Skip NavigationSkip to Content
Return Return to Search Results

Evaluation of serological assays to monitor antibody responses to single-dose HPV vaccines

  1. Author:
    Tsang, Sabrina H
    Basu, Partha
    Bender, Noemi
    Herrero, Rolando
    Kemp,Troy
    Kreimer, Aimée R
    Müller, Martin
    Panicker, Gitika
    Pawlita, Michael
    Pinto,Ligia
    Sampson, Joshua N
    Sankaranarayanan, Rengaswamy
    Schussler, John
    Sehr, Peter
    Sierra, Monica S
    Unger, Elizabeth R
    Waterboer, Tim
    Hildesheim, Allan

  2. Author Address

    Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA., Screening Group, International Agency for Research on Cancer, Lyon, France., Infection, Inflammation & Cancer Program, German Cancer Research Center (DKFZ), Heidelberg, Germany., Agencia Costarricense de Investigaciones Biom 233;dicas (ACIB), formerly Proyecto Epidemiol 243;gico Guanacaste, Fundaci 243;n INCIENSA, San Jos 233;, Costa Rica., HPV Immunology Laboratory, Leidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research, Frederick, MD, USA., Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention, Atlanta, GA, USA., Research Triangle Institute International, New Delhi, India., Information Management Services, Silver Spring, MD, USA., Infection, Inflammation & Cancer Program, German Cancer Research Center (DKFZ), Heidelberg, Germany; Chemical Biology Core Facility, European Molecular Biology Laboratory (EMBL), Heidelberg, Germany., Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA. Electronic address: Hildesha@mail.nih.gov.,
    1. Year: 2020
    2. Date: AUG 27
    3. Epub Date: 2020 07 23
  2. Journal: Vaccine
    1. 38
    2. 38
    3. Pages: pii: S0264-410X(20)30917-8
  4. Type of Article: Article
  5. ISSN: 0264-410X
  1. Abstract:

    Introduction: Whether existing serological assays are sufficiently robust to measure the lower antibody levels expected following single-dose HPV vaccination is unknown. Methods: 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 weightedkappa were used to assess validity. Determinants of seronegativity were evaluated by chi-squared test. Results: 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. Conclusions:: These results support the utility of existing serological assays to monitor antibody responses following single-dose HPV vaccination. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

    See More

  1. Keywords:

External Sources

  1. View Full Text
  2. DOI: 10.1016/j.vaccine.2020.07.017
  3. PMID: 32713678
  4. View record in Web of Science®
  5. WOS: 000564257700005
  6. PII : S0264-410X(20)30917-8

Library Notes

  1. Fiscal Year: FY2019-2020
NCI at Frederick

You are leaving a government website.

This external link provides additional information that is consistent with the intended purpose of this site. The government cannot attest to the accuracy of a non-federal site.

Linking to a non-federal site does not constitute an endorsement by this institution or any of its employees of the sponsors or the information and products presented on the site. You will be subject to the destination site's privacy policy when you follow the link.

ContinueCancel