Immunogenicity of Fractional Dose of the HPV Vaccines

Phase 4

Active, not recruiting

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

• Registration Number: NCT05291871
• Lead Sponsor: University of Washington

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-03
• Study First Submitted QC: 2022-03-17
• Study First Posted: 2022-03-23
• Study Start: 2022-06-15
• 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: 92

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

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