Human Papillomavirus (HPV)

The imaging analysis will consist in obtaining quantitative measurements of lesion uptake on the pre- and post-LuPSMA RLT (lesion and whole-body SUVmax, SUVmean and tumor volume) at each time point on all PET/CT scans. PET metrics at the lesion- and whole-body level will be compared among different PET radiopharmaceuticals at the same time point, and changes over time will be assessed. All patients will be followed-up at our institution and clinical outcome will be correlated to the imaging analysis assessment.

Researchers are evaluating MDNA11, a long-acting "beta-only" recombinant interleukin-2 designed to activate immune cells that attack cancer while minimizing stimulation of cells that suppress immunity. This Phase 1/2 open-label study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumor activity of MDNA11 alone or combined with pembrolizumab in patients with advanced or metastatic solid tumors. The study includes dose-escalation and dose-expansion parts for both monotherapy and combination therapy with pembrolizumab. MDNA11 is given intravenously every two weeks with doses ranging from 0.003 to 0.6 mg/kg for monotherapy, while dose ranges for combination therapy are also evaluated. Treatment continues until progression, withdrawal, or loss to follow-up, with tumor assessments by CT or MRI every 8 weeks. Participants will undergo regular imaging scans every 8 weeks to monitor tumor response and safety assessments throughout the 24-month study. Researchers will track recommended doses for expansion, treatment-related adverse events, and overall safety. The study involves up to 115 patients across multiple sites and includes long-term monitoring for up to 24 months.

Researchers are evaluating the effectiveness of Casein Phosphopeptide Amorphous Calcium Phosphate paste (CPP-ACP) alone or combined with a Lasotronix diode laser to treat dentin hypersensitivity (DH). DH is characterized by sharp, short pain from exposed dentin in response to chemical, thermal, or tactile stimuli and commonly affects older adults. This study explores new treatment approaches using laser therapy, which may block pain by altering dentin structure or fluid, with CPP-ACP as a potential desensitizing agent. Participants are divided into four groups: one receiving CPP-ACP paste applied to exposed dentin areas, another treated with the Lasotronix diode laser following its protocol, a combination group receiving both treatments, and a control group with no active treatment. The laser uses a 635nm wavelength for photo-activated therapy and safe bio-stimulation. The study aims to determine which treatment or combination is more effective at reducing dentin hypersensitivity. During the study, researchers will assess treatment effects on dentin hypersensitivity over a period of up to three months. Participants will be monitored for pain relief and response to stimuli. The study includes follow-ups to evaluate safety and effectiveness, with all treatments and assessments conducted according to protocol. The total participation duration covers the treatment and observation period needed to measure outcomes.

Researchers are evaluating the safety and effectiveness of Papillex4 in treating abnormal cervical cells caused by HPV in women diagnosed with cervical intraepithelial neoplasia (CIN) 1 or 2. The study aims to determine if there is a difference in the proportion of participants whose CIN improves based on tissue or cell analysis from the start of the study to day 180 between those taking Papillex4 and those taking a placebo. Participants will be divided into two groups: one receiving Papillex4 and the other receiving a placebo. Both groups will take two capsules twice daily with food, once with the first meal and once with the last meal, for 180 days. The study is randomized, triple-blind, and placebo-controlled. During the study, participants will complete questionnaires, undergo PAP smears, HPV testing, and colonoscopies if applicable. Researchers will monitor changes in cervical cell health from day 0 to day 180 to assess treatment effects. The total study duration for each participant is 180 days, with safety and efficacy being closely observed.

WHIMS (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis Syndrome) is a rare inherited disorder caused by genetic changes that increase the activity of the CXCR4 receptor. This results in mature neutrophils being trapped in the bone marrow, leading to severe neutropenia, which lowers the body's ability to fight infections. Patients with WHIMS often face recurrent infections affecting the skin, soft tissues, sinuses, and lungs, which can cause serious complications like loss of hearing, teeth, and lung function. Current treatments like granulocyte colony stimulating factor (G-CSF) and immunoglobulin supplements are costly and do not fully address all disease aspects, including warts and HPV-related cancers. Researchers are studying Mozobil (plerixafor), a drug approved to mobilize stem cells before transplantation, to see if it can safely and effectively treat neutropenia in WHIMS patients. The study includes a Dose Escalation phase where participants receive increasing doses of Mozobil over five days until their white blood cell counts improve or the maximum dose is reached. Following this, participants may receive an additional Mozobil dose before restarting G-CSF injections. There is also a long-term Chronic Dosing phase where Mozobil is given once or twice daily for up to 60 months. Mozobil is administered by subcutaneous injection or continuous infusion. Participants will undergo initial screening involving medical history, physical exams, questionnaires, heart and lung scans, and blood and urine tests, including viral screenings and neutrophil function tests. Those on G-CSF will pause treatment two days before starting Mozobil. During treatment, blood samples will be regularly collected to monitor safety and response. The main outcomes measured are safety over up to seven years and increases in absolute neutrophil count. Participants will be monitored closely throughout the study, which may last several years depending on the treatment phase.

Researchers are evaluating the protective effects, safety, and immune response of an 11-valent recombinant human papillomavirus (HPV) vaccine called Hansenulapolymorpha in Chinese women aged 18 to 45 years. This Phase III randomized, blinded, placebo-controlled trial involves 13,500 women divided into three age groups: 18-26, 27-35, and 35-45 years. The study aims to assess the incidence of cervical intraepithelial neoplasia grade 2 or higher (CIN2+) associated with various HPV types after vaccination. Participants receive either the 11-valent HPV vaccine or a placebo through intramuscular injections in the upper arm deltoid muscle. The vaccination schedule includes three doses given at 0, 2, and 6 months. The trial compares the vaccine's effects against placebo across the different age groups, following strict immunization timing. During the study, women attend follow-up visits and provide information through diary cards and contact forms. Researchers monitor safety, immune responses, and HPV-related cervical changes, including CIN2+ occurrences one month after the third dose. The trial also includes pregnancy testing before vaccination and requires effective contraception during the study. Total participation includes vaccination and follow-up over approximately six years to evaluate long-term outcomes.

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 adults against shingles caused by the varicella zoster virus. The study will enroll about 26,000 participants to assess how well the vaccine works compared to a placebo and to examine safety and immune response. Participants will receive two injections of either the LZ901 vaccine or a placebo containing an aluminum hydroxide adjuvant on day 0 and day 29. The vaccine is made from a glycoprotein E fusion protein produced in CHO cells, combined with an aluminum hydroxide adjuvant to enhance the immune response. A subgroup of about 3,000 participants will be involved in testing the consistency of different vaccine batches and will receive three different vaccine batches or placebo. This subgroup will be followed for up to 36 months to evaluate immune response persistence. Throughout the study, participants will attend multiple visits including on-site and in-person follow-ups (16 visits for most, 24 for the immunization subgroup). Researchers will perform tests at screening and monitor vaccine efficacy 30 days after full immunization. They will also evaluate safety, immune responses, batch consistency, and the vaccine's effect on reducing the severity and prevention of postherpetic neuralgia. The trial involves detailed monitoring and follow-up over several years to assess long-term outcomes.

This research aims to compare the effectiveness of two treatments, bleomycin injection and cryotherapy, for plantar warts in adults aged 18 to 65 years. The study focuses on evaluating these treatments using dermoscopy, a skin imaging technique, and investigating factors that may influence treatment outcomes. It also examines the safety, economic impact, and quality of life effects of both therapies. Participants are randomly assigned to one of two groups: the Bleomycin Group or the Cryotherapy Group. In the Bleomycin Group, a precise dose of bleomycin diluted with saline is injected directly into the wart, with the amount depending on wart size. In the Cryotherapy Group, liquid nitrogen is applied to freeze the wart twice, each freeze lasting about 10 seconds with a 30-second break. These treatments aim to clear the warts completely. During the study, researchers will monitor participants to assess the rate of complete wart clearance two weeks after treatment ends. They will use dermoscopy to evaluate the warts and collect data for analysis. Participants will be asked to consent to treatment and photography of their warts. The study includes safety monitoring and considers participants' quality of life and economic costs related to treatment throughout the trial period.

Researchers are evaluating whether a personalized chemoradiation therapy approach, which may use a lower dose of radiation, is as effective as the standard chemoradiation therapy for people with HPV-positive throat cancer. The study also aims to see if using a lower radiation dose with standard chemotherapy results in fewer side effects and how both treatment approaches affect participants' quality of life through questionnaires. Participants will receive chemoradiation therapy with either 30 Gy or 70 Gy of radiation combined with standard chemotherapy drugs including cisplatin, carboplatin, and 5-FU. During week two of radiation treatment, patients will undergo a single 18F-FMISO PET scan to monitor their condition. Quality of life will be assessed using questionnaires like EQ-5D-5L, MDADI-HN, and COST-FACIT. Throughout the study, researchers will monitor overall survival over two years. Participants will complete various assessments and questionnaires to measure side effects and quality of life. The study includes careful safety monitoring and follows participants for two years to evaluate treatment outcomes and effects on daily living.

Researchers are evaluating STAR0602, a selective T cell receptor targeting bifunctional antibody-fusion molecule, in an open-label, multicenter Phase 1/2 study involving participants with advanced solid tumors that are rich in antigens. This study aims to assess the safety, tolerability, and preliminary clinical activity of STAR0602 when given as a single intravenous agent. It focuses on patients with unresectable, locally advanced, or metastatic solid tumors, especially those with specific tumor characteristics such as high mutational burden or viral association. The study is divided into two parts: Phase 1 Dose Escalation and Phase 2 Dose Expansion. During Phase 1, participants receive intravenous STAR0602 to determine its safety profile, maximum tolerated dose, and recommended dose for Phase 2. Phase 2 involves administering STAR0602 at the recommended dose to evaluate safety further and assess clinical activity, including tumor response rates and disease control. STAR0602 is given by intravenous infusion, and dosing schedules follow cycle lengths of 28 days. Participants will be closely monitored throughout the study, including assessments of dose-limiting toxicities in the first treatment cycle, adverse events, and serious adverse events over up to three years. Researchers will measure objective tumor responses and other clinical outcomes such as duration of response, disease control rate, and progression-free survival. Safety monitoring includes regular evaluations and long-term follow-up to understand the treatment's impact on advanced solid tumors over time.