Is NCT05985681 recruiting in Madison, WI?

Yes, NCT05985681 is currently recruiting participants at its Madison, WI location. This human papillomavirus-related carcinoma clinical trial is actively enrolling qualified participants.

Is participation in this Madison clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Human Papillomavirus-Related Carcinoma Clinical Trial in Madison, WI

Q: How do I join the human papillomavirus-related carcinoma clinical trial in Madison?

To join this clinical trial in Madison, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Human Papillomavirus-Related Carcinoma Study in Madison

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.

Sponsor: National Cancer Institute (NCI)

Who Can Participate

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Madison?

Yes, this clinical trial (NCT05985681) has an active research site in Madison, WI that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Human Papillomavirus-Related Carcinoma Treatment Options in Madison, WI

If you're searching for human papillomavirus-related carcinoma treatment options in Madison, WI, this clinical trial (NCT05985681) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Madison research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced human papillomavirus-related carcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all human papillomavirus-related carcinoma clinical trials near you to find additional studies recruiting in your area.

Human Papillomavirus-Related Carcinoma Clinical Trial in Madison, WI

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