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Clinical Trial NCT05291871 for HPV Infection, HPV Vaccine is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Immunogenicity of Fractional Dose of the HPV Vaccines Phase 4 92 Vaccine Study Randomized

Active, not recruiting
Clinical Trial NCT05291871 is designed to study Other for HPV Infection, HPV Vaccine. It is a Phase 4 interventional study that is active, not recruiting, having started on 15 June 2022, with plans to enroll 92 participants. Led by University of Washington, it is expected to complete by 31 December 2026. The latest data from ClinicalTrials.gov was last updated on 27 March 2025.
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
Official Title

Immunogenicity of Fractional Dose of the HPV Vaccines

Conditions
HPV InfectionHPV Vaccine
Other Study IDs
  • STUDY00014983
NCT ID Number
NCT05291871
Start Date (Actual)
2022-06-15
Last Update Posted
2025-03-27
Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
92
Study Type
Interventional
PHASE
Phase 4
Status
Active, not recruiting
Keywords
HPV, vaccines
Primary Purpose
Other
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalIM Bivalent HPV vaccine
One-fifth fractional dose (0.1 ml) of bivalent HPV vaccine administered intramuscularly
HPV Vaccine
One-fifth dose bivalent HPV Vaccine or One-fifth dose nonavalent HPV Vaccine
ExperimentalID Bivalent HPV vaccine
One-fifth fractional dose (0.1 ml) of bivalent HPV vaccine administered subcutaneously
HPV Vaccine
One-fifth dose bivalent HPV Vaccine or One-fifth dose nonavalent HPV Vaccine
ExperimentalIM Nonavalent HPV vaccine
One-fifth fractional dose (0.1 ml) of nonavalent HPV vaccine administered intramuscularly
HPV Vaccine
One-fifth dose bivalent HPV Vaccine or One-fifth dose nonavalent HPV Vaccine
ExperimentalID Nonavalent HPV vaccine
One-fifth fractional dose (0.1 ml) of nonavalent HPV vaccine administered subcutaneously
HPV Vaccine
One-fifth dose bivalent HPV Vaccine or One-fifth dose nonavalent HPV Vaccine
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
12 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
27 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • 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

  • 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.
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Study Responsible Party
Anna Wald, Principal Investigator, Professor: School of Medicine, University of Washington
No contact data.
1 Study Locations in 1 Countries

Washington

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