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New vaccine aims to block HPV cancers missed by current shots

NCT ID NCT05985681

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 6 times

Summary

This early-stage trial tests a new vaccine called RG1-VLP in 18 healthy women aged 18-60. The vaccine targets HPV types not covered by existing vaccines like Gardasil 9. Researchers will check if it is safe and triggers a strong immune response. If it works, it could help prevent more HPV-related cancers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RG1-VLP vaccine (HPV16 virus-like particle vaccine)
What this could lead to
If successful, this could lead to a vaccine that protects against HPV types not covered by current vaccines, potentially preventing more HPV-related cancers.
What could go wrong
This is a very early Phase 1 trial with only 18 participants, so safety and immune response are still unknown. The vaccine may not work as hoped or could cause unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 18 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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) * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Wisconsin Carbone Cancer Center - University Hospital

    RECRUITING

    Madison, Wisconsin, 53792, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.