RecruitingPhase 4NCT05672927

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

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

Sponsor

The University of Texas Medical Branch, Galveston

Enrollment

618 participants

Start Date

Jan 18, 2023

Study Type

INTERVENTIONAL

Conditions

Human Papillomavirus HPV Infection Immunization

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.

Eligibility

Sex: FEMALEMin Age: 27 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called 9-valent HPV vaccine, 2 doses alternate timing and a biological treatment called 9-valent HPV vaccine, 3 doses standard timing for people with hpv infection, human papillomavirus, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 27 Years to 45 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICAL9-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.

BIOLOGICAL9-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

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NCT05672927

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