NCT05985681 · National Cancer Institute (NCI)
Testing RG1-VLP Vaccine to Prevent HPV-related Cancers
What this study 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 taken by mouth cancers.
View original scientific description
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.
Interventions
PROCEDURE
Biospecimen Collection
Undergo blood sample and vaginal swab collection
BIOLOGICAL
HPV16 RG1 VLP Vaccine
Given IM
OTHER
Questionnaire Administration
Ancillary studies
BIOLOGICAL
Recombinant Human Papillomavirus Nonavalent Vaccine
Given via injection
Primary outcome measures
Incidence of adverse events
Time frame: Up to 6 months post-3rd RG1-virus-like particle (VLP) vaccination/saline injection
Safety of the three escalating doses of RG1-VLP will be assessed by adverse events in terms of severity grade and attribution to vaccination as ordinal outcomes. All toxicities will be tabulated and frequencies and percentages of events will be presented for each vaccine dose cohort. The severity of the adverse events will be assessed using the Common Terminology Criteria for Adverse Events 5.0 and supplemented by Food and Drug Administration "Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials."
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
- The following persons are not considered to be able to bear children and are therefore eligible to participate without the use of concurrent birth control:
- Female with bilateral oophorectomy and/or hysterectomy
- Female with fallopian tubes cut, tied or sealed
- Female with sterilization implant (e.g. Adiana, Essure) placed \> 3 months prior to randomization
- Female post-menopausal (\> 1 year since last menses or prior laboratory follicle stimulating hormone \[FSH\] value per institutional range indicating post-menopausal)
- Eastern Cooperative Oncology Group (ECOG) performance status of =\< 1
- Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
- History of any of the following:
- Prior or current genital warts
- Treatment for anogenital intraepithelial neoplasia (cervical intraepithelial neoplasia \[CIN\], anal intraepithelial neoplasia \[AIN\], vaginal intraepithelial neoplasia \[VAIN\], vulvar intraepithelial neoplasia \[VIN\])
- Systemic cancer treatment within the prior year
- History of anaphylaxis to vaccines
- Any prior vaccination with Gardasil, Gardasil-9, or Cervarix or other HPV vaccine
- Receipt of blood products within 3 months of enrollment, or continuing plasma donation
- Participants receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the adjuvant or to RG1-VLP
- Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements or preclude protocol vaccination
- Pregnant women or actively lactating women are excluded from this study because RG1-VLP is a vaccine with the potential for teratogenic or abortifacient effects
- Planned receipt of any inactivated vaccine in the 2 weeks preceding and the 2 weeks following any trial vaccination
- Planned receipt of any live attenuated vaccine in the 4 weeks preceding and the 4 weeks following any trial vaccination
- Women with a history of bleeding disorders or use of anticoagulants (aspirin is acceptable)
- Had prior medical diagnoses:
- Rheumatoid arthritis or other auto-immune disease
- Congenital or acquired immunodeficiency
- Collagen vascular disease
- Following medical treatments:
- Current use of immunosuppressive drugs including corticosteroid use (inhaled or topical steroids are permitted)
- Unrecovered major infections and/or surgical procedures
Where
- Birmingham, Alabama
- Baltimore, Maryland
- Staten Island, New York
- Madison, Wisconsin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 24, 2026 · Source of record for eligibility and locations