title: Correlation between levels of human papillomavirus (HPV)-16 and 18 antibodies in serum and cervicovaginal secretions in girls and women vaccinated with the HPV-16/18 AS04-adjuvanted vaccine.
abstract: This pooled analysis of data from four Phase III clinical trials was undertaken to assess the correlation between levels of anti-human papillomavirus (HPV)-16/18 antibodies in serum and cervicovaginal secretions (CVS) in girls and women vaccinated with the HPV-16/18 AS04-adjuvanted vaccine. Serum and CVS samples were collected from a subset of women aged 10-65 years (N=350) at pre-specified time-points from 7 to 36 months post-vaccination. Anti-HPV-16/18 antibody levels in serum and CVS were measured by enzyme-linked immunosorbent assay. Pearson correlation coefficients between serum and CVS antibody levels, standardized for total immunoglobulin G, were calculated at each time-point in women with detectable antibodies in both serum and CVS. All subjects had seroconverted at Month 7 and remained seropositive through Month 36 for both antigens. Geometric mean titers of anti-HPV-16/18 antibodies in serum were substantially higher at all time-points than those in a control group of women who had cleared a natural HPV infection in another trial. In women with detectable antibodies in both serum and CVS, good correlation was seen between HPV-16/18 antibody levels at all time-points (Pearson correlation coefficient: 0.84-0.92 for HPV-16 and 0.90-0.91 for HPV-18). The strong correlation between levels of HPV-16/18 antibodies in serum and CVS up to 36 months post-vaccination in girls and women vaccinated with the HPV-16/18 AS04-adjuvanted vaccine supports transudation of serum antibodies as the mechanism by which antibodies are introduced into CVS. These CVS antibodies may play a role in the protective efficacy of this vaccine.
authors.affiliation: Central Laboratory and Vaccination Centre, Stiftung Juliusspital, Wuerzburg, Germany. t.schwarz@juliusspital.de
authors.forename: Tino F
authors.initials: TF
authors.lastname: Schwarz
authors.forename: Mariëlle
authors.initials: M
authors.lastname: Kocken
authors.forename: Tiina
authors.initials: T
authors.lastname: Petäjä
authors.forename: Mark H
authors.initials: MH
authors.lastname: Einstein
authors.forename: Marek
authors.initials: M
authors.lastname: Spaczynski
authors.forename: Jacqueline A
authors.initials: JA
authors.lastname: Louwers
authors.forename: Court
authors.initials: C
authors.lastname: Pedersen
authors.forename: Myron
authors.initials: M
authors.lastname: Levin
authors.forename: Toufik
authors.initials: T
authors.lastname: Zahaf
authors.forename: Sylviane
authors.initials: S
authors.lastname: Poncelet
authors.forename: Karin
authors.initials: K
authors.lastname: Hardt
authors.forename: Dominique
authors.initials: D
authors.lastname: Descamps
authors.forename: Gary
authors.initials: G
authors.lastname: Dubin
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D000293:Adolescent; D000328:Adult; D000368:Aged; D000914:Antibodies, Viral / Q000032:analysis* / Q000097:blood*; D012634:Bodily Secretions / Q000276:immunology; D002584:Cervix Uteri / Q000276:immunology*; D002648:Child; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D052162:Human papillomavirus 16 / Q000276:immunology; D052161:Human papillomavirus 18 / Q000276:immunology; D006801:Humans; D007074:Immunoglobulin G / Q000032:analysis / Q000097:blood; D008875:Middle Aged; D053918:Papillomavirus Vaccines / Q000008:administration & dosage / Q000276:immunology*; D044967:Serum / Q000276:immunology*; D014621:Vagina / Q000276:immunology*; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D007074:Immunoglobulin G; D053918:Papillomavirus Vaccines; C510352:human papillomavirus vaccine, L1 type 16, 18