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Intradermal, Fractional Dose of HPV Vaccines:

Sponsor
University of Washington (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04235257
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
26
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: HPV vaccine
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Immunogenicity of Fractional Dose of the Bivalent and Nonavalent Intradermal HPV Vaccines.
Actual Study Start Date :
Nov 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bivalent HPV vaccine

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

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

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

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

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
27 Years to 45 Years
Sexes Eligible for Study:
All
Accepts 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, 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Washington Virology Research Clinic Seattle Washington United States 98104

Sponsors and Collaborators

  • University of Washington

Investigators

  • Principal Investigator: Helen Stankiewicz Karita, MD, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Helen Stankiewicz Karita, Acting Instructor: School of Medicine Division of Allergy and Infectious Diseases, University of Washington
ClinicalTrials.gov Identifier:
NCT04235257
Other Study ID Numbers:
  • STUDY00008961
First Posted:
Jan 21, 2020
Last Update Posted:
Mar 8, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Papillomavirus Infections

Study Results

No Results Posted as of Mar 8, 2022