Intradermal, Fractional Dose of HPV Vaccines:

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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HPV Infection HPV Vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Bivalent HPV vaccine

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

Group Type EXPERIMENTAL

HPV vaccine

Intervention Type BIOLOGICAL

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

Nonavalent HPV vaccine

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

Group Type EXPERIMENTAL

HPV vaccine

Intervention Type BIOLOGICAL

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

Interventions

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HPV vaccine

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

27 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes