Testing RG1-VLP Vaccine to Prevent HPV-related Cancers

Conditions

• Human Papillomavirus-Related Carcinoma

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 60 Years

Healthy Volunteers

Accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood sample and vaginal swab collection
• HPV16 RG1 VLP Vaccine — BIOLOGICAL
  Given IM
• Questionnaire Administration — OTHER
  Ancillary studies
• Recombinant Human Papillomavirus Nonavalent Vaccine — BIOLOGICAL
  Given via injection

Study Details

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.

Key Dates

Start date

Feb 27, 2025

Status verified

Mar 2026

Primary completion

Jun 1, 2026

Completion

Jun 1, 2027

Study Design

Enrollment

18 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Arms

• Experimental: Prevention (RG1-VLP, Gardasil-9)
  Patients receive RG1-VLP IM for 3 doses at months 0, 2, and 6 in the absence of unacceptable toxicity. Patients may also receive Gardasil-9 via injection for 3 doses at 6 months after the 3rd study vaccination (month 12), then at months 14 and 18 in the absence of unacceptable toxicity. Patients also undergo blood sample collection on study and may undergo vaginal swab collection on study.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 6 months post-3rd RG1-virus-like particle (VLP) vaccination/saline injection ]

Locations (4)

Find similar trials in Birmingham, AL

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