Testing a new vaccine to prevent HPV-related cancers in women
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 study is testing a new vaccine to see if it can safely prevent HPV-related cancers in women aged 18 to 45.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | National Cancer Institute (NCI) NIH |
| Locations | 5 sites (Birmingham, Alabama and 4 other locations) |
| Trial ID | NCT05985681 on ClinicalTrials.gov |
What this trial studies
This phase I trial evaluates the safety, side effects, and optimal dosage of the RG1-virus-like particle (VLP) vaccine in women aged 18-45 to prevent cancers associated with human papillomavirus (HPV). The study focuses on assessing the immunogenicity of RG1-VLP, which targets rare HPV types not covered by existing vaccines like Gardasil-9. Participants will receive the vaccine at escalating doses, and various assays will be conducted to measure immune responses. The trial also aims to monitor local antibody responses and the vaccine's safety profile in conjunction with Gardasil-9.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy women aged 18 to 45 who meet specific health criteria.
Not a fit: Patients outside the age range of 18 to 45 or those with certain health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this vaccine could provide enhanced protection against HPV-related cancers for women at risk.
How similar studies have performed: While this approach is novel, other studies have shown promise in developing vaccines targeting HPV-related conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birmingham, Alabama and 4 other locations
- University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States (Withdrawn)
- Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland, United States (Withdrawn)
- Staten Island University Hospital — Staten Island, New York, United States (Withdrawn)
- University of Wisconsin Carbone Cancer Center - University Hospital — Madison, Wisconsin, United States (Recruiting)
- Medical University Vienna — Vienna, Austria (Not_yet_recruiting)
Study contacts
- Principal investigator: Reinhard Kirnbauer — Medical University of Vienna
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.