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Intradermal, Fractional Dose of HPV Vaccines:

Primary Purpose

HPV Infection, HPV Vaccine

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
HPV vaccine
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for HPV Infection

Eligibility Criteria

27 Years - 45 Years (Adult)All SexesAccepts 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

Sites / Locations

  • University of Washington Virology Research Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Bivalent HPV vaccine

Nonavalent HPV vaccine

Arm Description

One-fifth fractional dose (0.1 ml) of bivalent HPV vaccine administered subcutaneously

One-fifth fractional dose (0.1 ml) of nonavalent HPV vaccine administered subcutaneously

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 16, 2020
Last Updated
April 17, 2023
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT04235257
Brief Title
Intradermal, Fractional Dose of HPV Vaccines:
Official Title
Immunogenicity of Fractional Dose of the Bivalent and Nonavalent Intradermal HPV Vaccines.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HPV Infection, HPV Vaccine

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bivalent HPV vaccine
Arm Type
Experimental
Arm Description
One-fifth fractional dose (0.1 ml) of bivalent HPV vaccine administered subcutaneously
Arm Title
Nonavalent HPV vaccine
Arm Type
Experimental
Arm Description
One-fifth fractional dose (0.1 ml) of nonavalent HPV vaccine administered subcutaneously
Intervention Type
Biological
Intervention Name(s)
HPV vaccine
Intervention Description
Gardasil 9 Bivalent HPV VLP Vaccine, one-fifth dose Nonavalent HPV VLP Vaccine, one-fifth dose
Primary Outcome Measure Information:
Title
HPV antibody detection after fractional HPV vaccination
Description
HPV antibody response after delivery of a single, intradermal, fractional dose of the HPV-2 or HPV-9 vaccines
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
27 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Wald, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington Virology Research Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intradermal, Fractional Dose of HPV Vaccines:

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