Journal Article

DKFZ-2020-01504

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png Evaluation of serological assays to monitor antibody responses to single-dose HPV vaccines.

Tsang, S. H. ; Basu, P. ; Bender, N.DKFZ* ; Herrero, R. ; Kemp, T. J. ; Kreimer, A. R. ; Müller, M.DKFZ* ; Panicker, G. ; Pawlita, M.DKFZ* ; Pinto, L. A. ; Sampson, J. N. ; Sankaranarayanan, R. ; Schussler, J. ; Sehr, P.DKFZ* ; Sierra, M. S. ; Unger, E. R. ; Waterboer, T.DKFZ* ; Hildesheim, A. ; Trial, C. R. V. (Collaboration Author)

2020
Elsevier Amsterdam

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Please use a persistent id in citations: doi:10.1016/j.vaccine.2020.07.017

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.

Note: 2020 Aug 27;38(38):5997-6006

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Contributing Institute(s):

1. Infektionen und Krebs-Epidemiologie (F022)
2. Infektionen und Krebs-Epidemiologie (F020)
3. W040 SMS-Facillity (EMBL) (W040)

Research Program(s):

1. 316 - Infections and cancer (POF3-316) (POF3-316)

Appears in the scientific report 2020

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Database coverage:
; BIOSIS Previews ; Biological Abstracts ; Clarivate Analytics Master Journal List ; Current Contents - Life Sciences ; Ebsco Academic Search ; Essential Science Indicators ; IF < 5 ; JCR ; NCBI Molecular Biology Database ; Nationallizenz ; SCOPUS ; Science Citation Index ; Science Citation Index Expanded ; Web of Science Core Collection

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