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NCT05985681 · ClinicalTrials.gov registry record · Phase 1
Testing RG1-VLP Vaccine to Prevent HPV-related Cancers
A Phase 1 study of Human Papillomavirus-Related Carcinoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 5
- Study locations
NCT05985681: Recruiting Phase 1 study of Human Papillomavirus-Related Carcinoma, sponsored by National Cancer Institute (NCI).
NCT05985681 is a Phase 1 study of Human Papillomavirus-Related Carcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 18 participants, below the 404-participant average among 7 other Human Papillomavirus-Related Carcinoma trials with a reported enrollment target (96% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05985681, a Phase 1 study of Human Papillomavirus-Related Carcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 5
- Study locations
Study 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. 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.
Primary Outcome
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 He
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Questionnaire Administration
- BIOLOGICAL HPV16 RG1 VLP Vaccine
- BIOLOGICAL Recombinant Human Papillomavirus Nonavalent Vaccine
Study Locations (5)
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
New York
- Staten Island University Hospital - Staten Island
Wisconsin
- University of Wisconsin Carbone Cancer Center - University Hospital - Madison
Other
- Medical University Vienna - Vienna
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2025-02-27 |
| Est. Completion | 2027-06-01 |
| Phase | Phase 1 |
What NCT05985681 shows while recruiting
NCT05985681 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 404-participant average among 7 other Human Papillomavirus-Related Carcinoma trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Human Papillomavirus-Related Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Biospecimen Collection is the first listed.
NCT05985681 lists 5 locations in 5 states (Alabama, Maryland, New York).
Frequently Asked Questions
What is clinical trial NCT05985681 about?
NCT05985681 is a clinical study titled "Testing RG1-VLP Vaccine to Prevent HPV-related Cancers". 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 sexua...
What is the current status of trial NCT05985681?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2025-02-27. Estimated completion is 2027-06-01.
What conditions does trial NCT05985681 study?
This clinical trial studies the following conditions: Human Papillomavirus-Related Carcinoma.
What interventions are being tested in trial NCT05985681?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Questionnaire Administration (OTHER), HPV16 RG1 VLP Vaccine (BIOLOGICAL), Recombinant Human Papillomavirus Nonavalent Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05985681?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05985681 being conducted?
This trial has 5 study locations across Alabama, Maryland, New York, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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