ANTIBODY RESPONSES IN ORAL FLUID AND SERUM …



ANTIBODY RESPONSES IN ORAL FLUID AND SERUM FOLLOWING HPV VACCINATION

JJ Carter, Fred Hutchinson Cancer Research Center, Seattle, USA

A Rowhani - Rahbar, University of Washington, Seattle , USA

SE Hawes, University of Washington, Seattle, USA

JP Hughes, University of Washington, Seattle, USA

LA Koutsky, University of Washington, Seattle, USA

DA Galloway, Fred Hutchinson Cancer Research Center, Seattle, USA

BACKGROUND: Oral fluid sampling is simple, noninvasive, and painless, however, immunoglobulin G levels are lower than in serum. We sought to assess the potential utility of using oral mucosal transudate (OMT), collected by an OraSure® device, for detection of human papillomavirus type 16 (HPV-16) specific antibodies among women who had received a prophylactic HPV-16 L1 virus-like particle vaccine. METHODS: Vaccine recipients (139) and placebo controls (137) who had participated in a phase IIb randomized controlled vaccine trial (1998 – 2004) were enrolled in an extended follow-up study conducted in Seattle (2006 -2008). Serum and OMT specimens were collected and tested using GST-L1 fusion proteins on a Luminex® platform. To optimize sensitivity, a subset of OMT samples were tested twice using different protocols. The incubation time for antigen coated beads with OMT fluid was 1 hour at room temperature for the first test and overnight at 4 C for the second. The sensitivity and specificity of the tests were compared by receiver operating characteristic analysis and the more sensitive test used for testing all sera and OMT samples. RESULTS: Overnight incubation improved assay sensitivity. Using the overnight incubation procedure on OMT collected 8.5 years after enrollment in the monovalent vaccine trial, the average median fluorescence intensity (MFI) among the placebo recipients was 440.2 (95% confidence interval [CI]: 370.5 – 509.9) compared with an MFI of 2,208.2 (95% CI: 1,598.4, 2,818.0) among the vaccine recipients. Although 97.8% of the sera samples from the vaccine recipients tested positive, only 47.5% of OMT samples were positive. Six months after administration of the licensed quadrivalent vaccine, OMT anti-HPV-16 reactivity rose 9.8-fold among the monovalent vaccine recipients, with all OMT specimens testing anti-HPV-16 positive. CONCLUSION: Oral fluid testing has potential as an alternative method to venipuncture in monitoring future HPV vaccination programs.

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