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Papilloma clinical trials

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NCT ID: NCT02888418 Not yet recruiting - Cervical Cancer Clinical Trials

Safety and Immunogenicity Study of Human Papilloma Virus Vaccine in Women Aged 9 to 30 and Men Aged 9 to 17

Start date: October 2016
Phase: Phase 1
Study type: Interventional

This study evaluates the safety of Tetravalent recombinant human papilloma virus vaccine (6,11,16,18 type) (Hansenula polymorpha) in women of 9 to 30 years old and men of 9 to 17 years old and preliminarily explore the immunogenicity. 135 people are enrolled in total, including 45 women of 18 to 30 years old and 90 people of 9 to 17 years old. Among the first group, 30 women will be inoculated studied vaccine and 15 women will be inoculated placebo. Among the second group, there are 45 women and 45 men, 30 women and 30 men in vaccine group and 15 women and 15 men in placebo group.

NCT ID: NCT02859454 Completed - Clinical trials for Human Papilloma Virus

Avelumab for People With Recurrent Respiratory Papillomatosis

Start date: August 6, 2016
Phase: Phase 2
Study type: Interventional

Background: Recurrent respiratory papillomatosis (RRP) is a rare disease caused by human papillomavirus. It can cause voice changes, airway compromise, pulmonary lesions, and cancers. Programmed death-ligand 1 (PD-L1) is a protein on cells. It may be able to stop or decrease the immune system s response to viruses such as human papillomavirus. The drug Avelumab interferes with the activity of PD-L1. Researchers want to see if Avelumab treats RRP and study its side effects. Objective: To see if Avelumab works in treating RRP and is safe. Eligibility: People ages 18 and older with aggressive RRP that has not responded to available treatments Design: Participants will be screened with: Medical history Previously collected tumor tissue Physical exam Blood, urine, and heart tests Endoscopy procedure: A small tube with a camera is used to look in the nose, throat, larynx, and upper windpipe. Before starting treatment, participants will have: Endoscopy under anesthesia. A sample of papilloma will be taken. Voice handicap questionnaire Computed tomography (CT) scans Apheresis: An intravenous (IV) is inserted into an arm vein. White blood cells are separated from the rest of the blood and stored for research. The rest of the blood is returned through the same IV or one in the other arm. Participants will get the study drug by IV every 2 weeks for up to 12 weeks. Participants will repeat the previous tests throughout the study. If they respond to treatment, participants will be evaluated every 6 weeks (3 times), then every 12 weeks (3 times), then every 26 weeks (2 times) until their disease progresses. Participants will be evaluated 30 days after their last infusion. They will then be contacted annually.

NCT ID: NCT02854761 Not yet recruiting - Clinical trials for Recurrent Respiratory Papillomatosis

Safety Study of EF-022 in Adults With Recurrent Respiratory Papillomatosis (RRP)

Start date: September 2016
Phase: Phase 1
Study type: Interventional

This study evaluates the safety and tolerability of the investigational drug EF-022 in the treatment of adult patients with Recurrent Respiratory Papillomatosis (RRP). Patients will be administered EF-022, either intramuscular or subcutaneous, for a period of 6 months. Preliminary effect of the drug on the disease will be evaluated by following the number and severity of the lesions in the respiratory tract and the effect on voice changes.

NCT ID: NCT02841631 Recruiting - Clinical trials for Human Papillomavirus, Palatine Tonsil

Investigation Into the Infectivity Levels of Human Papilloma Virus (HPV) in Tonsillar Tissue

Start date: July 1, 2018
Phase:
Study type: Observational

Human Papilloma Virus (HPV) has been shown to be a cause of Head & Neck Squamous Cell Carcinoma (HNSCC) and the majority of current studies focus on what is happening in patients with a HPV HNSCC. But there is limited investigation into HPV infection in the oropharynx of patients who do not have HNSCC. The current incidence of oral HPV infection is not known in the general population locally and there is also limited information on what particular localities within the mouth that patients' harbour HPV infection what strains are present and if there are any differences in viral load. Therefore the aim of this project is to investigate within patients that undergo tonsillectomies the rate of HPV infection in tonsils to determine the amount of HPV present within the community.

NCT ID: NCT02834637 Active, not recruiting - Clinical trials for Human Papilloma Virus

A Dose Reduction Immunobridging and Safety Study of Two HPV Vaccines in Tanzanian Girls

DoRIS
Start date: February 23, 2017
Phase: Phase 3
Study type: Interventional

Cervical cancer is the most common cancer in women aged 15-44 years in East Africa, and mortality rates are very high. HPV vaccines are most effective if given to girls who have not yet acquired HPV infection. In Tanzania, HPV vaccine has been shown to be safe, acceptable and can be delivered with high coverage (~80%). However, the cost of delivering HPV vaccine is considerably higher than costs for traditional infant/child vaccinations. This is primarily because of costs to establish outreach programmes and associated personnel costs including nurses who must spend significant time away from their posts to deliver vaccine, especially if multiple doses are needed. There is global interest in simplifying HPV vaccine delivery by reducing the number of doses. If a single dose could be given, this could halve the costs of delivery, making it more accessible to the populations that need it most. Recently, the WHO recommended that 2 doses of HPV vaccine could be given to young girls, based on studies in high and upper middle-income countries. However in Africa high rates of infections like malaria and worms can affect immune responses to vaccines. It is essential to know that reducing the number of doses does not reduce the protective immune response of these vaccines. The investigators are conducting a trial in Tanzanian girls aged 9-14 years to establish whether a single dose of HPV vaccine produces immune responses that are likely to be effective in preventing cervical cancer. Two different HPV vaccines, the bivalent (2-v) vaccine that protects against HPV 16/18 (the cause of 70% of cancers) and the 9-valent (9-v) vaccine that protects against 9 HPV types, will be compared. The trial will randomise 900 girls to 6 arms and follow them for 36 months. Girls will receive the 2-v or the 9-v HPV vaccine, as 1, 2 or 3 doses. Girls receiving 1 or 2 doses will be compared with those receiving 3 doses of the same vaccine, to ensure that the reduced dose regimen produces an immune response that is not inferior to 3 doses. Girls in the 1 and 2 dose arms will be enrolled in an extension and followed for up to 9 years, to examine the stability of immune responses. The immune responses in this study will also be compared with results from other countries where the vaccine has been shown to be protective. This will provide information about whether a reduced number of doses is likely to be protective in Africa. This work will be extremely important in informing future HPV vaccination strategies and will be one of the first randomised trials of 1 and 2 doses of any HPV vaccine in Africa.

NCT ID: NCT02830230 Not yet recruiting - Clinical trials for Cervical Inflammation and Human Papilloma Virus Performance

"Performance of HPV DNA Test in Presence of Co-infection With Common RTIs"

Start date: July 2016
Phase: N/A
Study type: Interventional

There is a strong causal association between persisting genital tract infection with Human Papilloma Virus (HPV) and gradual progression of infection to cervical (mouth of uterus) cancer.The robust study from India have shown that single round of HPV DNA screening test to significantly reduce the cervical cancer mortality. The above findings are very encouraging since it demonstrates that a simple and reliable HPV DNA test which is now available in low income countries has a potential to be accepted as primary screening test in future. The cross-sectional studies from developed countries from year 1999-2004 which focused to determine the test characteristics of HPV Hybrid Capture 2 test (HC2) to determine CIN2 and higher grade lesions, reported test sensitivity of 90% to 100% with a mean of 95%. Similarly the cross-sectional studies from developing countries from 1993 to 2003 which have focused on test characteristics of HPV DNA Hybrid capture 2 (HC2) test to determine CIN2 and higher grade lesions has shown a sensitivity in the range of 50% to 91% with an average sensitivity of 79%.Among the developing countries cross-sectional study from India which evaluated test reported sensitivity of only 68.2%. There is a statistical significant difference ( p value = 0.003) of sensitivity of HPV DNA HC2 test between the developed and developing countries to determine CIN2+ Lesions while there is no difference in the specificity. A study that was conducted in Chinese women to detected the prevalence of HPV genotype among women with mucopurulent cervicitis, healthy women and women with Invasive cancer, the author reported a 10% higher failure rates to extract HPV DNA in cases of mucopurulent cervicitis as compared to other two groups. So the study will explore if if the presence of untreated co-infections with STIs/RTIs (Sexually transmitted infections/Reproductive tract infections) resulting in cervical inflammation is somewhere interfering with low sensitivity of HC2 test due to presence of blood and excess mucus associated with the conditions leading to low sensitivity of the test in context to Indian Scenario.

NCT ID: NCT02812056 Withdrawn - Clinical trials for Malignant Neoplasms of Female Genital Organs

Alisertib and TAK-228 in Participants With Human Papilloma Virus (HPV) Associated Malignancies

Start date: September 2016
Phase: Phase 1
Study type: Interventional

The goal of this clinical research study is to find the highest tolerable dose of the combination of alisertib and TAK-228 that can be given to participants with advanced solid tumors that are associated with HPV. Researchers also want to learn if the study drug combination can help to control advanced solid tumors.

NCT ID: NCT02811367 Completed - Clinical trials for Human Papilloma Virus Infection

The HPV Self-test as a Test of Cure in Madagascar

Start date: June 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to find out whether Self-HPV may be an accurate method for the follow-up of women with a history of HPV infection.

NCT ID: NCT02733068 Completed - Clinical trials for Cervical Intraepithelial Neoplasia

A Phase III Study of Human Papillomavirus (HPV)-16/18 Vaccine.

Start date: November 2, 2014
Phase: Phase 3
Study type: Interventional

A Phase III Double Blinded, Randomized Controlled Study to Evaluate Efficacy of Protection Against HPV-16 and 18 Related Diseases, Immunogenicity and Safety of Recombinant Human Papillomavirus Virus-like Particle Vaccine (Type 16 and 18 L1 Proteins, Yeast) in Healthy Females Aged 18-30 Years.

NCT ID: NCT02714114 Completed - Clinical trials for Human Papilloma Virus Infection

Standard Operating Procedures for Anti-HPV (Human Papillomavirus) Antibody Detection in First-void Urine (AB-SOP Study)

AB-SOP
Start date: September 2015
Phase: N/A
Study type: Observational

The aim of the study is to develop robust analytical protocols for first-void urine sample preparation and antibody assays to monitor natural and/or vaccine induced immunity against HPV (Human Papillomavirus).