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Intradermal, Fractional Dose of HPV Vaccines:

Immunogenicity of Fractional Dose of the Bivalent and Nonavalent Intradermal HPV Vaccines.

NCT04235257•University of Washington

Summary

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.

Eligibility

Age

27 - 45 years

Sex

ALL

Healthy Volunteers

Yes

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

Key Dates

Start Date

November 1, 2020

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2026

Last Updated

March 27, 2025

Enrollment

ESTIMATED participants

Conditions

HPV InfectionHPV Vaccine

Interventions

HPV vaccine

BIOLOGICAL

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Intradermal, Fractional Dose of HPV Vaccines:

Inclusion Criteria

Exclusion Criteria

Clinic vs Clinic+Community Outreach HPV Self-Collection to Increase Cervical Screening in Women With HIV

Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR)

To Evaluate the Safety and Immunogenicity of 15-valent HPV Recombinant Vaccine in Chinese People Aged 9-45 Years

HPV Ends Here: Increasing Uptake of the HPV Vaccine

HPV DNA Self-sampling in a General Practitioner's Office.

Immunogenicity and Safety of Quadrivalent HPV Vaccine in Healthy Chinese Female Subjects Aged 9 to 19 Years