Generalized ROC methods for immunogenicity data analysis of vaccine phase I studies in a seropositive population

References

• Cioppa GD, Jonsdottie I, Lewis D. Challenges in early clinical development of adjuvanted vaccines. Vaccine. 2015;33:B47–51. doi:10.1016/j.vaccine.2015.02.031. PMID:26022568.
   PubMed Web of Science ®Google Scholar
• Plotkin SA. Correlates of protection induced by vaccination. Clin Vaccine Immunol. 2010;17:1055–65.
   PubMed Web of Science ®Google Scholar
• Robbins HA, Kemp TJ, Porras C, Rodriguez AC, Schiffman M, Wacholder S, et al. Comparison of antibody responses to human papillomavirus vaccination as measured by three assays. Front Oncol. 2013;3:328.
   Google Scholar
• Goldblatt D, Ashton L, Zhang Y, Antonello J, Marchese RD. Comparison of a new multiplex binding assay versus the enzyme-linked immunosorbent assay for measurement of serotype-specific pneumococcal capsular polysaccharide IgG. Clin Vaccine Immunol. 2011;18:1744–51. doi:10.1128/CVI.05158-11. PMID:21813660.
   PubMed Web of Science ®Google Scholar
• Opalka D, Matys K, Bojczuk P, Green T, Gesser R, Saah A, Haupt R, Dutko F, Esser MT. Multiplexed serologic assay for nine anogenital human papillomavirus types. Clin Vaccine Immunol. 2010;17:818–27. doi:10.1128/CVI.00348-09. PMID:20237197.
   PubMed Web of Science ®Google Scholar
• Dias D, Doren JV, Schlottmann S, Kelly S, Puchalski D, Ruiz W, Boerckel P, Kessler J, Antonello JM, Green T, et al. Optimization and validation of a multiplexed luminex assay to quantify antibodies to neutralizing epitopes on human papillomaviruses 6, 11, 16, and 18. Clin Diagn Lab Immunol. 2005;12:959–69. PMID:16085914.
   PubMedGoogle Scholar
• Ruiz W, McClements WL, Jansen KU, Esser MT. Kinetics and isotype profile of antibody responses in rhesus macaques induced following vaccination with HPV 6, 11, 16 and 18 L1-virus-like particles formulated with or without Merck aluminum adjuvant. J Immune Based Ther Vaccines. 2005;3:2. doi:10.1186/1476-8518-3-2. PMID:15842730.
   PubMedGoogle Scholar
• Romero-Steiner S, Frasch CE, Carlone G, Fleck RA. Use of opsonophagocytosis for serological evaluation of pneumococcal vaccines. Clin Vaccine Immunol. 2006;13:165–9. doi:10.1128/CVI.13.2.165-169.2006. PMID:16467321.
   PubMed Web of Science ®Google Scholar
• Plikaytisa BD, Carloneb GM. Statistical considerations for vaccine immunogenicity trials Part 1: introduction and bioassay design and analysis. Vaccine. 2005;23:1596–605. doi:10.1016/j.vaccine.2004.06.046. PMID:15694512.
   PubMed Web of Science ®Google Scholar
• Madore DV, Meade BD, Rubin F, Deal C, Lynn F; Meeting Contributors. Utilization of serologic assays to support efficacy of vaccines in nonclinical and clinical trials: meeting at the crossroads. Vaccine. 2010;28:4539–47. doi:10.1016/j.vaccine.2010.04.094. PMID:20470795.
   PubMed Web of Science ®Google Scholar
• Findlay J, Smith W, Lee J, Nordblom G, Das I, DeSilva B, Khan MN, Bowsher RR. Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective. J Pharm Biomed Anal. 2000;21:1249–73. doi:10.1016/S0731-7085(99)00244-7. PMID:10708409.
   PubMed Web of Science ®Google Scholar
• Beyer W, Palache A, Lüchters G, Nauta J, Osterhaus A. Seroprotection rate, mean fold increase, seroconversion rate: which parameter adequately expresses seroresponse to influenza vaccination? Virus Res. 2004;103:125–32. doi:10.1016/j.virusres.2004.02.024. PMID:15163500.
   PubMed Web of Science ®Google Scholar
• Nauta J. Statistics in Clinical Vaccine Trials. Berlin Heidelberg: Springer-Verlag; 2011.
   Google Scholar
• Katz J, Hancock K, Xu X. Serologic assays for influenza surveillance, diagnosis and vaccine evaluation. Expert Rev Anti Infect Ther. 2011;9:669–83. doi:10.1586/eri.11.51. PMID:21692672.
   PubMed Web of Science ®Google Scholar
• Wood J, Gaines-Das R, Taylor J, Chakraverty P. Comparison of influenza serological techniques by international collaborative study. Vaccine. 1994;12:167–74. doi:10.1016/0264-410X(94)90056-6. PMID:8147099.
   PubMed Web of Science ®Google Scholar
• Jacobson RM, Grill DE, Oberg AL, Tosh PK, Ovsyannikoval IG, Poland GA. Profiles of influenza A/H1N1 vaccine response using hemagglutination-inhibition titers. Hum Vaccines Immunother 2015;11:961–9. doi:10.1080/21645515.2015.1011990.
   PubMed Web of Science ®Google Scholar
• Collins P, Melero J. Progress in understanding and controlling respiratory syncytial virus: still crazy after all these years. Virus Res. 2011;162:80–99. doi:10.1016/j.virusres.2011.09.020. PMID:21963675.
   PubMed Web of Science ®Google Scholar
• Youden W. Index for rating diagnostic tests. Cancer 1950;3:32–5. doi:10.1002/1097-0142(1950)3:1<32::AID-CNCR2820030106>3.0.CO;2-3. PMID:15405679.
   PubMed Web of Science ®Google Scholar
• Fluss R, Faraggi D, Reiser B. Estimation of the Youden Index and its associated cutoff point. Biometrical J. 2005;4:458–72 doi:10.1002/bimj.200410135.
   Google Scholar
• Falloon J, Ji F, Curtis C, Bart S, Sheldon E, Krieger D, Dubovsky F, Lambert S, Takas T, Villafana T, et al. A phase 1a, first-in-human, randomized study of a respiratory syncytial virus F protein vaccine with and without a toll-like receptor-4 agonist and stable emulsion adjuvant. Vaccine 2016;34:2847–51. doi:10.1016/j.vaccine.2016.04.002. PMID:27102821.
   PubMed Web of Science ®Google Scholar
• Patton K, Aslam S, Lin J, Yu L, Lambert S, Dawes G, Esser MT, Woo J, Janetzki S, Cherukuri A. Enzyme-linked immunospot assay for detection of human respiratory syncytial virus F protein-specific gamma interferon-producing T cells. Clin Vaccine Immunol. 2014;21:628–35. doi:10.1128/CVI.00736-13. PMID:24574540.
   PubMed Web of Science ®Google Scholar
• Maifeld SV, Ro B, Mok H, Chu M, Yu L, Yamagata R, Leonardson T, Chio V, Parhy B, Park S, et al. Development of electrochemiluminescent serology assays to measure the humoral response to antigens of respiratory syncytial virus. PLoS One. 2016;11:e0153019 doi:10.1371/journal.pone.0153019. PMID:27070145.
   PubMed Web of Science ®Google Scholar
• Hanley JA, McNeil BJ. The meaning and use of the area under a receiver operating characteristic (ROC) curve. Radiology. 1982;143:29–36. doi:10.1148/radiology.143.1.7063747. PMID:7063747.
   PubMed Web of Science ®Google Scholar
• Krzanowski WJ, Hand DJ. ROC Curves for Continuous Data. Boca Raton, FL: CRC Press; 2009.
   Google Scholar
• Genz AC, Malik AA. Remarks on algorithm 006: An adaptive algorithm for numeric integration over an N-dimensional rectangular region. J Comput Applied Math. 1980;6:295–302. doi:10.1016/0771-050X(80)90039-X.
   Google Scholar
• Bernstsen J, Espelid TO, Genz A. An adaptive algorithm for the approximate calculation of multiple integrals. ACM Transactions Math Software (TOMS). 1991;17:437–51. doi:10.1145/210232.210233.
   Web of Science ®Google Scholar
• Hyndman RJ, Fan Y. Sample quantiles in statistical packages. Am Stat 1996;50:361–5.
   Web of Science ®Google Scholar
• The R Project for Statistical Computing. Available at: https://cran.r-project.org.
   Google Scholar
• Efron B, Tibshirani R. An Introduction to the Bootstrap. New York: Chapman & Hall; 1993.
   Google Scholar
• Qin G, Hotilovac L. Comparision of non-parametric confidence intervals for the area under the ROC curve of a continuous-scale diagnostic test. Stat Methods Med Res. 2008;17:207–21. doi:10.1177/0962280207087173. PMID:18426855.
   PubMed Web of Science ®Google Scholar
• Good P. Permutation, Parametric and Bootstrap Tests of Hypotheses. New York: Springer; 2005.
   Google Scholar
• Clopper CJ, Pearson ES. The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika. 1934;26:404–13. doi:10.1093/biomet/26.4.404.
   Web of Science ®Google Scholar
• Falloon J, Talbot K, Curtis C, Ervin J, Krieger D, Dubovsky F, Takas T, Yu J, Yu L, Lambert SL, et al. Dose selection for an adjuvanted respiratory syncytial virus F protein vaccine for older adults based on humoral and cellular immune responses. Clin Vaccine Immunol. 2017;24:e00157–17.
   PubMed Web of Science ®Google Scholar