywords><keywords scheme="MESH" qualifier="sang" xml:lang="fr"><term>Anticorps antiviraux</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Animals</term><term>Female</term><term>Freezing</term><term>Hydrogen-Ion Concentration</term><term>Mice, Inbred BALB C</term><term>Temperature</term><term>Vaccine Potency</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Animaux</term><term>Concentration en ions d'hydrogène</term><term>Congélation</term><term>Efficacité du vaccin</term><term>Femelle</term><term>Souris de lignée BALB C</term><term>Stockage de médicament</term><term>Technologie pharmaceutique</term><term>Température</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Influenza vaccines are the most effective intervention to prevent the substantial public health burden of seasonal and pandemic influenza. The capability of hemagglutinin (HA), the main antigen in inactivated influenza vaccines (IIVs), to elicit functional neutralizing antibodies determines IIV effectiveness. When HA is subjected to environmental stress during manufacturing or while stored prior to administration, such as low pH and temperature excursions, the HA immunological activity can be affected. Single-radial immunodiffusion (SRID), the standard in vitro potency assay for IIVs, is believed to specifically detect immunologically active HA and has been applied to evaluate HA stability against stress. Here we report that transient low pH treatment and freeze/thaw cycles with HA in PBS abolish SRID-quantified in vitro potency for all HAs of multiple influenza strains. Raised temperature substantially decreases in vitro potency with more extensive HA structural changes. Chemical stress and mechanical stress moderately change SRID in vitro potency values in a strain-dependent manner. Trypsin digestion, which selectively degrades stressed HA, followed by RP-HPLC quantification as a candidate alternative in vitro potency assay yields results comparable to SRID. Mouse immunogenicity studies confirm that HA stressed by transient low pH treatment does not elicit functional antibodies in vivo, nor does it have a measureable SRID value. However, HA stressed by raised temperature elicits high titers of functional antibodies in vivo despite substantial loss of SRID in vitro potency. This discrepancy between SRID in vitro potency and vaccine immunogenicity suggests that SRID may not reliably indicate IIV potency under all conditions. Further efforts to develop alternate potency assays that can better predict in vivo immunogenicity should continue along with additional studies exploring HA conformation, SRID values and consequent immunogenicity.</div></front></TEI><affiliations><list><country><li>États-Unis</li></country><region><li>Massachusetts</li></region></list><tree><country name="États-Unis"><region name="Massachusetts"><name sortKey="Wen, Yingxia" sort="Wen, Yingxia" uniqKey="Wen Y" first="Yingxia" last="Wen">Yingxia Wen</name></region><name sortKey="Ferrari, Annette" sort="Ferrari, Annette" uniqKey="Ferrari A" first="Annette" last="Ferrari">Annette Ferrari</name><name sortKey="Palladino, Giuseppe" sort="Palladino, Giuseppe" uniqKey="Palladino G" first="Giuseppe" last="Palladino">Giuseppe Palladino</name><name sortKey="Settembre, Ethan C" sort="Settembre, Ethan C" uniqKey="Settembre E" first="Ethan C" last="Settembre">Ethan C. Settembre</name><name sortKey="Xie, Yuhong" sort="Xie, Yuhong" uniqKey="Xie Y" first="Yuhong" last="Xie">Yuhong Xie</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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