Clinical Research Directory

Recombinant Human Papillomavirus Nonavalent Vaccine in Preventing Human Papilloma Virus in Younger Healthy Participants

Human papillomavirus (HPV) is a common sexually-transmitted virus which causes infections that usually last only a few months, but sometimes can last a long time and cause cancers of the cervix, vagina, vulva, anus or oropharynx over many years among adults. This phase IIA trial studies how well does the nonavalent HPV vaccine (which can prevent nine different types of HPV) work when given in an alternative dosing schedule to heathy young research participants.

Preventive Human Papillomavirus (HPV) Vaccine Trial in Kidney Transplant Recipients

This phase II trial studies whether the nonavalent human papillomavirus vaccine given to adults prior to kidney transplantation can help the body build and maintain an effective immune response during the post-transplant period when they receive immunosuppressive drugs to prevent transplant rejection. This study will help inform our scientific understanding about vaccine-induced immune responses among immunosuppressed individuals.

Testing RG1-VLP Vaccine to Prevent HPV-related Cancers

This phase I trial tests the safety, side effects, and best dose of RG1-virus-like particle (VLP) in preventing human papillomavirus (HPV)-related cancers in women. RG1-VLP is a vaccine that aims to protect against rare HPV types not targeted by currently approved HPV vaccines. HPV is a common sexually-transmitted infection that can cause certain genital and oral cancers. RG1-VLP contains a protein of HPV type 16 (HPV16) with a slightly different structure than the licensed Gardasil-9 vaccine. Gardasil-9 is approved by the Federal Drug Administration to help protect against diseases caused by some types of HPV. Gardasil-9 also contains 9 different HPV proteins. Both vaccines contain alum to stimulate the immune system. The usual approach for the prevention of HPV-related cancers for patients who are at increased risk is to consider the currently approved HPV vaccine like Gardasil-9, as well as to be followed closely by their doctor to watch for the development of cancer via routine pap smears. This trial may allow researchers to find out whether the RG1-VLP vaccine can safely trigger an immune response against HPV in healthy women and if it is better or worse than the usual approach for the prevention of HPV-related cancers.

Interpersonal Communication Training and Vaccination Workflow Training Alone and in Combination to Improve Communication and Recommendations About HPV Vaccination in Pharmacies, IMPACT HPV Trial

This clinical trial compares usual care to interpersonal communication training and vaccination workflow training, alone or in combination, for improving communication about and recommendations for human papillomavirus (HPV) and other vaccinations in pharmacies. Low HPV vaccination in the United States has placed unvaccinated children at risk of developing cancers as adults that could have been prevented. Pharmacies can be convenient for vaccination because they are open longer hours, have shorter wait times, can see patients without appointments and may cost less. However, many people are not aware that vaccination is available in pharmacies and some pharmacies lack the commitment from staff to vaccinate or may not have protocols in place for vaccination. Proactive communication approaches to recommending HPV vaccination have been shown to be effective in medical offices but have not been tested in the pharmacy setting. Interpersonal communication training incorporates the 5 A's (assess, advice, agree, assist and arrange) behavioral counseling framework to strongly recommend HPV and other vaccines and effectively answer any questions or concerns about vaccination. Vaccination workflow training establishes vaccination decision support strategies that pharmacies use to improve vaccination workflows. Interpersonal communication training and vaccination workflow training alone or in combination may improve communication and recommendations for HPV vaccination and increase HPV vaccination in pharmacies.

HPV-16/18 E6/E7-Specific T Lymphocytes, Relapsed HPV-Associated Cancers, HESTIA

Subjects have a type of cancer that has been associated with an infection with a virus called human papilloma virus (HPV). The cancer has come back, has not gone away after standard treatment or the subject cannot receive standard treatment. This is a research study using special immune system cells called HPVST cells, a new experimental treatment. Investigators want to find out if they can use this type of treatment in patients with HPV-cancers. They have discovered a way to grow large number of HPV-specific T cells from the blood of patients with HPV-cancers. They want to see if these special white blood cells, called HPVST cells, that will have been trained to kill HPV infected cells can survive in the blood and affect the tumor. They will also see if they can make the T cells more active against the HPV-cancers by engineering them to be resistant to the TGF-beta chemical that these HPV-cancers produce. They will grow these HPVST cells from the patient's blood. The purpose of this study is to find the biggest dose of HPVSTs that is safe, to see how long they last in the body, to learn what the side effects are and to see if the HPVSTs will help people with HPV associated cancers. If the treatment with HPVST cells alone proves safe (Group A), additional group of patients (Group B) will receive Nivolumab in addition to HPVST cells in a lymphodepleted environment. Nivolumab is an antibody therapy that helps T cells control the tumor and it is FDA approved for the treatment of certain types of cancers, including Hodgkin's lymphoma. Lymphodepletion will decrease the level of circulating T cells prior to infusion of HPVST cells, thereby giving them room to expand. The purpose of this part of the study is to find out if TGF-beta resistant HPVST cells in combination with Nivolumab are safe, how long they last in the body and if they are more effective than HPVST cells alone in controlling the tumor.

MRI-Guided Brachytherapy in Treating Participants With HPV-Associated Stage IB2-IVA Cervical or Stage II-IVA Vaginal Cancer

This trial studies how well magnetic resonance imaging (MRI)-guided internal radiation therapy (brachytherapy) works in treating participants with human papillomavirus (HPV) associated stage IB2-IV cervical or stage II-IVA vaginal cancer. Using MRI guidance during brachytherapy applicator placement may improve treatment planning in participants with cervical or vaginal cancer.

A Vaccine Promotion Package (TweenVax) to Improve Adolescent HPV Vaccination, TweenVax Trial

This clinical trial compares the effect of a vaccine promotional intervention, TweenVax, to standard of care vaccination promotion practices on rates of human papillomavirus (HPV) vaccination in adolescents. HPV vaccination has been identified as a priority for cancer prevention and control by the Cancer Moonshot Blue Ribbon Panel, which estimated that increasing HPV vaccination rates can prevent 400,000 HPV-related cancers in the next 5-10 years. The goal is for HPV vaccinations to be completed by the age of 13. It has been estimated that only about 16% of adolescents were fully up to date with HPV vaccines by age 13. Strong and consistent provider recommendations have been shown to play an important role in the uptake of vaccines. In addition, education and information received by parents may improve the strength of recommendations by providers. The TweenVax intervention includes practice, provider, parent and patient level education to teach best practices, help with vaccine messaging, and give correct and easy to understand information to parents. Providing practice, provider and parent level access to TweenVax may be more effective than current vaccine promotion practices in improving HPV vaccination rates in adolescents.

Prevention and Early Detection of Cervical Cancer Through Self-Administered Screening

This study examines prevention and early detection of cervical cancer through self-administration screening of patients in Western Uganda. The cervix is the opening of the uterus or womb, which is the organ that supports babies before they are born. There are simple tests that let doctors know whether or not patients have cells that may become cancer. Some of the tests determine whether patients have an increased risk for cervical disease, but they do not actually confirm that they have it: these are called "screening" tests. This study may help researchers determine how to best deliver cervical cancer prevention services using the HPV test.