Immunogenicity of Fractional Dose of the HPV Vaccines

April 17, 2023 updated by: Anna Wald, University of Washington
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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Virology Research Clinic
  • Phone Number: 1 206 520-4340
  • Email: vrc@uw.edu

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington Virology Research Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

27 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IM Bivalent HPV vaccine
One-fifth fractional dose (0.1 ml) of bivalent HPV vaccine administered intramuscularly
Biological: HPV vaccine
One-fifth dose bivalent HPV Vaccine or One-fifth dose nonavalent HPV Vaccine
Experimental: ID Bivalent HPV vaccine
One-fifth fractional dose (0.1 ml) of bivalent HPV vaccine administered subcutaneously
Biological: HPV vaccine
One-fifth dose bivalent HPV Vaccine or One-fifth dose nonavalent HPV Vaccine
Experimental: IM Nonavalent HPV vaccine
One-fifth fractional dose (0.1 ml) of nonavalent HPV vaccine administered intramuscularly
Biological: HPV vaccine
One-fifth dose bivalent HPV Vaccine or One-fifth dose nonavalent HPV Vaccine
Experimental: ID Nonavalent HPV vaccine
One-fifth fractional dose (0.1 ml) of nonavalent HPV vaccine administered subcutaneously
Biological: HPV vaccine
One-fifth dose bivalent HPV Vaccine or One-fifth dose nonavalent HPV Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV antibody detection after intradermal or intramuscular, fractional one-fifth dose HPV-2 or HPV-9 vaccine immunization
Time Frame: 12 months
To describe the changes in vaccine-type HPV antibody detection measured by Luminex assay between baseline and 12 months after vaccination.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

March 3, 2022

First Submitted That Met QC Criteria

March 17, 2022

First Posted (Actual)

March 23, 2022

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 17, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00014983

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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