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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am between 27 and 45 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

HPV antibody detection after intradermal or intramuscular, fractional one-fifth dose HPV-2 or HPV-9 vaccine immunization

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,739 Previous Clinical Trials

1,847,836 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

Frequently Asked Questions

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

Has the IM Nonavalent HPV vaccine been given clearance by the FDA?

"We assess the safety of IM Nonavalent HPV vaccine to be a 3, as this is an approved Phase 4 trial."

Answered by AI

Does the age requirement for this experiment preclude those under 60 from participation?

"To be eligible for this trial, applicants must have reached their 27th birthday and not yet turned 45. Furthermore, there are 29 trials currently enrolling minors and 51 studies taking in seniors over 65 years of age."

Answered by AI

Is there still availability for individuals to participate in this clinical trial?

"According to clinicaltrials.gov, this medical trial is no longer accepting patients - the initial posting was on June 15th 2022 and its last update occurred on February 13th 2023. Despite this study's closure, there are a variety of other trials actively recruiting from 110 different sites across the world."

Answered by AI

To whom is eligibility for this research trial extended?

"This research is recruiting 92 individuals between 27 and 45 years old with a current HPV diagnosis, who are willing to forgo receiving the vaccine series during their involvement in this trial. Additionally, participants must be capable of providing written consent, attending clinical evaluations, and meeting follow-up requirements."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Immunogenicity of Fractional Dose of the HPV Vaccines

Anna Wald 2022. "Immunogenicity of Fractional Dose of the HPV Vaccines". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05291871.

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