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Cancer Vaccine

Fractional Dose HPV Vaccine for Human Papillomavirus

Phase 4
Waitlist Available
Led By Helen Stankiewicz Karita, MD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 27-45 years at enrollment
Be between 18 and 65 years old
Must not have
Known HIV infection
Prior immunization with HPV-vaccine (Cervarix, Gardasil-4, Gardasil-9)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial compares the effectiveness of intramuscular and intradermal fractional doses of two HPV vaccines among men and women in Seattle, with immune response assessed over one year.

Who is the study for?
This trial is for men and women aged 27-45 in Seattle who haven't had the HPV vaccine and won't get it during the study. They must be able to give consent, attend follow-ups, and not have HIV, recent chemo or immunosuppression drugs, unstable health conditions like severe high blood pressure or diabetes, a history of HPV cancer, known allergies to vaccine ingredients, or significant immune system diseases.
What is being tested?
The study compares two ways of giving a smaller-than-usual dose of HPV vaccines: one group gets the bivalent vaccine intramuscularly (in the muscle) or intradermally (under the skin), while another gets a fractional dose of nonavalent vaccine. The participants' immune responses are checked over a year at set times after vaccination.
What are the potential side effects?
Possible side effects from fractional doses of HPV vaccines may include local reactions at injection site such as pain and swelling, general symptoms like fever or headache. Serious allergic reactions are rare but can occur especially in those with known allergies to components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 27 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am HIV positive.
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I have been vaccinated with an HPV vaccine.
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I have had cancer linked to HPV before.
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I do not have any uncontrolled serious health conditions.
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I am currently on or recently had chemotherapy, or I'm taking medication that weakens my immune system.
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I have a condition that significantly weakens my immune system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
HPV antibody detection after intradermal or intramuscular, fractional one-fifth dose HPV-2 or HPV-9 vaccine immunization

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Group I: IM Nonavalent HPV vaccineExperimental Treatment1 Intervention
One-fifth fractional dose (0.1 ml) of nonavalent HPV vaccine administered intramuscularly
Group II: IM Bivalent HPV vaccineExperimental Treatment1 Intervention
One-fifth fractional dose (0.1 ml) of bivalent HPV vaccine administered intramuscularly
Group III: ID Nonavalent HPV vaccineExperimental Treatment1 Intervention
One-fifth fractional dose (0.1 ml) of nonavalent HPV vaccine administered subcutaneously
Group IV: ID Bivalent HPV vaccineExperimental Treatment1 Intervention
One-fifth fractional dose (0.1 ml) of bivalent HPV vaccine administered subcutaneously
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HPV vaccine
2013
Completed Phase 4
~3860

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,812 Previous Clinical Trials
1,913,695 Total Patients Enrolled
Helen Stankiewicz Karita, MDPrincipal InvestigatorUniversity of Washington
1 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

HPV vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05291871 — Phase 4
Human Papillomavirus Research Study Groups: ID Bivalent HPV vaccine, IM Nonavalent HPV vaccine, IM Bivalent HPV vaccine, ID Nonavalent HPV vaccine
Human Papillomavirus Clinical Trial 2023: HPV vaccine Highlights & Side Effects. Trial Name: NCT05291871 — Phase 4
HPV vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05291871 — Phase 4
~3 spots leftby Dec 2024
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