Recruiting

HPV Doses

Sponsor:

The University of Texas Medical Branch, Galveston

Code:

NCT05672927

Conditions

Immunization

HPV Infection

Human Papillomavirus

Eligibility Criteria

Sex: Female

Age: 27 - 45

Healthy Volunteers: Accepted

Interventions

9-valent HPV vaccine, 2 doses alternate timing

9-valent HPV vaccine, 3 doses standard timing

Study Details

Brief 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

Immunization

HPV Infection

Human Papillomavirus

Study ID

NCT05672927

Start date

Jan 18, 2023

Status verified date

Oct, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 27 - 45

Healthy Volunteers: Accepted

Inclusion criteria:

1. Females 27-45 years old.
2. Ability to give informed consent.
3. 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.
4. Reliable telephone access for the duration of the project.
5. Can read and speak in either English or Spanish.
6. Identified source of funding for vaccine such as Medicaid, private health insurance, Texas Healthy Women program, etc.
7. Reports consistent use of reliable birth control and plans to continue its use through study month 13.

Exclusion criteria:

1. Currently pregnant or plans to become pregnant or donate eggs in the next 13 months. Any subjects with positive pregnancy tests at the initial visit will be disqualified from the study and advised to seek prenatal care.
2. Has an immunodeficiency or autoimmune disease such as HIV infection, lymphoma, leukemia, lupus, rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.
3. Currently receiving treatment or medication that can suppress immune function including radiation therapy, chemotherapy, cyclosporin, leflunomide (Arava), TNF-α antagonists, monoclonal antibody therapies (including rituximab \[Rituxan\]), intravenous gamma globulin (IVIG), antilymphocyte sera, other therapy known to interfere with the immune response, or systemic corticosteroids (by mouth or intramuscular injection). Those using or have used steroids that are inhaled, placed in the eye, applied on the skin, or injected into the joint/soft tissue will be considered eligible for the study.
4. History of splenectomy
5. Known allergies to any vaccine components, including aluminum, yeast or Benzonase.
6. Febrile at ≥100°F in the 24 hours prior to vaccination. The patients may be rescheduled for a later date.
7. History of thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
8. History of >10 sexual partners in their lifetime at time of enrollment
9. Plans to move out of the Galveston/Houston area in the 13 months following study entry.

Study Design

Enrollment

618 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

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.

9-valent HPV vaccine, 3 doses standard timing

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

Primary outcome measure

  • Short-term human papillomavirus (HPV) type-specific antibody response for type HPV-6 [ Time Frame: Month 1 ]
  • Short-term human papillomavirus (HPV) type-specific antibody response for type HPV-6 [ Time Frame: Month 7 ]
  • Short-term human papillomavirus (HPV) type-specific antibody response for type HPV-6 [ Time Frame: Month 12 ]
  • Short-term HPV type-specific antibody response for type HPV-11 [ Time Frame: Month 1 ]
  • Short-term HPV type-specific antibody response for type HPV-11 [ Time Frame: Month 7 ]
  • Short-term HPV type-specific antibody response for type HPV-11 [ Time Frame: Month 12 ]
  • Short-term HPV type-specific antibody response for type HPV-16 [ Time Frame: Month 1 ]
  • Short-term HPV type-specific antibody response for type HPV-16 [ Time Frame: Month 7 ]
  • Short-term HPV type-specific antibody response for type HPV-16 [ Time Frame: Month 12 ]
  • Short-term HPV type-specific antibody response for type HPV-18 [ Time Frame: Month 1 ]
  • Short-term HPV type-specific antibody response for type HPV-18 [ Time Frame: Month 7 ]
  • Short-term HPV type-specific antibody response for type HPV-18 [ Time Frame: Month 12 ]
  • Short-term HPV type-specific antibody response for type HPV-31 [ Time Frame: Month 1 ]
  • Short-term HPV type-specific antibody response for type HPV-31 [ Time Frame: Month 7 ]
  • Short-term HPV type-specific antibody response for type HPV-31 [ Time Frame: Month 12 ]
  • Short-term HPV type-specific antibody response for type HPV-33 [ Time Frame: Month 1 ]
  • Short-term HPV type-specific antibody response for type HPV-33 [ Time Frame: Month 7 ]
  • Short-term HPV type-specific antibody response for type HPV-33 [ Time Frame: Month 12 ]
  • Short-term HPV type-specific antibody response for type HPV-45 [ Time Frame: Month 1 ]
  • Short-term HPV type-specific antibody response for type HPV-45 [ Time Frame: Month 7 ]
  • Short-term HPV type-specific antibody response for type HPV-45 [ Time Frame: Month 12 ]
  • Short-term HPV type-specific antibody response for type HPV-52 [ Time Frame: Month 1 ]
  • Short-term HPV type-specific antibody response for type HPV-52 [ Time Frame: Month 7 ]
  • Short-term HPV type-specific antibody response for type HPV-52 [ Time Frame: Month 12 ]
  • Short-term HPV type-specific antibody response for type HPV-58 [ Time Frame: Month 1 ]
  • Short-term HPV type-specific antibody response for type HPV-58 [ Time Frame: Month 7 ]
  • Short-term HPV type-specific antibody response for type HPV-58 [ Time Frame: Month 12 ]

Central Contacts and Locations

Central contacts

Abbey B Berenson, MD, PhD

409-772-2417abberens@utmb.edu

Rosalina M Trujillo

409-747-5594rmtrujil@utmb.edu

Locations

University of Texas Medical Branch

Recruiting

Galveston, Texas, United States, 77555

Contacts

Rosalina M Trujillo

409-747-5594rmtrujil@UTMB.EDU

More Information

Sponsor

The University of Texas Medical Branch, Galveston

Last update posted

Oct 6, 2025

Last verified

Oct, 2025

Keywords

  • HPV vaccination
  • Gardasil 9
  • Noninferiority trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Medical Branch, Galveston on 2025-10-06.