Intradermal, Fractional Dose of HPV Vaccines:

NCT04235257 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: STUDY00008961
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

HPV Infection; HPV Vaccine

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Study Arms (2)

Bivalent HPV vaccine

EXPERIMENTAL

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

Biological: HPV vaccine

Nonavalent HPV vaccine

EXPERIMENTAL

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

Biological: HPV vaccine

Interventions

HPV vaccine BIOLOGICAL

Gardasil 9 Bivalent HPV VLP Vaccine, one-fifth dose Nonavalent HPV VLP Vaccine, one-fifth dose

Bivalent HPV vaccine; 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, and adhere to follow-up schedule

You may not qualify if:

• 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

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

• Anna Wald, 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: January 16, 2020
• First Posted: January 21, 2020
• Study Start: November 1, 2020
• 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)