Recruiting

Phase 1

RG1-VLP VaccineTesting RG1-VLP Vaccine to Prevent HPV-related Cancers

Sponsor:

National Cancer Institute (NCI)

Code:

NCT05985681

Conditions

Human Papillomavirus-Related Carcinoma

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Biospecimen Collection

HPV16 RG1 VLP Vaccine

Questionnaire Administration

Recombinant Human Papillomavirus Nonavalent Vaccine

Study Details

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.

Conditions

Human Papillomavirus-Related Carcinoma

Study ID

NCT05985681

Start date

Jan 27, 2026

Status verified date

Sep, 2026

Completion date

Aug 1, 2028

Anticipated

Primary completion date

Feb 1, 2028

Anticipated

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Accepted

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 registration
Female post-menopausal (> 1 year since last menses or prior laboratory follicle stimulating hormone (FSH) value per institutional range indicating post- menopausal)
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

Study Design

Enrollment

18 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Prevention (RG1-VLP, Gardasil-9)

Patients receive RG1-VLP IM for 3 doses at months 0, 2, and 6 in the absence of unacceptable toxicity. Patients may also receive Gardasil-9 via injection for 3 doses at 6 months after the 3rd study vaccination (month 12), then at months 14 and 18 in the absence of unacceptable toxicity. Patients also undergo blood sample collection on study and may undergo vaginal swab collection on study.

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

Primary outcome measure

Incidence of adverse events [ Time Frame: Up to 6 months post-3rd RG1-virus-like particle (VLP) vaccination/saline injection ]

Central Contacts and Locations

Locations

University of Wisconsin Carbone Cancer Center - University Hospital

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Lisa M. Barroilhet

barroilhet@wisc.edu

Principal Investigator:

Reinhard Kirnbauer

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-09-08.