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Cancer Vaccine

HPV Vaccine Comparison for Human Papillomavirus

Phase 4
Waitlist Available
Led By Anna Wald, 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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial is comparing two different HPV vaccines to see which is more effective in men and women aged 27-45.

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 follow the trial schedule. People with immune issues, cancer treatments, HIV risk without recent negative tests, unstable health conditions like severe hypertension or uncontrolled diabetes, a history of HPV-related cancer, pregnancy or breastfeeding, or allergies to vaccine ingredients can't join.
What is being tested?
The study compares two fractional doses of different HPV vaccines: bivalent versus nonavalent. Participants' immune responses are checked over two years at specific intervals (baseline, after 4 weeks, then at 6 months, 12 months and finally at 24 months).
What are the potential side effects?
While not specified here, common side effects from HPV vaccines may include pain at injection site, swelling/redness where shot was given; less commonly fever or headache might occur.

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 fractional HPV vaccination

Awards & Highlights

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.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Nonavalent HPV vaccineExperimental Treatment1 Intervention
One-fifth fractional dose (0.1 ml) of nonavalent HPV vaccine administered subcutaneously
Group II: 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
~8003860

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,824 Previous Clinical Trials
1,913,315 Total Patients Enrolled
Anna Wald, MDPrincipal InvestigatorUniversity of Washington
Helen Stankiewicz Karita, MDPrincipal InvestigatorUniversity of Washington
1 Previous Clinical Trials
92 Total Patients Enrolled

Media Library

HPV vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04235257 — Phase 4
Human Papillomavirus Vaccines Research Study Groups: Nonavalent HPV vaccine, Bivalent HPV vaccine
Human Papillomavirus Vaccines Clinical Trial 2023: HPV vaccine Highlights & Side Effects. Trial Name: NCT04235257 — Phase 4
HPV vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04235257 — Phase 4
~0 spots leftby Dec 2024
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