Actively Recruiting
Testing RG1-VLP Vaccine to Prevent HPV-related Cancers
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
18
Participants Needed
5
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Testing RG1-VLP Vaccine to Prevent HPV-related Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 60 years
- White blood cell count between 3000/mm^3 and institutional upper limit of normal
- Hemoglobin level between 10 g/dl and institutional upper limit of normal
- Platelet count of at least 100,000/mm^3
- Serum creatinine within normal institutional limits
- Bilirubin level less than or equal to twice the institutional upper limit of normal
- Alanine aminotransferase (ALT) level less than or equal to twice the institutional upper limit of normal
- Aspartate aminotransferase (AST) level less than or equal to twice the institutional upper limit of normal
- Negative for HIV-1 and HIV-2
- Negative for hepatitis B and hepatitis C
- Women of childbearing potential must have a negative pregnancy test and agree to use adequate contraception during the study
- Women unable to bear children due to surgery, sterilization implant placed over 3 months ago, or post-menopausal status are eligible without birth control
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- History of genital warts or treatment for anogenital intraepithelial neoplasia
- Systemic cancer treatment within the prior year
- History of anaphylaxis to vaccines
- Prior vaccination with Gardasil, Gardasil-9, Cervarix, or other HPV vaccines
- Received blood products within 3 months or ongoing plasma donation
- Use of other investigational agents
- Allergic reactions to vaccine components similar to RG1-VLP
- Uncontrolled illnesses or psychiatric/social issues limiting study compliance
- Pregnant or actively breastfeeding women
- Planned receipt of inactivated vaccine within 2 weeks before or after study vaccination
- Planned receipt of live attenuated vaccine within 4 weeks before or after study vaccination
- History of bleeding disorders or use of anticoagulants (except aspirin)
- Diagnosed autoimmune diseases such as rheumatoid arthritis
- Congenital or acquired immunodeficiency
- Collagen vascular disease
- Current use of immunosuppressive drugs (inhaled or topical steroids allowed)
- Unrecovered major infections or recent surgical procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
Withdrawn
2
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Withdrawn
3
Staten Island University Hospital
Staten Island, New York, United States, 10305
Withdrawn
4
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
5
Medical University Vienna
Vienna, Austria, A-1090
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
1
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