Condition: Human Papillomavirus-Related Carcinoma · Sponsor: National Cancer Institute (NCI)
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.
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
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| University of Alabama at Birmingham Cancer Center | Birmingham, Alabama, United States | Withdrawn |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore, Maryland, United States | Withdrawn |
| Staten Island University Hospital | Staten Island, New York, United States | Withdrawn |
| University of Wisconsin Carbone Cancer Center - University Hospital | Madison, Wisconsin, United States | Recruiting |
| Medical University Vienna | Vienna, Austria | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT05985681