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Human Papillomavirus-Related CarcinomaPhase 1NCT05985681

Testing RG1-VLP Vaccine to Prevent HPV-related Cancers

A Phase 1 study testing Biospecimen Collection, HPV16 RG1 VLP Vaccine and Questionnaire Administration in people with Human Papillomavirus-Related Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Human Papillomavirus-Related Carcinoma
What is being tested?
Biospecimen Collection, HPV16 RG1 VLP Vaccine and Questionnaire Administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
27 Jan 2026to 1 Aug 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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)
  • Eastern Cooperative Oncology Group (ECOG) performance status of =< 1
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

    Lisa M. Barroilhet, barroilhet@wisc.edu

    Reinhard Kirnbauer

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Assess the safety of RG1-virus-like particles (VLP) in healthy 18-60 years old women at 3 escalating doses.

SECONDARY OBJECTIVES:

  1. Determine the immunogenicity of RG1-VLP in healthy 18-60 year old women at 3 escalating doses via the following assays:

Ia. Determine serum antibody responses induced by RG1-VLP vaccination by both human papillomavirus (HPV) 16 L1 VLP and HPV16 L2 RG1-peptide enzyme-linked immunosorbent assay (ELISA). This will be assessed at months 0, 1, 2, 3, 6, 7 and 12; Ib. Determine whether vaccination-induced serum antibody response neutralizes HPV16. This will be assessed at months 0, 1, 2, 3, 6, 7 and 12.

EXPLORATORY OBJECTIVES:

  1. Determine whether vaccination-induced serum antibody response broadly neutralizes high risk (hr) HPV other than HPV16. This will be assessed at months 0, 1, 2, 3, 6, 7 and 12.

II. Determine whether vaccination induces a cell-mediated immune (CMI) response. Peripheral blood mononuclear cells (PBMC) will be isolated at months 0, 1 and 7.

III. Determine whether vaccination-induced serum antibody response upon passive transfer to naive animals, protects mice against hrHPV pseudovirion (PsV) challenge. This will be assessed at months 0 and 7.

IV. Determine whether vaccination results in changes in local antibody titers in vaginal and oral secretions (via oral rinse) and the effects of vaccination on HPV types in optionally-collected vaginal and oral secretions and eyebrow hair samples between months 0, 7 and 12.

  1. Assess the safety of recombinant human papillomavirus nonavalent vaccine (Gardasil-9) in healthy women post-administration of RG1-VLP.

OUTLINE: This is a dose-escalation study of RG1-VLP followed by a dose-expansion study.

Patients receive RG1-VLP intramuscularly (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.

After completion of study treatment, patients are followed up to 6 months post-3rd RG1-VLP vaccination injection or up to 14 days post-3rd Gardasil-9 vaccination.

Being tested
Biospecimen Collection, HPV16 RG1 VLP Vaccine, Questionnaire Administration, Recombinant Human Papillomavirus Nonavalent Vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo blood sample and vaginal swab collection

  • HPV16 RG1 VLP VaccineBiological

    Also called 16L1-16L2aa17-36-based Vaccine, HPV16 RG1-VLP, HPV16-RG1VLPs, RG1-VLP Vaccine

    Given IM

  • Questionnaire AdministrationOther

    Ancillary studies

  • Recombinant Human Papillomavirus Nonavalent VaccineBiological

    Also called Gardasil 9, Nonavalent HPV VLP Vaccine, Recombinant HPV Nonavalent Vaccine, Recombinant Human Papillomavirus 9-valent Vaccine

    Given via injection

Study groups in NCT05985681
Study groupRoleWhat they receive
Prevention (RG1-VLP, Gardasil-9)ExperimentalPatients 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.
Receives: Procedure: Biospecimen Collection; Biological: HPV16 RG1 VLP Vaccine; Other: Questionnaire Administration; Biological: Recombinant Human Papillomavirus Nonavalent Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events

    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."

    Measured: Up to 6 months post-3rd RG1-virus-like particle (VLP) vaccination/saline injection

Secondary outcomes (2)

  1. Determination of serum antibody responses to both human papillomavirus (HPV)16 L1 VLP and to HPV16 L2

    Will be tested for IgG against HPV16 L1 using a VLP-based enzyme-linked immunosorbent assay (ELISA). The HPV16 L2 17-36 peptide will be synthesized and used for an L2 ELISA. A dose response relationship for log antibody response will be tested with a linear mixed model. Will be summarized with frequency and relative frequencies along with 95% confidence intervals by time, vaccine dose group, and visit. As appropriate, Jonckheere-Terpstra or Cochran-Armitage tests will be used to test for dose-response relationships.

    Measured: At months 0, 1, 2, 3, 6, 7, and 12

  2. Determination of whether vaccination-induced serum antibody response neutralizes HPV16

    In vitro HPV pseudovirion (PsV) neutralization assays will be performed for HPV16 and HPV18 and additional PsV types requested by the National Cancer Institute, using an assay specifically developed for sensitivity to L2-specific as well as L1-specific neutralizing antibodies. A dose response relationship with serum neutralizing antibody titer will be tested with linear mixed models or Jonckheere-Terpstra tests as appropriate. Will be summarized with frequency and relative frequencies along with 95% confidence intervals by time, vaccine dose group, and visit. As appropriate, Cochran-Armitage tests will be used to test for dose-response relationships.

    Measured: At months 0, 1, 2, 3, 6, 7, and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2023
  2. Study start27 Jan 2026
  3. Primary completion1 Feb 2028 (estimated)
  4. Study completion1 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05985681
Sponsor's protocol ID
NCI-2023-05780
Other IDs
NCI-2023-05780, N01CN45009-45, UWI20-04-01, UWI20-04-01, P30CA014520, UG1CA242635
Status last verified
Sep 2026
First submitted
2 Aug 2023
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Biospecimen Collection, HPV16 RG1 VLP Vaccine and Questionnaire Administration in people with Human Papillomavirus-Related Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (time frame: Up to 6 months post-3rd RG1-virus-like particle (VLP) vaccination/saline injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05985681.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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