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@ARTICLE{Tsang:157247,
      author       = {S. H. Tsang and P. Basu and N. Bender$^*$ and R. Herrero
                      and T. J. Kemp and A. R. Kreimer and M. Müller$^*$ and G.
                      Panicker and M. Pawlita$^*$ and L. A. Pinto and J. N.
                      Sampson and R. Sankaranarayanan and J. Schussler and P.
                      Sehr$^*$ and M. S. Sierra and E. R. Unger and T.
                      Waterboer$^*$ and A. Hildesheim},
      collaboration = {C. R. V. Trial},
      title        = {{E}valuation of serological assays to monitor antibody
                      responses to single-dose {HPV} vaccines.},
      journal      = {Vaccine},
      volume       = {38},
      number       = {38},
      issn         = {0264-410X},
      address      = {Amsterdam},
      publisher    = {Elsevier},
      reportid     = {DKFZ-2020-01504},
      pages        = {5997-6006},
      year         = {2020},
      note         = {2020 Aug 27;38(38):5997-6006},
      abstract     = {Whether existing serological assays are sufficiently robust
                      to measure the lower antibody levels expected following
                      single-dose HPV vaccination is unknown.We evaluated seven
                      assays measuring HPV-16/18 immunological responses overall
                      and by number of doses in 530 serum samples from
                      participants receiving varying doses of Cervarix or Gardasil
                      up to 36-months post-vaccination. Serum was evaluated by
                      simplex (HPV-16 ELISA, HPV-18 ELISA), multiplex (LIA-4,
                      VLP-MIA, M9ELISA, GST-L1), and high-throughput
                      pseudovirion-based neutralization assays (HT-PBNA), and
                      results were compared to the gold standard HPV-16/18
                      secreted alkaline phosphatase neutralization assay
                      (SEAP-NA). Reproducibility was assessed by the coefficient
                      of variation (CV) and intraclass correlation coefficient
                      (ICC). Percent agreement, Pearson correlation, and
                      weighted-kappa were used to assess validity. Determinants of
                      seronegativity were evaluated by chi-squared test.HPV-16:
                      Seropositivity range was $97.1-99.5\%$ for single dose and
                      $98.8-99.8\%$ overall. CV range was $4.0-18.0\%$ for single
                      dose and $2.9-19.5\%$ overall. ICC range was 0.77-0.99 for
                      single dose and 0.74-0.99 overall. Correlation with SEAP-NA
                      range was 0.43-0.85 for single dose and 0.51-0.90 overall.
                      Weighted-kappa range was 0.34-0.82 for single dose and
                      0.45-0.84 overall. HPV-18: Seropositivity range was
                      $63.9-94.7\%$ for single dose and $86.2-97.9\%$ overall. CV
                      range was $8.1-18.2\%$ for single dose and $4.6-18.6\%$
                      overall. ICC range was 0.75-0.99 for single dose and
                      0.83-0.99 overall. Correlation with SEAP-NA range was
                      0.31-0.99 for single dose and 0.27-0.96 overall.
                      Weighted-kappa range was 0.35-0.83 for single dose and
                      0.45-0.84 overall. HPV-16 seronegativity was $<5\%$ for all
                      assays. HPV-18 seronegativity range was $5.5-17.3\%.$ For
                      LIA-4 and GST-L1 where the proportion of seronegativity was
                      $>10\%,$ the strongest correlates of seronegativity were
                      receiving a single vaccine dose and receiving Gardasil.These
                      results support the utility of existing serological assays
                      to monitor antibody responses following single-dose HPV
                      vaccination.},
      cin          = {F022 / F020 / W040},
      ddc          = {610},
      cid          = {I:(DE-He78)F022-20160331 / I:(DE-He78)F020-20160331 /
                      I:(DE-He78)W040-20160331},
      pnm          = {316 - Infections and cancer (POF3-316)},
      pid          = {G:(DE-HGF)POF3-316},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:32713678},
      doi          = {10.1016/j.vaccine.2020.07.017},
      url          = {https://inrepo02.dkfz.de/record/157247},
}