Immunogenicity of Fractional Dose of the HPV Vaccines

Running, not enrolling · Phase 4

Conditions studied: HPV Infection, HPV Vaccine

In brief

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 Seattle, Washington. Participants will have immune response assessed at baseline, 4 weeks, 6 months, and 12 months

Key facts

Study ID

NCT05291871

Run by

University of Washington

People needed

92

Starts

2022-06-15

Expected to finish

2026-12-31

Last updated by the study team

2026-05-05

Who can join

Age: 27 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Washington Virology Research Clinic — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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