P12-22NON-INVASIVE FIRST-VOID URINE SAMPLING AND ACCEPTABILITY TO MONITOR THE IMPACT OF VACCINATION AGAINST HPV

10. HPV testing
S. Van Keer 1, A. Vorsters 1, S. Biesmans 1, X. Van Ostade 2, T. Wiebren 3, M. Ieven 1, P. Van Damme 1.
1Vaccine & Infectious Disease Institute (VAXINFECTIO), University of Antwerp (Belgium), 2Proteinchemistry, proteomics and epigenetic signaling (PPES), University of Antwerp (Belgium), 3Gynaecological cancer, Antwerp University Hospital (Belgium)

Background / Objectives

Feasibility of first-void urine (FVU) sampling to monitor the impact of HPV vaccination has recently been reported [1]. As limited data are available on sampling preference in vaccinees, we assessed the acceptance of using FVU self-sampling as a monitoring tool in vaccinated and unvaccinated women.


Methods

At the University of Antwerp, 56 FVU samples were collected (Colli-PeeTM, Novosanis) from 19 to 26 year old women (mean: 22.30 ± 2.01 year), from whom 19 were unvaccinated, and 37 were previously vaccinated with the bi- or quadrivalent prophylactic HPV vaccine (NCT02714114). Data regarding acceptability of FVU sampling were gathered through questionnaires. HPV DNA genotyping was performed with the Optiplex HPV genotyping assay (Diamex GmbH) after Amicon filtration (Merck Millipore) and NucliSENS® easyMAG® DNA extraction (bioMérieux) [2]. Statistical analysis was performed using IBM Statistics SPSS software Version 23.


Results

From women who previously used a standard urine cup, had a pap smear taken by a clinician, or had a blood sample taken, respectively 46/50; 28/31; and 42/55 preferred FVU sampling with the Colli-PeeTM device over the other method.

An overall prevalence of HPV types 16/18 of 13% (7/56) was found, with a lower percentage in vaccinated versus unvaccinated subjects, respectively 8% (3/37) and 21% (4/19) (OR: 3.022 (95% CI 0.601-15.203) for being HPV16/18 negative (vaccinated/unvaccinated)). No HPV6/11 was found.

The mean age of first sexual contact in the vaccinated and unvaccinated cohort was respectively 17.54 ± 1.85 and 16.40 ± 1.55 year (p<0.05; unpaired student T-test, equal variances assumed), and the mean age of vaccination was 15.79 ± 1.70 year. Two out of 37 vaccinated, and 4/19 unvaccinated women were not sexually active yet, and all HPV DNA negative. From the 35/37 vaccinated women reporting having sexual contact before, 26/37 were vaccinated before first sexual contact, from whom 3/26 tested HPV16 positive, whereas none of the HPV vaccine types were detected in 9/37 vaccinated women reporting to be sexually active before vaccination. In the unvaccinated cohort reporting having sexual contact before (15/19), 3/15 tested positive for HPV16 and 1/15 for HPV18.


Conclusion

Consistent with previous studies, our study illustrates the acceptance of FVU sampling in this population. In addition, feasibility of FVU to detect HPV DNA in vaccinees was shown. The HPV DNA positives seen in this cohort can partly be explained by the highly-sensitive multiplex assay used, and the “non-sexual” exposure to HPV before start of vaccination [1]. The latter stresses the need of vaccination against HPV in pre-adolescent stage.


References

1.            Franceschi S, Umulisa MC, Tshomo U, Gheit T, Baussano I, Tenet V, et al. Urine testing to monitor the impact of HPV vaccination in Bhutan and Rwanda. Int J Cancer 2016.

2.            Vorsters A, Van den Bergh J, Micalessi I, Biesmans S, Bogers J, Hens A, et al. Optimization of HPV DNA detection in urine by improving collection, storage, and extraction. Eur J Clin Microbiol Infect Dis 2014,33:2005-2014.