RecruitingPhase 4

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

United States618 participantsStarted 2023-01-18

Plain-language 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.

Who can participate

Age range

27 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Females 27-45 years old.
. Ability to give informed consent.
. Has not received any prior doses of the HPV vaccine. This will be verified by the person and state registry (Immtrac), as well as the person's electronic medical record.
. Reliable telephone access for the duration of the project.
. Can read and speak in either English or Spanish.
. Identified source of funding for vaccine such as Medicaid, private health insurance, Texas Healthy Women program, etc.
. Reports consistent use of reliable birth control and plans to continue its use through study month 13.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Short-term human papillomavirus (HPV) type-specific antibody response for type HPV-6

Timeframe: Month 1

Short-term human papillomavirus (HPV) type-specific antibody response for type HPV-6

Timeframe: Month 7

Short-term human papillomavirus (HPV) type-specific antibody response for type HPV-6

Timeframe: Month 12

Short-term HPV type-specific antibody response for type HPV-11

Timeframe: Month 1

Short-term HPV type-specific antibody response for type HPV-11

Timeframe: Month 7

Short-term HPV type-specific antibody response for type HPV-11

Timeframe: Month 12

Short-term HPV type-specific antibody response for type HPV-16

Timeframe: Month 1

Trial details

NCT IDNCT05672927

SponsorThe University of Texas Medical Branch, Galveston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08

Contact for this trial

Abbey B Berenson, MD, PhD

409-772-2417 abberens@utmb.edu

View on ClinicalTrials.gov More Immunization trials

Plain-language summary

Who can participate

Age range

27 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Females 27-45 years old.
. Ability to give informed consent.
. Has not received any prior doses of the HPV vaccine. This will be verified by the person and state registry (Immtrac), as well as the person's electronic medical record.
. Reliable telephone access for the duration of the project.
. Can read and speak in either English or Spanish.
. Identified source of funding for vaccine such as Medicaid, private health insurance, Texas Healthy Women program, etc.
. Reports consistent use of reliable birth control and plans to continue its use through study month 13.

What they're measuring

Short-term human papillomavirus (HPV) type-specific antibody response for type HPV-6

Timeframe: Month 1

Short-term human papillomavirus (HPV) type-specific antibody response for type HPV-6

Timeframe: Month 7

Short-term human papillomavirus (HPV) type-specific antibody response for type HPV-6

Timeframe: Month 12

Short-term HPV type-specific antibody response for type HPV-11

Timeframe: Month 1

Short-term HPV type-specific antibody response for type HPV-11

Timeframe: Month 7

Short-term HPV type-specific antibody response for type HPV-11

Timeframe: Month 12

Short-term HPV type-specific antibody response for type HPV-16

Timeframe: Month 1

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria