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RECRUITING
NCT05672927
PHASE4

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

Sponsor: The University of Texas Medical Branch, Galveston

View on ClinicalTrials.gov

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.

Official title: Comparison of the Immune Response After Administration of 2 vs. 3 Doses of the FDA-approved 9-Valent HPV Vaccine Among Women 27-45 Years of Age

Key Details

Gender

FEMALE

Age Range

27 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

618

Start Date

2023-01-18

Completion Date

2027-08

Last Updated

2025-10-06

Healthy Volunteers

Yes

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.

Locations (1)

University of Texas Medical Branch

Galveston, Texas, United States