Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05291871

Immunogenicity of Fractional Dose of the HPV Vaccines

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

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

Age range

27 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Washington Virology Research Clinic

Seattle, Washington, 98104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HPV vaccine

Biological

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

Primary outcomes

  1. HPV antibody detection after intradermal or intramuscular, fractional one-fifth dose HPV-2 or HPV-9 vaccine immunization

    Time frame: 12 months

    To describe the changes in vaccine-type HPV antibody detection measured by Luminex assay between baseline and 12 months after vaccination.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 23, 2022
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.