Evaluation of potential immunogenicity differences between Pandemrix™ and Arepanrix™.
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.
a GSK Vaccines , Rixensart , Belgium.
Quentin
Q
Canelle
a GSK Vaccines , Rixensart , Belgium.
Walthère
W
Dewé
a GSK Vaccines , Rixensart , Belgium.
Bruce L
BL
Innis
a GSK Vaccines , Rixensart , Belgium.
Robbert
R
van der Most
D000914:Antibodies, Viral / Q000097:blood*; D000915:Antibody Affinity; D002648:Child; D002675:Child, Preschool; D005060:Europe; D005260:Female; D019267:Hemagglutinin Glycoproteins, Influenza Virus / Q000276:immunology; D006801:Humans; D007074:Immunoglobulin G / Q000276:immunology; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D011485:Protein Binding; D011792:Quebec; D011994:Recombinant Proteins / Q000276:immunology; D020349:Surface Plasmon Resonance
D000914:Antibodies, Viral; D019267:Hemagglutinin Glycoproteins, Influenza Virus; D007074:Immunoglobulin G; D007252:Influenza Vaccines; D011994:Recombinant Proteins; C568072:arepanrix; C556153:pandemrix
AS03; Arepanrix; H1N1; Pandemrix; antibody; avidity; hemagglutinin; immunogenicity; narcolepsy; vaccine