Intradermal, Fractional Dose of HPV Vaccines:

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04235257

Enrollment

Registered

2020-01-21

Start date

2020-11-01

Completion date

2026-12-31

Last updated

2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HPV Infection, HPV Vaccine

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.

Interventions

BIOLOGICALHPV vaccine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

27 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
HPV antibody detection after fractional HPV vaccination	12 months	HPV antibody response after delivery of a single, intradermal, fractional dose of the HPV-2 or HPV-9 vaccines

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAnna Wald, MD

University of Washington

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 6, 2026