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New treatment option for Human Papillomavirus-Related Carcinoma
Official title Testing RG1-VLP Vaccine to Prevent HPV-related Cancers
ClinicalTrials.gov ID: NCT05985681
What this study is testing
What is HPV16 RG1 VLP Vaccine?
HPV16 RG1 VLP Vaccine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for human papillomavirus-related carcinoma.
Also referred to as 16L1-16L2aa17-36-based Vaccine, HPV16 RG1-VLP.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Baltimore, Maryland, United States
- Staten Island, New York, United States
- Madison, Wisconsin, United States
- Vienna, Austria
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Baltimore, Maryland, United States; Staten Island, New York, United States; Madison, Wisconsin, United States; Vienna, Austria. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.