Back to resultsImmunogenicity of Fractional Dose of the HPV Vaccines
Primary Purpose
HPV Infection, HPV Vaccine
Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
HPV vaccine
Sponsored by
About this trial
This is an interventional other trial for HPV Infection focused on measuring HPV, vaccines
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, 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.
Sites / Locations
- University of Washington Virology Research Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
IM Bivalent HPV vaccine
ID Bivalent HPV vaccine
IM Nonavalent HPV vaccine
ID Nonavalent HPV vaccine
Arm Description
One-fifth fractional dose (0.1 ml) of bivalent HPV vaccine administered intramuscularly
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 intramuscularly
One-fifth fractional dose (0.1 ml) of nonavalent HPV vaccine administered subcutaneously
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05291871
Brief Title
Immunogenicity of Fractional Dose of the HPV Vaccines
Official Title
Immunogenicity of Fractional Dose of the HPV Vaccines
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 2024 (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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HPV Infection, HPV Vaccine
Keywords
HPV, vaccines
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IM Bivalent HPV vaccine
Arm Type
Experimental
Arm Description
One-fifth fractional dose (0.1 ml) of bivalent HPV vaccine administered intramuscularly
Arm Title
ID Bivalent HPV vaccine
Arm Type
Experimental
Arm Description
One-fifth fractional dose (0.1 ml) of bivalent HPV vaccine administered subcutaneously
Arm Title
IM Nonavalent HPV vaccine
Arm Type
Experimental
Arm Description
One-fifth fractional dose (0.1 ml) of nonavalent HPV vaccine administered intramuscularly
Arm Title
ID 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
One-fifth dose bivalent HPV Vaccine or One-fifth dose nonavalent HPV Vaccine
Primary Outcome Measure Information:
Title
HPV antibody detection after intradermal or intramuscular, fractional one-fifth dose HPV-2 or HPV-9 vaccine immunization
Description
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
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, 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Stankiewicz Karita, 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
Immunogenicity of Fractional Dose of the HPV Vaccines
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