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RECRUITING
NCT05985681
PHASE1

Testing RG1-VLP Vaccine to Prevent HPV-related Cancers

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2025-02-27

Completion Date

2027-06-01

Last Updated

2026-04-09

Healthy Volunteers

Yes

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample and vaginal swab collection

BIOLOGICAL

HPV16 RG1 VLP Vaccine

Given IM

OTHER

Questionnaire Administration

Ancillary studies

BIOLOGICAL

Recombinant Human Papillomavirus Nonavalent Vaccine

Given via injection

Locations (5)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Staten Island University Hospital

Staten Island, New York, United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States

Medical University Vienna

Vienna, Austria