Human Papillomavirus (HPV)

Researchers are studying men with metastatic castration-resistant prostate cancer (mCRPC) to understand how different PET/CT scans can predict outcomes during radioligand therapy with 177Lu-PSMA-617. This is an exploratory, prospective study conducted at a single center, focusing on imaging tumor heterogeneity to help assess therapy effects and patient response. The study is designed specifically for Veterans undergoing this treatment. Participants will receive several types of PET/CT scans at different times: before starting LuPSMA radioligand therapy (RLT), and then after the 2nd, 4th, and 6th treatment cycles. These scans include 18F-Fluciclovine PET/CT (Axumin), 18F-DCFPyL PET/CT, and 18F-FDG PET/CT. The 18F-Fluciclovine scans will be performed within seven days of the PSMA PET scans to compare imaging results at each time point. During the study, detailed imaging measures such as lesion uptake and tumor volume will be collected and analyzed over time. Patients will be followed at the institution to correlate these imaging results with clinical outcomes. The main outcome measured is the impact of 18F-Fluciclovine PET/CT on predicting outcomes of the 177Lu-PSMA-617 therapy from enrollment through 34 weeks of treatment.

Researchers are evaluating MDNA11, a long-acting "beta-only" recombinant interleukin-2 designed to activate immune cells that kill cancer while minimizing activation of immunosuppressive cells. This Phase 1/2 study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumor activity of MDNA11 alone or combined with the checkpoint inhibitor pembrolizumab in patients with advanced solid tumors. The study is conducted at multiple sites with regulatory and ethical approvals and includes about 115 patients. The trial has several parts: dose escalation and expansion for MDNA11 monotherapy and for its combination with pembrolizumab. MDNA11 is given intravenously every two weeks with doses adjusted to find the recommended dose for expansion. Tumor assessments using CT or MRI scans happen every 8 weeks to monitor response until disease progression or other study-end criteria occur. Treatment may continue beyond progression under certain conditions. Participants undergo evaluations including tumor imaging, laboratory tests, and safety monitoring over up to 24 months. Researchers measure recommended dose levels, treatment-related adverse events, pharmacokinetics, immune response, and anti-tumor activity such as response rates and progression-free survival. Patients can withdraw anytime, and safety follow-up continues to understand MDNA11's effects alone and with pembrolizumab.

Dentin hypersensitivity (DH) causes sharp, short pain from exposed dentin triggered by chemicals, temperature, or touch. It commonly affects older adults and varies widely in prevalence. This research evaluates the effectiveness of Casein phosphopeptide paste (CPP-ACP) alone or combined with a diode laser called Lasotronix in treating DH, as limited studies have explored this combination. The study involves four groups: one receiving CPP-ACP paste application only, one receiving diode laser therapy only, a third receiving both CPP-ACP and laser treatments, and a control group with no treatment. Lasotronix uses a 635nm wavelength laser designed for safe and effective bio-stimulation and photo-disinfection, while CPP-ACP paste aims to reduce pain by managing dentin sensitivity. Participants aged 25 to 65 with at least one sensitive, vital tooth without decay or defective restoration will be involved. They will undergo treatment and follow-up to assess dentin hypersensitivity over three months. Researchers will monitor pain levels and treatment effects, ensuring safety and adherence to the study protocol throughout the trial period.

Researchers are evaluating the safety and effects of Papillex4, a dietary supplement, on the regression of abnormal cervical cells caused by HPV in women diagnosed with cervical intraepithelial neoplasia (CIN) grades 1 or 2. The main goal is to see if Papillex4 leads to a greater improvement in cervical cell abnormalities compared to a placebo by day 180. Participants will take either Papillex4 or a placebo twice daily for 180 days. Papillex4 contains vitamins, minerals, plant extracts, and other natural substances. Both groups will follow the same dosing schedule with two capsules taken with the first and last meals each day. The study design is randomized and quadruple-blinded, meaning neither participants nor researchers know who receives Papillex4 or placebo. During the study, participants will undergo clinical visits, complete questionnaires, and have cervical cell assessments including PAP smears and HPV tests. Some may have colonoscopy if applicable. Researchers will measure changes in cervical cell abnormalities, HPV clearance, immune markers, micronutrient status, symptom scores, quality of life, and monitor safety events over 180 to 360 days. Participants are expected to maintain their usual lifestyle habits and complete all study activities and visits.

Researchers are studying a rare genetic condition called WHIMS, which causes severe neutropenia, a low white blood cell count that makes it harder for the body to fight infections. WHIMS leads to serious infections and complications like warts and cancers related to human papillomavirus (HPV). This research aims to evaluate the safety and effectiveness of a drug called Mozobil in treating neutropenia in people with WHIMS, exploring doses within the approved range. Participants will receive Mozobil through twice daily subcutaneous injections or continuous infusion using a pump. The study includes a dose escalation phase where doses increase over five days until white blood cell counts improve or the maximum dose is reached. After this, patients may enter a long-term phase receiving Mozobil once or twice daily for up to five years. Treatment will be paused for two days before starting Mozobil if participants are on certain white blood cell stimulating medications. During the study, participants will undergo medical history reviews, physical exams, lung and heart function tests, and blood and urine sampling to monitor safety and effectiveness. Researchers will track white blood cell levels, infection rates, and HPV-related skin lesions. Participants will also provide samples for further analysis and adhere to contraception requirements if applicable. The study may last up to seven years, with ongoing safety and response monitoring throughout.

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 vaccine's 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 the protective efficacy and safety of a recombinant herpes zoster vaccine called LZ901 in healthy adults aged 40 years and older. This phase 3, randomized, double-blind, placebo-controlled trial aims to protect participants against shingles caused by the varicella zoster virus. The vaccine contains a tetramer of VZV glycoprotein E combined with an aluminum hydroxide adjuvant known to enhance immune response and widely used in vaccines worldwide. Participants will receive two doses of either the LZ901 vaccine or a placebo (aluminum hydroxide adjuvant) injected into the upper arm on day 0 and day 29. Around 26,000 participants will be enrolled, including a subgroup of about 3,000 to assess the consistency of immune response across three vaccine batches and monitor persistence of immunity up to 36 months. The study includes four groups: treatment main, placebo main, treatment immunization, and placebo immunization groups. Participants will undergo up to 24 visits depending on their group, including on-site and in-person visits for screening, vaccination, and follow-up assessments. Researchers will monitor vaccine efficacy 30 days after full immunization, track adverse events from immediate to 12 months post-vaccination, and evaluate immune response through antibody tests at multiple time points. The study also explores the vaccine's impact on reducing the severity and occurrence of postherpetic neuralgia in adults 40 years and older.

Researchers are evaluating the effectiveness of two treatments, bleomycin injection and cryotherapy, for plantar warts (Verruca Plantaris). This randomized controlled trial aims to compare how well these treatments work using dermoscopy, as well as assess their safety, economic impact, and effects on quality of life. The study includes adult participants aged 18 to 65 years with diagnosed plantar warts. Participants are randomly assigned to one of two groups: the Bleomycin Group or the Cryotherapy Group. The bleomycin treatment involves injecting a diluted solution directly into the wart based on its size, while the cryotherapy treatment uses liquid nitrogen to freeze the wart twice with a 30-second interval. The effectiveness of each treatment is evaluated two weeks after the treatment ends. During the study, patients will undergo assessments including dermoscopic examination of the warts and photographic documentation of the lesions. Researchers will monitor the complete clearance rate of warts as the primary outcome. Safety and other impacts such as quality of life and cost will also be tracked. The total study duration and specific visit schedules are based on treatment and follow-up timelines ending in mid-2025.

Researchers are evaluating a personalized approach to chemoradiation therapy compared to standard chemoradiation therapy in people with HPV-positive throat cancer. This study aims to find out if using a lower dose of radiation with standard chemotherapy is as effective as the standard radiation dose combined with chemotherapy. The study also looks at whether the lower radiation dose causes fewer side effects and how each treatment affects patients' quality of life, measured through questionnaires. Participants will be randomly assigned to one of two treatment groups. One group receives personalized chemoradiation therapy where radiation dose is adjusted based on tumor hypoxia detected by a special FMISO-PET scan; hypoxia-negative patients receive 30 Gy of radiation, while hypoxia-positive patients receive 70 Gy. The other group receives the standard chemoradiation therapy of 70 Gy radiation regardless of hypoxia status. Both groups receive concurrent chemotherapy as per guidelines. After treatment, a PET/CT scan is done about four months later to check for persistent disease, and further standard care is provided as needed. During the study, participants will undergo the FMISO-PET scan, routine chemotherapy and radiation treatments, and quality of life assessments using specific questionnaires. Researchers will monitor overall survival over two years as the primary outcome. Safety and treatment effects will be evaluated through follow-up scans and clinical assessments. Participation involves regular visits for scans, treatments, and questionnaires, with the study lasting at least two years to assess outcomes.

Researchers are evaluating STAR0602, a selective T cell receptor targeting bifunctional antibody-fusion molecule, in adults with advanced solid tumors that are antigen-rich. This open-label, multicenter Phase 1/2 study aims to assess the safety, tolerability, and preliminary clinical activity of STAR0602 in participants with unresectable, locally advanced, or metastatic solid tumors where standard therapies are not effective or suitable. The study has two parts: Phase 1 Dose Escalation and Phase 2 Dose Expansion. In Phase 1, STAR0602 is given intravenously to determine safety, the maximum tolerated dose, and the recommended dose for Phase 2. In Phase 2, participants receive STAR0602 at the established recommended dose to further evaluate safety and clinical activity. Clinical activity is measured by tumor response rates, duration of response, disease control, and progression-free survival. Participants will receive STAR0602 infusions in cycles lasting 28 days. Researchers will monitor safety by tracking dose-limiting toxicities, adverse events, and serious adverse events for up to three years. Tumor responses and survival outcomes are also assessed over this period. Pharmacokinetic measures and anti-drug antibody formation will be evaluated at specified cycles. The total study duration and follow-up can extend up to three years to gather comprehensive safety and activity data.