Clinical Research Directory

Epidemiology of Anal Human Papillomavirus Carriage in Female Solid Organ Transplant Recipients With More Than 10 Years of Immunosuppression

Anal canal cancer is primarily associated with persistent infection by high-risk human papillomavirus (HR-HPV), particularly HPV-16. Women who have undergone solid organ transplantation are at increased risk of anal cancer because of the chronic immunosuppression required to maintain graft function. However, epidemiological data regarding the prevalence of anal HPV-16 and other HR-HPV types in this population remain limited and sometimes conflicting. EPAHTOS is a single-center, cross-sectional, observational study (French Category 2 Interventional Research Involving Human Participants \[RIPH 2\]) conducted at Montpellier University Hospital. The study aims to evaluate the prevalence of anal HPV-16 carriage among women aged 18 to 75 years who underwent kidney, liver, and/or heart transplantation more than 10 years previously, or who have received cumulative immunosuppressive therapy for more than 10 years. A total of 190 participants will be enrolled. At the inclusion visit, participants will receive information about the study, provide written informed consent, complete a self-administered questionnaire including questions on HPV infection risk factors, and perform a self-collected anal sample for the detection of high-risk HPV by polymerase chain reaction (PCR). This test allows identification of HPV-16 as well as other HR-HPV genotypes. The primary objective is to estimate the prevalence of anal HPV-16 carriage. Secondary objectives include assessing the distribution of other anal HR-HPV genotypes, describing cytological abnormalities associated with HR-HPV infections, estimating the prevalence of anal histological lesions detected by high-resolution anoscopy among eligible participants, identifying factors associated with HR-HPV carriage, evaluating the feasibility of anal self-sampling, and describing the distribution of cervical HR-HPV infections. In accordance with French recommendations, participants testing positive for HPV-16 will receive standard clinical management including reflex anal cytology and, in the event of a cytological abnormality, referral for proctology consultation with high-resolution anoscopy. Within the framework of the study, participants carrying an HR-HPV genotype other than HPV-16 and presenting abnormal cytology will also be offered standard proctological evaluation to ensure that clinically significant anal lesions are not overlooked. The results of this study will provide updated information on the epidemiology of HPV infections among female solid organ transplant recipients and may contribute to the development of future anal cancer screening strategies in this high-risk population.

Phase I/II Trial of Electroporation-Delivered pBI-4 Vaccine (TriGrid™ PVX4) for Treatment of Women With HPV16-Positive CIN1 or Persistent Infection

The purpose of this study is to evaluate the safety, efficacy, and tolerability of pBI-4, an investigational therapeutic DNA vaccine, in treating adult women with Human Papillomavirus type 16 (HPV16)-positive Grade 1 cervical intraepithelial neoplasia (CIN1) or persistent HPV16 infection. This is a randomized, double-blind, placebo-controlled, multicenter Phase II trial in Taiwan, aiming to enroll a total of 94 female participants. Participants will be randomly assigned (1:1 ratio) to receive either a single 1.0 mg dose of the pBI-4 vaccine or a placebo. The study drug or placebo will be administered intramuscularly in the thigh muscle using the TriGrid™ Delivery System version 2.0 (TDS-IM v2.0), a specialized device that applies short, mild electrical pulses (electroporation) to help cells take up the vaccine and stimulate a stronger immune response. The primary goal of the study is to compare the rate of HPV16 viral clearance between the vaccine and placebo groups at Month 6. The study also features an adaptive design: an interim analysis will be conducted after approximately 50% of participants complete their 6-month assessment. If the initial single-dose regimen shows suboptimal efficacy at the interim stage, the trial may adaptively switch to a two-dose (prime-boost) regimen administered one month apart for the remaining participants. All participants will be closely monitored for safety, side effects, and immune responses for a total duration of 12 months.