Testing RG1-VLP Vaccine to Prevent HPV-related Cancers

National Cancer Institute (NCI)
Not yet recruiting
ClinicalTrials.gov ID
For more information, see ClinicalTrials.gov NCT05985681
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.
Biospecimen Collection, Questionnaire Administration, HPV16 RG1 VLP Vaccine, Recombinant Human Papillomavirus Nonavalent Vaccine, Saline
Human Papillomavirus-Related Carcinoma
Reinhard Kirnbauer, Richard B. Roden, Lisa M. Barroilhet, Warner K. Huh, Mario R. Castellanos

See list of participating sites