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Cancer Vaccine

RG1-VLP Vaccine for HPV-Related Cancers

Phase 1
Waitlist Available
Led By Reinhard Kirnbauer
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at months 0, 1, 2, 3, 6, 7 and 12
Awards & highlights

Study Summary

This trial tests if a new vaccine can help protect against HPV-related cancers in women. It's compared to the approved Gardasil-9 vaccine and routine pap smears.

Who is the study for?
This trial is for women aged 18-45 with normal blood counts and organ function, not pregnant or breastfeeding, without HPV-related diseases or abnormal Pap smears (if over 25), no history of severe allergies to vaccines, and not on immunosuppressants. Participants must agree to use contraception if they can bear children.Check my eligibility
What is being tested?
The trial tests a new vaccine called RG1-VLP against rare HPV types potentially causing cancer. It's compared with the approved Gardasil-9 vaccine. The study includes questionnaires, biospecimen collection, and uses saline as a control in some participants.See study design
What are the potential side effects?
Possible side effects include typical vaccine reactions like soreness at injection site, fever within 72 hours post-vaccination, allergic responses similar to other vaccines containing alum adjuvant or proteins from HPV type 16.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at months 0, 1, 2, 3, 6, 7 and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and at months 0, 1, 2, 3, 6, 7 and 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Determination of serum antibody responses to both human papillomavirus (HPV)16 L1 VLP and to HPV16 L2
Determination of whether vaccination-induced serum antibody response neutralizes HPV16
Other outcome measures
Determination of whether vaccination induces a cell-mediated immune response
Determination of whether vaccination results in changes in antibody titers in vaginal and oral secretions (via oral rinse), and the effects of vaccination on HPV types in optionally-collected vaginal and oral secretions and eyebrow hair samples
Determination of whether vaccination-induced serum antibody response broadly neutralizes high-risk (hr)HPV other than HPV16
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (RG1-VLP, Gardasil-9)Experimental Treatment4 Interventions
Patients receive RG1-VLP IM for 3 doses at months 0, 2, and 6 in the absence of disease progression or 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 disease progression or unacceptable toxicity. Patients also undergo blood sample collection on study and may undergo vaginal swab collection on study.
Group II: Arm II (saline placebo, Gardasil-9)Placebo Group4 Interventions
Patients receive saline placebo IM for 3 doses at months 0, 2, and 6 in the absence of disease progression or unacceptable toxicity. Patients may also receive Gardasil-9 via injection for 3 doses at 6 months after the 3rd saline injection (month 12), then at months 14 and 18 in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection on study and may undergo vaginal swab collection on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1730

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,634 Total Patients Enrolled
1,393 Trials studying Carcinoma
387,290 Patients Enrolled for Carcinoma
Reinhard KirnbauerPrincipal InvestigatorMedical University of Vienna

Media Library

RG1-VLP Vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05985681 — Phase 1
Carcinoma Research Study Groups: Arm I (RG1-VLP, Gardasil-9), Arm II (saline placebo, Gardasil-9)
Carcinoma Clinical Trial 2023: RG1-VLP Vaccine Highlights & Side Effects. Trial Name: NCT05985681 — Phase 1
RG1-VLP Vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05985681 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any potential risks to utilizing Arm I (RG1-VLP, Gardasil-9)?

"Our Power team assigned a score of 1 to Arm I (RG1-VLP, Gardasil-9) as the safety and efficacy has yet to be thoroughly evaluated in Phase 1 trials."

Answered by AI

Is recruitment for participants in this study still open?

"The information posted on clinicaltrials.gov implies that this trial has ceased actively recruiting patients; the initial posting was made on January 15th 2024 and it underwent its last revision in August 9th 2023. However, 8 other trials are currently looking for participants."

Answered by AI

How extensively is this test being conducted across various sites?

"This clinical trial is available at Johns Hopkins University/Sidney Kimmel Cancer Center in Baltimore, Staten Island University Hospital in Staten Island, and the University of Wisconsin Carbone Cancer Center in Madison alongside another 5 sites."

Answered by AI

To whom is enrollment for this experiment open?

"Eligible candidates for this medical trial must have carcinoma and be between 18 and 45 years old. In total, the study is looking to recruit 33 individuals."

Answered by AI

Is this experiment open to elderly participants aged 80 and above?

"Eligibility requirements state that suitable applicants will be aged between 18 and 45 years old. Additionally, there are 1 trial for minors under the age of 18 and 5 trials specifically for those over 65."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Testing RG1-VLP Vaccine to Prevent HPV-related Cancers
2024. "Testing RG1-VLP Vaccine to Prevent HPV-related Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05985681.
~22 spots leftby Apr 2026
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