Ongoing Clinical Trials for Papilloma Viral Infection
Currently, there are 7 clinical trials underway investigating vaccines and treatments for papilloma viral infection (also known as: Human Papillomavirus Infection, HPV Infection). These studies are testing various HPV vaccines and therapeutic approaches in different populations across Europe, including children, adolescents, adults, and specific at-risk groups. The trials are being conducted in Belgium, Czechia, France, Germany, Italy, Netherlands, Poland, Romania, and Spain.
Clinical trial locations
- Belgium
- Czechia
- France
- Germany
- Italy
- Netherlands
- Poland
- Romania
- Spain
Study on Reducing HPV Infectivity in HPV-Positive Women Using 9vHPV Vaccine
This study is testing the Gardasil 9 vaccine in women who are already positive for HPV types 16 and/or 18. The goal is to see if the vaccine can reduce the virus’s ability to infect and spread through body fluids after vaccination.
Who can participate: Women aged 18 years or older who have tested positive for HPV 16 and/or 18 within the last 10 months are eligible. Participants must be attending routine cervical cancer screening or gynecological visits. Women with no visible cervical lesions or mild cervical lesions, anal HPV positivity without visible lesions, or vulvar premalignant lesions may join. Participants need to provide written consent, reliable contact information, and must plan to stay near the study site throughout the duration of the study.
Who cannot participate: Men are excluded from this study, as it focuses only on women. Additionally, individuals from vulnerable populations who cannot protect their own interests are not eligible.
What the study involves: Participants will receive three doses of the Gardasil 9 vaccine. Samples from the cervix, anus, vulva, urine, and mouth will be collected before and after each vaccine dose to assess how the vaccine affects viral infectivity and antibody production. The study will monitor for any side effects and evaluate the reduction in the virus’s ability to spread.
Investigational treatment: The 9vHPV vaccine (Gardasil 9) is designed to protect against nine types of HPV, including types 16 and 18, which cause the majority of HPV-related cancers. The vaccine stimulates the immune system to produce antibodies that prevent infection.
Study on the Effectiveness of 2LPAPI with Interferon Alfa in Clearing Genital HPV Infections in Patients
This double-blind study is comparing the treatment 2LPAPI with a placebo to see if it can effectively clear high-risk HPV infections over 12 months. The treatment contains multiple active substances including interferon alfa and various immune-modulating compounds.
Who can participate: Women between 25 and 45 years old who can have children and are using effective birth control are eligible. Participants must have had a cervical screening test in the last three years showing normal results or mild abnormalities. Current test results must show normal or mild abnormalities, and participants must have a high-risk HPV diagnosis. A stable sexual relationship is required, and participants must be able to understand and follow study requirements.
Who cannot participate: Men and individuals from vulnerable populations who need extra protection or cannot make decisions for themselves are excluded.
What the study involves: Participants will receive either 2LPAPI granules or a placebo through oral administration. Follow-up visits occur at 6 and 12 months to evaluate the clearance of high-risk HPV infection and assess any changes in cervical screening results. Safety monitoring for adverse events will be ongoing throughout the study.
Investigational treatment: 2LPAPI is a combination treatment containing interferon alfa, ciclosporin A, interleukin-1, interleukin-2, ribonucleic acid, and specific nucleic acids designed to work together to help clear the virus from the body.
Study on the Effectiveness of the 9-Valent HPV Vaccine in Children and Adolescents with Weakened Immune Systems
This study evaluates how well the Gardasil 9 vaccine works in children and adolescents with weakened immune systems, including those living with HIV, organ transplant recipients, or those who have received chemotherapy.
Who can participate: Children and adolescents aged 9 to under 18 years who are willing to sign a consent or assent form are eligible. Those who are HIV positive must be on antiretroviral therapy with an undetectable viral load and a CD4 cell count greater than 200/mm3 for at least six months. Recipients of chemotherapy or organ/stem cell transplants must be referred for immunizations after sufficient immune system recovery.
Who cannot participate: Individuals who are immunosuppressed, meaning their immune system is not working properly, are excluded from this study.
What the study involves: Participants will receive three doses of the Gardasil 9 vaccine according to the recommended schedule. Blood tests will be conducted to measure seroconversion (the development of detectable antibodies) at baseline, month 7, and month 12. Additional assessments may include immune markers like CD4/CD8 ratio and specific T cell responses.
Investigational treatment: The 9-valent HPV vaccine protects against nine different types of HPV and works by helping the body’s immune system recognize and fight the virus if exposed in the future.
Study on the Effectiveness of the HPV Vaccine in Preventing HPV Infections in Men Who Have Sex with Men Aged 19-26 Using Cervarix
This study assesses how well the Cervarix vaccine prevents anal HPV infections caused by types 16 and 18 in men who have sex with men, a group at higher risk for these infections.
Who can participate: Men aged 19-26 years (Group 1) or 21-28 years (Group 2) who have had sexual contact with other men in the last six months are eligible. Participants must be visiting the Sexual Health Clinic in Amsterdam and agree to receive the preventive vaccine. Group 1 participants must plan to stay in or around Amsterdam for two years, be willing to return for vaccination visits and complete an online questionnaire at month 15, and attend a final study visit at month 24.
Who cannot participate: The study specifically recruits healthy men who have sex with men and are not currently infected with HPV. Those from vulnerable populations who cannot make informed decisions are excluded.
What the study involves: Participants will receive the Cervarix vaccine through intramuscular injection. An online questionnaire will be completed at month 15, and a final study visit at month 24 will assess vaccine effectiveness by measuring the presence of HPV-16 and HPV-18. Health monitoring and documentation of any side effects will occur throughout the study.
Investigational treatment: Cervarix is a vaccine designed to protect against HPV types 16 and 18, which are known to cause anal and cervical cancers.
Study on Ureter Imaging with Nizaracianine Triflutate for Patients 18+ Undergoing Abdominopelvic Surgery
This trial tests a medication called nizaracianine triflutate that helps surgeons see the ureters (tubes carrying urine from kidneys to bladder) more clearly during abdominal and pelvic surgeries using special near-infrared light.
Who can participate: Adults aged 18 years or older scheduled for necessary abdominopelvic surgical procedures are eligible. For Phase 2, surgery should last at least two hours and involve working on one or both ureters. For Phase 3, surgery can be any length but one or more ureters should be visible during the procedure. Both ureters must be present and functioning properly. Participants must provide informed consent, and laboratory test results should be normal or clinically insignificant. Women of childbearing potential must have a negative pregnancy test.
Who cannot participate: Individuals outside the specified age range, those from vulnerable populations needing special protection, patients with medical conditions interfering with urinary tract imaging, those unable to follow study procedures, and patients with health conditions deemed unsafe by study doctors are excluded.
What the study involves: The medication nizaracianine triflutate is administered intravenously in up to three divided doses during surgery. The medication causes ureters to glow under near-infrared light, making them easier to identify and avoid damaging. Post-surgery assessments evaluate the medication’s effectiveness and safety, with follow-up visits to determine the optimal dose.
Investigational treatment: Nizaracianine triflutate is a fluorescent imaging agent that emits light when exposed to near-infrared light, helping surgeons clearly see the ureters during surgery.
Study on the 9vHPV Vaccine for Preventing Oral HPV Infections in Men Aged 20-45
This large international study tests whether the Gardasil 9 vaccine can prevent persistent oral infections caused by specific high-risk HPV types in adult men aged 20 to 45 years.
Who can participate: Healthy men between 20 and 45 years old who are in good physical condition are eligible. Participants must have had at least one sexual partner in their lifetime and provide written informed consent. They must agree to provide contact information for follow-up and be able to complete an electronic vaccination report card. For the Extension Study, participants from the placebo group or those who did not complete the vaccination series in the base study may continue.
Who cannot participate: Men with a history of allergic reactions to vaccine components, immune system disorders, currently participating in another clinical trial, severe illness that could interfere with the study, prior HPV vaccination, active infections, substance abuse history, or poorly controlled mental health conditions are excluded.
What the study involves: Participants receive three doses of the 9vHPV vaccine or a saline placebo through intramuscular injection. The second dose is given approximately two months after the first, and the third dose six months after the first. Follow-up visits monitor health and vaccine effects, with participants completing an electronic vaccination report card to track symptoms or side effects. The study continues until 2028 to gather comprehensive long-term data.
Investigational treatment: The 9vHPV vaccine protects against nine types of HPV by helping the body build immunity through virus-like particles that stimulate antibody production without causing disease.
Study on the Safety and Immune Response of 9vHPV Vaccine in Preventing HPV in Boys and Girls Aged 9-14 Compared to Young Women Aged 16-26
This study compares different dosing schedules of the Gardasil 9 vaccine to find the best approach for protecting against HPV-related diseases. It evaluates a 2-dose regimen in younger participants versus a standard 3-dose regimen in young women.
Who can participate: Boys and girls aged 9 to 15 years who have not started sexual activity and do not plan to become sexually active during the vaccination period are eligible. Young women aged 16 to 26 years with no Pap test or only normal results and a lifetime history of 0 to 4 sexual partners may participate. Participants in Cohort 0 must have received one dose of the 9vHPV vaccine at least one year before joining and did not receive a second dose of any HPV vaccine.
Who cannot participate: Individuals with current or past infection with any HPV types included in the study, prior HPV vaccination (except as specified), known allergies to vaccine components, weakened immune systems, pregnancy or plans to become pregnant during the study, medical conditions that might interfere with results or pose risks, and those currently participating in or recently involved in another clinical trial are excluded.
What the study involves: Participants receive the Gardasil 9 vaccine as an intramuscular injection. Those aged 9 to 14 receive a second dose after 12, 24, 36, or 60 months depending on their cohort. Participants aged 16 to 26 receive their second dose 2 months after the first and a third dose 6 months after the first. Regular follow-up visits monitor for side effects and measure immune response through blood tests to check antibody levels against HPV.
Investigational treatment: The 9vHPV vaccine protects against nine types of HPV (types 6, 11, 16, 18, 31, 33, 45, 52, and 58) by stimulating antibody production to prevent infection.
Summary
The seven ongoing clinical trials for papilloma viral infection demonstrate a strong focus on HPV vaccination strategies across different populations and age groups. A notable concentration of studies is taking place in Spain, which hosts three trials, followed by Belgium and the Netherlands with two trials each. The remaining trials are distributed across Czechia, France, Germany, Italy, Poland, and Romania.
The Gardasil 9 (9vHPV) vaccine is the most extensively studied intervention, appearing in five of the seven trials. These studies investigate the vaccine’s effectiveness in diverse populations including women already infected with HPV, immunocompromised children and adolescents, men aged 20-45, and young boys and girls. One trial examines the Cervarix vaccine specifically in men who have sex with men, while another tests the experimental 2LPAPI treatment for clearing existing infections.
The trials address various aspects of HPV prevention and treatment, from optimizing vaccination schedules in different age groups to testing therapeutic approaches in already-infected individuals. Several studies focus on vulnerable or at-risk populations, including immunocompromised individuals and men who have sex with men, reflecting efforts to expand protection to groups most in need of intervention. The research spans from immediate prevention goals to long-term follow-up extending to 2028, providing comprehensive data on vaccine safety, effectiveness, and optimal dosing strategies.