Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)

Part of paid clinical trials in Galveston, Texas.

Sponsor
The University of Texas Medical Branch, Galveston
Study ID
NCT05672927
Phase
PHASE4
Status
Recruiting
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Conditions

  • HPV Infection
  • Human Papillomavirus
  • Immunization

Eligibility Criteria

Sex
FEMALE
Age
27 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • 9-valent HPV vaccine, 2 doses alternate timing — BIOLOGICAL
    Evaluate 2 doses of the 9-valent HPV vaccine across a 12-month period following the 1st dose among 27-45-year-old females.
  • 9-valent HPV vaccine, 3 doses standard timing — BIOLOGICAL
    This will be the comparison group for the 2-dose group.

Study Details

The goal of this clinical trial is to compare a 2-dose and 3-dose series of 9vHPV vaccine among 27-45-year-old females to assess if 2 doses elicit a noninferior immune response. Participants will be randomized 1:1 to either the 2-dose group or the 3-dose group and asked to provide 4 blood samples over a period of 12 months. All 2-dose participants will be offered a 3rd dose after the final blood draw,12 months after their initial vaccination.

Key Dates

Start date
Jan 18, 2023
Status verified
Oct 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2027

Study Design

Enrollment
618 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Females, 3-dose standard
    Three doses of the 9-valent HPV vaccine to be administered to the comparison group (27-45 years of age) at 0, 2, and 6 months.
  • Experimental: Females, 2-dose alternative
    Two doses of the 9-valent HPV vaccine to be administered to the experimental group (27-45 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.

Primary Outcome Measure

Short-term human papillomavirus (HPV) type-specific antibody response for type HPV-6 [ Time Frame: Month 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Medical BranchGalvestonTexas77555
Rosalina M Trujillo
[email protected]
409-747-5594

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By research site
University of Texas Medical Branch· Galveston, TX

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