title: Magnitude and quality of antibody response to a combination hepatitis A and hepatitis B vaccine.
abstract: Interference between antibodies generated by a combination hepatitis A and B vaccine was investigated by evaluating the quantity and quality of anti-hepatitis A virus (HAV) and anti-hepatitis B surface antigen (HBs) antibodies generated by Twinrix (Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine). The magnitude of the immune response was determined by a retrospective analysis of eight clinical trials, completed during stepwise development of Twinrix. The functionality of anti-HAV was evaluated by comparison of routine ELISA results with neutralization assays and was further characterized by defining the epitope-specificity of binding. Functionality of the anti-HBs response was not tested because a validated assay was not developed at the time this study was conducted. Results of all analyses demonstrated that the combination vaccine induced high antibody titers against hepatitis A and B and a functional anti-HAV response, with no evidence of immune interference to either viral antigen.
authors.affiliation: GlaxoSmithKline Pharmaceuticals, Collegeville, PA, USA. abrahab3@labs.wyeth.com
authors.forename: Betsy
authors.initials: B
authors.lastname: Abraham
authors.forename: Yaela
authors.initials: Y
authors.lastname: Baine
authors.forename: Norbert
authors.initials: N
authors.lastname: De-Clercq
authors.forename: Etienne
authors.initials: E
authors.lastname: Tordeur
authors.forename: Pascal P
authors.initials: PP
authors.lastname: Gerard
authors.forename: Patrick L
authors.initials: PL
authors.lastname: Manouvriez
authors.forename: Dennis L
authors.initials: DL
authors.lastname: Parenti
mesh_terms: D002986:Clinical Trials as Topic; D006506:Hepatitis A / Q000276:immunology / Q000517:prevention & control / Q000821:virology; D035922:Hepatitis A Antibodies; D022362:Hepatitis A Vaccines / Q000276:immunology*; D030041:Hepatitis A virus / Q000276:immunology*; D006508:Hepatitis Antibodies / Q000097:blood*; D006509:Hepatitis B / Q000276:immunology / Q000517:prevention & control / Q000821:virology; D006510:Hepatitis B Antibodies / Q000097:blood*; D017325:Hepatitis B Vaccines / Q000276:immunology*; D006515:Hepatitis B virus / Q000276:immunology*; D006801:Humans; D012189:Retrospective Studies; D017778:Vaccines, Combined
chemical_list: D035922:Hepatitis A Antibodies; D022362:Hepatitis A Vaccines; D006508:Hepatitis Antibodies; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; D017778:Vaccines, Combined; C433226:twinrix