Follow‐up of humoral immune response after HPV vaccination using first‐void urine: A longitudinal cohort study

Abstract

AbstractAssessment of humoral immune responses following human papillomavirus (HPV) vaccination currently relies on invasive blood sampling. This longitudinal cohort study explores the usability of first‐void urine as a noninvasive alternative sample for antibody detection. In this study, 58 women receiving three doses of the 9vHPV vaccine within a Gardasil9 (9vHPV) Phase III randomized controlled trial were included. Participants provided paired first‐void urine and blood samples before vaccination (M0), 1 month after the third dose (M7), and ~3 years after the third dose (M43). Type‐specific antibody responses to the 9vHPV types were analyzed in 174 first‐void urine and 172 serum samples using a virus‐like particle‐based IgG multiplex enzyme‐linked immunosorbent assay. Additionally, total human IgG concentrations were determined using the BioPlex assay. At M7, 1 month after complete 9vHPV vaccination, 95%–100% of first‐void urine and 100% of serum samples had detectable concentrations, varying by HPV type. At M43, 84%–100% of first‐void urine and 98%–100% of serum samples had HPV‐specific antibody concentrations. Results show significant Spearman rank correlations between type‐specific HPV‐antibody concentrations for paired first‐void urine and serum at all time points. This study confirms the potential feasibility of utilizing first‐void urine as a noninvasive immunological sample within HPV vaccine trials.