Immunogenicity of Fractional Dose of the HPV Vaccines

NCT05291871 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: STUDY00014983
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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

Keywords

HPV, vaccines

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

IM Bivalent HPV vaccine

EXPERIMENTAL

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

Biological: HPV vaccine

ID Bivalent HPV vaccine

EXPERIMENTAL

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

Biological: HPV vaccine

IM Nonavalent HPV vaccine

EXPERIMENTAL

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

Biological: HPV vaccine

ID Nonavalent HPV vaccine

EXPERIMENTAL

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

Biological: HPV vaccine

Interventions

HPV vaccine BIOLOGICAL

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

ID Bivalent HPV vaccine; ID Nonavalent HPV vaccine; IM Bivalent HPV vaccine; IM Nonavalent HPV vaccine

Eligibility Criteria

• Age: 27 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington Virology Research Clinic

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Papillomavirus Vaccines

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Helen Stankiewicz Karita, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor: School of Medicine

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 23, 2022
• Study Start: June 15, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)