Immunogenicity of Fractional Dose of the HPV Vaccines

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05291871

Enrollment

Registered

2022-03-23

Start date

2022-06-15

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

Keywords

HPV, vaccines

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

Interventions

BIOLOGICALHPV vaccine

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

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, 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.

Design outcomes

Primary

Measure	Time frame	Description
HPV antibody detection after intradermal or intramuscular, fractional one-fifth dose HPV-2 or HPV-9 vaccine immunization	12 months	To describe the changes in vaccine-type HPV antibody detection measured by Luminex assay between baseline and 12 months after vaccination.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORHelen Stankiewicz Karita, MD

University of Washington

Outcome results

None listed

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