Papillomavirus (HPV) Infection

Researchers are evaluating the safety and effectiveness of Papillex4, a dietary supplement, in women diagnosed with cervical intraepithelial neoplasia CIN grades 1 or 2 caused by HPV infection. The study aims to determine whether Papillex4 leads to regression of abnormal cervical cells compared to a placebo over a 180-day period. This randomized, triple-blind, placebo-controlled trial focuses on cervical cell changes confirmed by histology or cytology. Participants will take either Papillex4 or a placebo, each given as two capsules twice daily with food, one dose with the first meal and one with the last meal. The supplement contains various vitamins and natural extracts. The treatment period lasts 180 days, during which participants also complete questionnaires and undergo tests including a PAP smear, HPV testing, and colonoscopy if applicable. Throughout the study, participants are asked to maintain their usual lifestyle habits and attend clinic visits for sample collection and assessments. Researchers will monitor changes in cervical cell status, HPV clearance, immune markers, micronutrient levels, symptom scores, and quality of life measures up to 360 days. Safety is assessed by tracking adverse events during and after the treatment period, with study completion expected by December 2026.

Researchers are evaluating the protective effects, safety, and immune response of an 11-valent recombinant human papillomavirus HPV vaccine in Chinese women aged 18 to 45 years. This Phase III clinical trial involves 13,500 women divided into three age groups to assess the vaccines ability to prevent HPV infections and related cervical lesions. Participants are randomized into experimental and placebo groups to compare outcomes. The trial administers three doses of either the HPV vaccine or a placebo via intramuscular injections into the upper arm deltoid muscle, scheduled at 0, 2, and 6 months. The study uses a double-blind design to ensure unbiased results. The vaccine targets multiple HPV types associated with cervical cancer and related conditions. Participants will undergo follow-up visits including gynecological examinations, pregnancy testing, and monitoring for adverse events. Researchers will measure the incidence of cervical intraepithelial neoplasia CIN and HPV-related lesions, as well as antibody responses at multiple time points after vaccination. The trial includes long-term monitoring up to six years to evaluate vaccine safety and effectiveness.

Researchers are evaluating STAR0602, a selective T cell receptor targeting bifunctional antibody-fusion molecule, in participants with advanced solid tumors that have high antigen levels. This open-label, multicenter Phase 12 study aims to assess the safety, tolerability, and early clinical activity of STAR0602 given alone and in combination with chemotherapy for these tumors, which have limited effective standard treatments. The trial includes participants with unresectable, locally advanced, or metastatic solid tumors, including specific subtypes like NSCLC and colorectal cancer. The study has two parts Phase 1 Dose Escalation and Phase 2 Dose Expansion. In Phase 1, STAR0602 is given intravenously to determine the maximum tolerated dose and safety profile. Phase 2 uses the recommended dose from Phase 1 to further evaluate safety and preliminary effectiveness, measuring tumor responses and disease control. Chemotherapy drugs like Irinotecan and Docetaxel may be combined with STAR0602, and treatments are administered by infusion following defined cycles. Participants will undergo multiple assessments including safety monitoring for adverse events and serious adverse events up to three years. Researchers will measure tumor response rates, duration of response, disease control rate, progression-free survival, and other pharmacokinetic parameters. Study visits will include treatment administration, laboratory tests, and evaluations to track the therapys effects and tolerability over time. The total participation period may extend up to three years for follow-up and monitoring.

This research aims to study the immune response to the nonavalent HPV 9vHPV vaccine in women living with HIV WLWH, a group particularly vulnerable to HPV and cervical cancer. There is limited data on reduced-dose schedules of the 9vHPV vaccine in this population, which is important as the previously used quadrivalent HPV vaccine has been discontinued. The study seeks to inform global strategies for cervical cancer elimination by evaluating different dosing schedules in WLWH aged 18 to 45 years. Participants will be randomly assigned to one of two groups one group will receive three doses of the 9vHPV vaccine following the routine schedule at 0, 2, and 6 months, while the other group will receive two doses at 0 and 6 months, with a third dose at month 12. This design follows current recommendations and allows comparison of immune responses between the routine and extended dosing schedules. During the two-year follow-up, participants will undergo regular assessments to measure immune responses, specifically anti-HPV1618 antibody levels at months 7 and 24. Researchers will also evaluate vaccine safety, effectiveness, and attitudes toward self-collected HPV samples. Surveys will assess vaccine acceptability and comfort. The study includes monitoring for adverse events and aims to provide data to improve HPV vaccination programs for WLWH globally.

Researchers are evaluating whether using lower doses of radiation can reduce side effects when combined with standard chemotherapy in people with HPV-positive throat cancer. This Phase 2 study focuses on patients with hypoxia negative human papilloma virus HPV associated oropharyngeal carcinoma, aiming to improve treatment tolerability while maintaining effectiveness. Chemotherapy drugs involved include cisplatin, carboplatin, 5-fluorouracil 5-FU, paclitaxel, and Abraxane albumin-bound paclitaxel. Participants are assigned to one of four cohorts based on their specific clinical characteristics. Treatments include radiation over three weeks with a total dose of 30 Gy in 2 Gy fractions, combined with chemotherapy regimens varying by cohort. For example, Cohort B receives carboplatin and paclitaxel starting the same week as radiation Cohort C includes induction chemotherapy before radiation and Cohort D focuses on early-stage cases. The study also uses 18F-FMISO PETCT scans for diagnostic imaging before and during treatment to guide therapy. During the study, participants undergo regular assessments including imaging scans, blood tests to evaluate blood counts and organ function, and clinical evaluations to monitor disease status and side effects. Researchers will measure the number of participants experiencing locoregional cancer recurrence over 2 years. Participants must provide informed consent and comply with study procedures, including MRI scans unless contraindicated. The total participation duration varies depending on treatment and follow-up schedules.

Researchers are evaluating whether monitoring HPV circulating tumor DNA ctDNA levels can effectively detect the risk of cancer returning in people with HPV-associated oropharynx cancer HPV-OPC who have recently undergone or are scheduled for surgery. The study aims to determine if this monitoring can guide decisions about radiation therapy and chemotherapy, potentially allowing for delayed or reduced treatment. This is a Phase II trial sponsored by Memorial Sloan Kettering Cancer Center. Participants are divided into two groups. In Arm A, those with rising HPV ctDNA levels after surgery may have radiation therapy delayed until ctDNA becomes detectable, with radiation doses of 50-60 Gy planned. In Arm B, patients typically needing 6 to 6.5 weeks of chemoradiation may receive a shorter, 3-week course of radiation with concurrent chemotherapy. Both arms involve detailed imaging with FDG PETCT scans for treatment planning and to check for cancer spread. Throughout the study, participants will undergo blood tests to measure HPV ctDNA, imaging scans, and complete questionnaires assessing quality of life and financial impact. Researchers will track progression-free survival over two years, along with detailed monitoring of treatment effects. Treatment is personalized based on ctDNA results and pathology findings, with ongoing assessments for safety and effectiveness during follow-up visits.

Researchers are evaluating the effect of the 9-valent HPV vaccine 9vHPVGardasil-9 on reducing the infectivity and transmission of Human Papillomavirus HPV types 16 andor 18 in women who test positive for these types in cervical, oral, and anal samples. This non-randomized, open-label Phase 4 study aims to show that a 3-dose vaccination regimen can lower the ability of HPV to infect cells and be passed to sexual partners, based on the production of specific antibodies triggered by the vaccine. Secondary goals include measuring antibody levels for all nine HPV types covered by the vaccine and assessing infectivity reduction after one or two doses as well. Participants receive the 9vHPV vaccine in a three-dose series given by intramuscular injection on Day 1, Month 2, and Month 6. The study includes two cohorts women aged 35 or older without or with mild cervical lesions CIN 12 eligible for conservative treatment, and women aged 27 or older with multiple cervical, vulvar, or anal lesions also eligible for conservative treatment. All participants undergo vaccination and sample collection at four scheduled visits over about seven months. During the study, participants will provide cervical, anal, oral, and blood samples at Visits 1, 2, and 3 before vaccination and at Visit 4 after vaccination completion. Additional procedures include a urine pregnancy test at the first visit and completion of health and sexual activity questionnaires at Visits 1 and 4. Researchers will analyze viral infectivity using a cellular assay, measure antibody levels, detect HPV virions and DNA, and perform genotyping. The studys main outcome is the change in HPV infectivity before and after vaccination, with all monitoring and assessments completed within a seven-month period.

Researchers are evaluating the safety and immune response of a new potential treatment called Lenti-HPV-07 for patients with cancers caused by Human Papilloma Virus HPV, specifically cervical or oropharyngeal cancers. The study aims to determine if the treatment is safe and whether it stimulates the immune system. Participants will be grouped based on their cancer type, either recurrentmetastatic or newly diagnosed locally advanced cancer. Participants in this trial will receive Lenti-HPV-07 through intramuscular injections. Those with recurrent or metastatic cancer receive two injections one month apart, while newly diagnosed participants receive one injection before starting standard treatments such as surgery, radiation, or chemotherapy. After treatment, participants will be followed for up to one year through clinic visits or phone calls to monitor their health. During the study, participants will undergo safety and immune response assessments, including monitoring side effects and immune markers for up to 12 months after the last injection. Researchers will also evaluate other factors such as PD-L1 expression. The total participation includes treatment administration followed by quarterly follow-up visits or calls for one year to gather data on safety, immune response, and preliminary treatment effects.

Human Papillomavirus HPV infection is the most common sexually transmitted infection worldwide and is linked to approximately 4.5% of all cancers, including most cervical, vaginal, and anal cancers. Women with a history of high-grade HPV-induced gynecological lesions may have an increased risk of developing anal cancer. This research aims to study proctological follow-up for women at risk, based on age, smear results, and HPV tests, to better understand and manage the development of HPV-related anal lesions. This observational study proposes a proctology follow-up protocol for women considered at risk due to their history of high-grade HPV-induced gynecological lesions. The follow-up frequency is tailored according to the patients age and risk factors, occurring every 3 years, 5 years, or annually. The study will observe patients participating in this follow-up to gather data on the risk of developing HPV-induced lesions and to develop a screening and anal follow-up model. Participants will undergo regular proctological examinations and follow-ups as part of the protocol. Researchers will monitor the risk of developing HPV-related lesions over time and assess the effectiveness of the proposed screening model. The study will measure outcomes during the first year and includes ongoing surveillance to improve clinical recommendations. Participants data and health will be observed without intervention, with the study extending until the end of 2032.

Researchers are evaluating artesunate ointment in a phase II, double-blind, placebo-controlled, randomized study for adults with biopsy-confirmed anal high-grade squamous intraepithelial lesions anal HSIL who are HIV-negative. The study aims to assess the complete and partial tissue response to the ointment, as well as evaluate viral clearance and safety. Anal HSIL is related to HPV infection and requires effective treatment options to prevent progression. Participants are randomly assigned in a 21 ratio to receive either artesunate ointment or placebo. Both groups apply four 5-day cycles of ointment at weeks 0, 2, 4, and 6. Follow-up includes anoscopy or high-resolution anoscopy HRA visits at weeks 8, 18, 30, and 42. Those showing partial or complete response at week 18 continue follow-up with HRA at week 30. Non-responders at week 18 receive standard ablation treatment. During the study, participants undergo regular anoscopy or HRA exams to monitor lesion response and viral clearance. Safety is closely monitored throughout. Participants with persistent anal HSIL at weeks 30 or 42 follow standard care procedures. The primary outcome is the histopathologic response by week 18, with secondary outcomes including HPV clearance and response persistence through week 42. The total study period extends up to 42 weeks, with ongoing safety evaluation.