Intradermal, Fractional Dose of HPV Vaccines:

Phase 4

Active, not recruiting

• Conditions: HPV Infection; HPV Vaccine
• Interventions: Biological: HPV vaccine

• Registration Number: NCT04235257
• Lead Sponsor: University of Washington

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-16
• Study First Submitted QC: 2020-01-16
• Study First Posted: 2020-01-21
• Study Start: 2020-11-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-14
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bivalent HPV vaccine	HPV vaccine	One-fifth fractional dose (0.1 ml) of bivalent HPV vaccine administered subcutaneously
Nonavalent HPV vaccine	HPV vaccine	One-fifth fractional dose (0.1 ml) of nonavalent HPV vaccine administered subcutaneously

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Washington Virology Research Clinic; 🇺🇸 Seattle, Washington, United States