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Testing RG1-VLP Vaccine to Prevent HPV-related Cancers
Sponsor: National Cancer Institute (NCI)
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.
Official title: A Dose Escalation Phase I Trial of the Safety and Immunogenicity of RG1-VLP, A Candidate Broadly Protective Vaccine for the Prevention of HPV-Associated Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2025-02-27
Completion Date
2027-06-01
Last Updated
2026-04-09
Healthy Volunteers
Yes
Conditions
Interventions
Biospecimen Collection
Undergo blood sample and vaginal swab collection
HPV16 RG1 VLP Vaccine
Given IM
Questionnaire Administration
Ancillary studies
Recombinant Human Papillomavirus Nonavalent Vaccine
Given via injection
Locations (5)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Staten Island University Hospital
Staten Island, New York, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States
Medical University Vienna
Vienna, Austria