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| 024 | 7 | _ | |a 10.1016/j.vaccine.2020.07.017 |2 doi |
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| 100 | 1 | _ | |a Tsang, Sabrina H |b 0 |
| 245 | _ | _ | |a Evaluation of serological assays to monitor antibody responses to single-dose HPV vaccines. |
| 260 | _ | _ | |a Amsterdam |c 2020 |b Elsevier |
| 336 | 7 | _ | |a article |2 DRIVER |
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| 336 | 7 | _ | |a Journal Article |b journal |m journal |0 PUB:(DE-HGF)16 |s 1635316954_1489 |2 PUB:(DE-HGF) |
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| 500 | _ | _ | |a 2020 Aug 27;38(38):5997-6006 |
| 520 | _ | _ | |a 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. |
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| 700 | 1 | _ | |a Herrero, Rolando |b 3 |
| 700 | 1 | _ | |a Kemp, Troy J |b 4 |
| 700 | 1 | _ | |a Kreimer, Aimée R |b 5 |
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| 700 | 1 | _ | |a Panicker, Gitika |b 7 |
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| 700 | 1 | _ | |a Sampson, Joshua N |b 10 |
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| 700 | 1 | _ | |a Hildesheim, Allan |b 17 |
| 700 | 1 | _ | |a Trial, Costa Rica Vaccine |b 18 |e Collaboration Author |
| 773 | _ | _ | |a 10.1016/j.vaccine.2020.07.017 |g p. S0264410X20309178 |0 PERI:(DE-600)1468474-3 |n 38 |p 5997-6006 |t Vaccine |v 38 |y 2020 |x 0264-410X |
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