Intradermal, Fractional Dose of HPV Vaccines:

University of Washington

Status and phase

Active, not recruiting

Phase 4

Conditions

HPV Infection

HPV Vaccine

Treatments

Biological: HPV vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT04235257

STUDY00008961

Details and patient eligibility

About

This randomized phase IV trial compares 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, 12 months, and 24 months.

Enrollment

40 estimated patients

Sex

All

Ages

27 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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, and adhere to follow-up schedule

Exclusion criteria

Prior immunization with HPV-vaccine (Cervarix, Gardasil-4, Gardasil-9)
Currently pregnant or breastfeeding
Immune deficiency or other immune disorder
HIV infection or continued high risk for HIV; patients at risk for HIV who do not have a negative HIV test in the last 6 months will be excluded
Cancer or chemotherapy (current, within 6 months, or anticipated in the future) except for fully excised non-melanoma skin cancer)
Unstable medical condition (e.g., malignant hypertension, poorly controlled diabetes,
Known allergy to vaccine components
Prior history of HPV-associated cancer