Intradermal, Fractional Dose of HPV Vaccines:

Phase 4Active Not RecruitingNCT04235257

University of Washington40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

HPV Infection HPV Vaccine

Interventions

HPV vaccineBIOLOGICAL

Gardasil 9 Bivalent HPV VLP Vaccine, one-fifth dose Nonavalent HPV VLP Vaccine, one-fifth dose

Eligibility

Sex: ALLMin age: 27 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Washington Virology Research Clinic

Seattle, Washington, United States

Outcomes

Primary Outcomes

HPV antibody detection after fractional HPV vaccination

HPV antibody response after delivery of a single, intradermal, fractional dose of the HPV-2 or HPV-9 vaccines

Time frame: 12 months

Data from ClinicalTrials.gov

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