Immunogenicity of Fractional Dose of the HPV Vaccines

Phase 4Active Not RecruitingNCT05291871

University of Washington92 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

HPV Infection HPV Vaccine

Interventions

HPV vaccineBIOLOGICAL

One-fifth dose bivalent HPV Vaccine or One-fifth dose nonavalent HPV Vaccine

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, adhere to follow-up schedule Exclusion Criteria: * 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.

Locations (1)

University of Washington Virology Research Clinic

Seattle, Washington, United States

Outcomes

Primary Outcomes

HPV antibody detection after intradermal or intramuscular, fractional one-fifth dose HPV-2 or HPV-9 vaccine immunization

To describe the changes in vaccine-type HPV antibody detection measured by Luminex assay between baseline and 12 months after vaccination.

Time frame: 12 months

Data from ClinicalTrials.gov

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