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Testing RG1-VLP Vaccine to Prevent HPV-related Cancers

NCT05985681 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-05-13

No results posted yet for this 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.

Conditions

  • Human Papillomavirus-Related Carcinoma

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Reinhard Kirnbauer · Medical University of Vienna

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-27
Primary Completion
2026-06-01
Completion
2027-06-01
FDA Drug
Yes

Countries

  • United States
  • Austria

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05985681 on ClinicalTrials.gov