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

NCT05672927 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 618

Last updated 2025-10-06

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

9-valent HPV vaccine, 2 doses alternate timing

Evaluate 2 doses of the 9-valent HPV vaccine across a 12-month period following the 1st dose among 27-45-year-old females.

BIOLOGICAL

9-valent HPV vaccine, 3 doses standard timing

This will be the comparison group for the 2-dose group.

Sponsors & Collaborators

  • Cancer Prevention Research Institute of Texas

    collaborator OTHER

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • Abbey B Berenson, MD, PhD · University of Texas

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
27 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-18
Primary Completion
2026-08-31
Completion
2027-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05672927 on ClinicalTrials.gov