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NCT Number: NCT04235257

Intradermal, Fractional Dose of HPV Vaccines:

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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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, and adhere to follow-up schedule

Exclusion criteria

  • 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

Treatment and study plan

HPV vaccine

Biological

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

Primary outcomes

  1. HPV antibody detection after fractional HPV vaccination

    Time frame: 12 months

    HPV antibody response after delivery of a single, intradermal, fractional dose of the HPV-2 or HPV-9 vaccines

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

Immunogenicity of Fractional Dose of the Bivalent and Nonavalent Intradermal HPV Vaccines.

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2020
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.

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