Status:
ACTIVE_NOT_RECRUITING
Immunogenicity of Fractional Dose of the HPV Vaccines
Lead Sponsor:
University of Washington
Conditions:
HPV Infection
HPV Vaccine
Eligibility:
All Genders
27-45 years
Phase:
PHASE4
Brief Summary
This randomized phase IV trial compares intramuscular and intradermal fractional dose of bivalent HPV vaccine to fractional dose of nonavalent HPV vaccine among men and women aged 27-45 years in Seatt...
Eligibility Criteria
Inclusion
- Age 27-45 years at enrollment
- Not intending to receive the HPV vaccine series for the duration of the study participation
- Willing and able to: provide written informed consent, undergo clinical evaluation, adhere to follow-up schedule
Exclusion
- Prior immunization with HPV-vaccine (Cervarix, Gardasil-4, Gardasil-9)
- Currently pregnant or breastfeeding
- Immunedeficiency disease/condition or cancer that causes clinically significant immunosuppression
- Known HIV infection
- Chemotherapy (current or within 12 months) or currently taking a medication that causes clinically significant immunosuppression.
- Unstable medical condition (e.g., malignant hypertension, poorly controlled diabetes)
- Known allergy to vaccine components
- Prior history of HPV-associated cancer
- Any medical condition which, in the opinion of the investigator, may compromise the subject's ability to safely complete the study.
Key Trial Info
Start Date :
June 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT05291871
Start Date
June 15 2022
End Date
December 31 2026
Last Update
March 27 2025
Active Locations (1)
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1
University of Washington Virology Research Clinic
Seattle, Washington, United States, 98104