Evaluation of potential immunogenicity differences between Pandemrix™ and Arepanrix™.
Identifieur interne : 000157 ( Main/Exploration ); précédent : 000156; suivant : 000158Evaluation of potential immunogenicity differences between Pandemrix™ and Arepanrix™.
Auteurs : Quentin Canelle [Belgique] ; Walthère Dewé [Belgique] ; Bruce L. Innis [Belgique] ; Robbert Van Der Most [Belgique]Source :
- Human vaccines & immunotherapeutics [ 2164-554X ] ; 2016.
Descripteurs français
- KwdFr :
- Affinité des anticorps, Anticorps antiviraux (sang), Enfant, Enfant d'âge préscolaire, Europe, Femelle, Glycoprotéine hémagglutinine du virus influenza (immunologie), Grippe humaine (), Humains, Immunoglobuline G (immunologie), Liaison aux protéines, Mâle, Protéines recombinantes (immunologie), Québec, Résonance plasmonique de surface, Vaccins antigrippaux (administration et posologie), Vaccins antigrippaux (immunologie).
- MESH :
- administration et posologie : Vaccins antigrippaux.
- immunologie : Glycoprotéine hémagglutinine du virus influenza, Immunoglobuline G, Protéines recombinantes, Vaccins antigrippaux.
- sang : Anticorps antiviraux.
- Affinité des anticorps, Enfant, Enfant d'âge préscolaire, Europe, Femelle, Grippe humaine, Humains, Liaison aux protéines, Mâle, Québec, Résonance plasmonique de surface.
English descriptors
- KwdEn :
- Antibodies, Viral (blood), Antibody Affinity, Child, Child, Preschool, Europe, Female, Hemagglutinin Glycoproteins, Influenza Virus (immunology), Humans, Immunoglobulin G (immunology), Influenza Vaccines (administration & dosage), Influenza Vaccines (immunology), Influenza, Human (prevention & control), Male, Protein Binding, Quebec, Recombinant Proteins (immunology), Surface Plasmon Resonance.
- MESH :
- chemical , administration & dosage : Influenza Vaccines.
- chemical , blood : Antibodies, Viral.
- chemical , immunology : Hemagglutinin Glycoproteins, Influenza Virus, Immunoglobulin G, Influenza Vaccines, Recombinant Proteins.
- prevention & control : Influenza, Human.
- Antibody Affinity, Child, Child, Preschool, Europe, Female, Humans, Male, Protein Binding, Quebec, Surface Plasmon Resonance.
Abstract
In retrospective observational studies, an increased relative risk of incident narcolepsy was observed in some European countries among recipients of the AS03-adjuvanted, A(H1N1)pdm09, inactivated, detergent-split virion vaccine Pandemrix™ manufactured in Dresden, Germany (D-Pan H1N1). A similar increased risk was not observed in a retrospective population-based study in individuals in Quebec province, Canada, who received Aprepanrix™, a Quebec-manufactured AS03-adjuvanted A(H1N1)pdm09 inactivated, detergent-split virion vaccine (Q-Pan H1N1). Antibody responses in D-Pan versus Q-Pan vaccinees (adults/children) measured as hemagglutination inhibition (HI) titers 21 d post-vaccination were found to be equivalent (NCT01161160). The current post-hoc analysis was conducted to determine whether antibody avidity differed following immunization with the 2 vaccines. Using surface plasmon resonance, we evaluated the capacity of serum specimens (drawn from the comparative immunogenicity trial) from a subset of subjects aged 3-9 y who received either D-Pan or Q-Pan (N = 28/group), to bind to recombinant A(H1N1)pdm09 hemagglutinin. IgG antibodies were purified from Day 21 sera. Binding was assessed by end association level; dissociation by retention of antigen-antibody complexes at the end of the dissociation phase, and kd. Inter-run variability for the control monoclonal antibody, association levels and dissociation levels was low (CVs 1.3%, 7.8% and 1.4%, respectively); non-specific binding was negligible. High avidity and slow dissociation was observed for both groups (kd ≤ 10(-4)/s; geometric mean [IQR] association and dissociation levels for D-Pan/Q-Pan: 15.4 RU [13.4-17.7]/12.4 RU [10.8-14.3] and 94.5% [92.5-96.5]/95.5% [93.5-97.6], respectively). Association, but not dissociation levels correlated with HI titers. No significant differences in avidity parameters were observed between D-Pan and Q-Pan sera.
DOI: 10.1080/21645515.2016.1168954
PubMed: 27105343
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
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<front><div type="abstract" xml:lang="en">In retrospective observational studies, an increased relative risk of incident narcolepsy was observed in some European countries among recipients of the AS03-adjuvanted, A(H1N1)pdm09, inactivated, detergent-split virion vaccine Pandemrix™ manufactured in Dresden, Germany (D-Pan H1N1). A similar increased risk was not observed in a retrospective population-based study in individuals in Quebec province, Canada, who received Aprepanrix™, a Quebec-manufactured AS03-adjuvanted A(H1N1)pdm09 inactivated, detergent-split virion vaccine (Q-Pan H1N1). Antibody responses in D-Pan versus Q-Pan vaccinees (adults/children) measured as hemagglutination inhibition (HI) titers 21 d post-vaccination were found to be equivalent (NCT01161160). The current post-hoc analysis was conducted to determine whether antibody avidity differed following immunization with the 2 vaccines. Using surface plasmon resonance, we evaluated the capacity of serum specimens (drawn from the comparative immunogenicity trial) from a subset of subjects aged 3-9 y who received either D-Pan or Q-Pan (N = 28/group), to bind to recombinant A(H1N1)pdm09 hemagglutinin. IgG antibodies were purified from Day 21 sera. Binding was assessed by end association level; dissociation by retention of antigen-antibody complexes at the end of the dissociation phase, and kd. Inter-run variability for the control monoclonal antibody, association levels and dissociation levels was low (CVs 1.3%, 7.8% and 1.4%, respectively); non-specific binding was negligible. High avidity and slow dissociation was observed for both groups (kd ≤ 10(-4)/s; geometric mean [IQR] association and dissociation levels for D-Pan/Q-Pan: 15.4 RU [13.4-17.7]/12.4 RU [10.8-14.3] and 94.5% [92.5-96.5]/95.5% [93.5-97.6], respectively). Association, but not dissociation levels correlated with HI titers. No significant differences in avidity parameters were observed between D-Pan and Q-Pan sera.</div>
</front>
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<Abstract><AbstractText>In retrospective observational studies, an increased relative risk of incident narcolepsy was observed in some European countries among recipients of the AS03-adjuvanted, A(H1N1)pdm09, inactivated, detergent-split virion vaccine Pandemrix™ manufactured in Dresden, Germany (D-Pan H1N1). A similar increased risk was not observed in a retrospective population-based study in individuals in Quebec province, Canada, who received Aprepanrix™, a Quebec-manufactured AS03-adjuvanted A(H1N1)pdm09 inactivated, detergent-split virion vaccine (Q-Pan H1N1). Antibody responses in D-Pan versus Q-Pan vaccinees (adults/children) measured as hemagglutination inhibition (HI) titers 21 d post-vaccination were found to be equivalent (NCT01161160). The current post-hoc analysis was conducted to determine whether antibody avidity differed following immunization with the 2 vaccines. Using surface plasmon resonance, we evaluated the capacity of serum specimens (drawn from the comparative immunogenicity trial) from a subset of subjects aged 3-9 y who received either D-Pan or Q-Pan (N = 28/group), to bind to recombinant A(H1N1)pdm09 hemagglutinin. IgG antibodies were purified from Day 21 sera. Binding was assessed by end association level; dissociation by retention of antigen-antibody complexes at the end of the dissociation phase, and kd. Inter-run variability for the control monoclonal antibody, association levels and dissociation levels was low (CVs 1.3%, 7.8% and 1.4%, respectively); non-specific binding was negligible. High avidity and slow dissociation was observed for both groups (kd ≤ 10(-4)/s; geometric mean [IQR] association and dissociation levels for D-Pan/Q-Pan: 15.4 RU [13.4-17.7]/12.4 RU [10.8-14.3] and 94.5% [92.5-96.5]/95.5% [93.5-97.6], respectively). Association, but not dissociation levels correlated with HI titers. No significant differences in avidity parameters were observed between D-Pan and Q-Pan sera.</AbstractText>
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<AffiliationInfo><Affiliation>a GSK Vaccines , Rixensart , Belgium.</Affiliation>
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<ForeName>Bruce L</ForeName>
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<Author ValidYN="Y"><LastName>van der Most</LastName>
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