Immunogenicity of Fractional Dose of the HPV Vaccines

NCT ID: NCT05291871

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-15
• Study Completion Date: 2026-12-31

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

Conditions

HPV Infection; HPV Vaccine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

IM Bivalent HPV vaccine

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

Group Type: EXPERIMENTAL

HPV vaccine

Intervention Type: BIOLOGICAL

One-fifth dose bivalent HPV Vaccine or One-fifth dose nonavalent HPV Vaccine

ID Bivalent HPV vaccine

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

Group Type: EXPERIMENTAL

HPV vaccine

Intervention Type: BIOLOGICAL

One-fifth dose bivalent HPV Vaccine or One-fifth dose nonavalent HPV Vaccine

IM Nonavalent HPV vaccine

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

Group Type: EXPERIMENTAL

HPV vaccine

Intervention Type: BIOLOGICAL

One-fifth dose bivalent HPV Vaccine or One-fifth dose nonavalent HPV Vaccine

ID Nonavalent HPV vaccine

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

Group Type: EXPERIMENTAL

HPV vaccine

Intervention Type: BIOLOGICAL

One-fifth dose bivalent HPV Vaccine or One-fifth dose nonavalent HPV Vaccine

Interventions

HPV vaccine

One-fifth dose bivalent HPV Vaccine or One-fifth dose nonavalent HPV Vaccine

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 27 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Anna Wald

Professor: School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helen Stankiewicz Karita, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington Virology Research Clinic

Seattle, Washington, United States

Countries

United States

Other Identifiers

STUDY00014983

Identifier Type: -

Identifier Source: org_study_id