Testing RG1-VLP Vaccine to Prevent HPV-related Cancers
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Women, age 18 - 60 years. Because no dosing or adverse event (AE) data is currently available for the use of RG1-VLP in humans, children and adolescents are excluded from this study * White blood cell (WBC) between 3000/mm\^3 - institutional upper limit of normal * Hemoglobin (Hgb) between 10 g/dl - institutional upper limit of normal * Platelets \>= 100,000/mm\^3 * Serum creatinine within institutional normal limits * Bilirubin =\< 2x institutional upper limit of normal * Alanine aminotransferase (ALT) =\< 2x institutional upper limit of normal * Aspartate aminotransferase (AST) =\< 2x institutional upper limit of normal * Human immunodeficiency virus (HIV)-1/HIV-2 negative * Hepatitis B and hepatitis C negative * The effects of RG1-VLP vaccination on the developing human fetus at the proposed doses are unknown. For this reason, all women of childbearing potential will have a pregnancy test and all heterosexually active women must agree to use adequate contracept