Intradermal, Fractional Dose of HPV Vaccines:

HPV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04235257
• Other study ID #: STUDY00008961
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: November 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 27 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• HPV Infection
• HPV Vaccine
• Papillomavirus Infections

Intervention

Biological:
• HPV vaccine
Gardasil 9 Bivalent HPV VLP Vaccine, one-fifth dose Nonavalent HPV VLP Vaccine, one-fifth dose

Locations

Country	Name	City	State
United States	University of Washington Virology Research Clinic	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

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