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

NCT05672927 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 22-0243
• Study Type: interventional
• Target: 618
• Locations: 1 country
• Sites: 1

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

Keywords

HPV vaccination; Gardasil 9; Noninferiority trial

Outcome Measures

Primary Outcomes (27)

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

  Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-6, measured as number of participants.

  Month 1

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

  Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-6, measured as number of participants.

  Month 7

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

  Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-6, measured as number of participants.

  Month 12

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

  Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-11, measured as number of participants.

  Month 1

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

  Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-11, measured as number of participants.

  Month 7

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

  Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-11, measured as number of participants.

  Month 12

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

  Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-16, measured as number of participants.

  Month 1

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

  Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-16, measured as number of participants.

  Month 7

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

  Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-16, measured as number of participants.

  Month 12

• Short-term HPV type-specific antibody response for type HPV-18

  Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-18, measured as number of participants.

  Month 1

• Short-term HPV type-specific antibody response for type HPV-18

  Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-18, measured as number of participants.

  Month 7

• Short-term HPV type-specific antibody response for type HPV-18

  Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-18, measured as number of participants.

  Month 12

• Short-term HPV type-specific antibody response for type HPV-31

  Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-31, measured as number of participants.

  Month 1

• Short-term HPV type-specific antibody response for type HPV-31

  Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-31, measured as number of participants.

  Month 7

• Short-term HPV type-specific antibody response for type HPV-31

  Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-31, measured as number of participants.

  Month 12

• Short-term HPV type-specific antibody response for type HPV-33

  Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-33, measured as number of participants.

  Month 1

• Short-term HPV type-specific antibody response for type HPV-33

  Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-33, measured as number of participants.

  Month 7

• Short-term HPV type-specific antibody response for type HPV-33

  Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-33, measured as number of participants.

  Month 12

• Short-term HPV type-specific antibody response for type HPV-45

  Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-45, measured as number of participants.

  Month 1

• Short-term HPV type-specific antibody response for type HPV-45

  Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-45, measured as number of participants.

  Month 7

• Short-term HPV type-specific antibody response for type HPV-45

  Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-45, measured as number of participants.

  Month 12

• Short-term HPV type-specific antibody response for type HPV-52

  Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-52, measured as number of participants.

  Month 1

• Short-term HPV type-specific antibody response for type HPV-52

  Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-52, measured as number of participants.

  Month 7

• Short-term HPV type-specific antibody response for type HPV-52

  Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-52, measured as number of participants.

  Month 12

• Short-term HPV type-specific antibody response for type HPV-58

  Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-58, measured as number of participants.

  Month 1

• Short-term HPV type-specific antibody response for type HPV-58

  Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-58, measured as number of participants.

  Month 7

• Short-term HPV type-specific antibody response for type HPV-58

  Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-58, measured as number of participants.

  Month 12

Study Arms (2)

Females, 3-dose standard

ACTIVE COMPARATOR

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.

Biological: 9-valent HPV vaccine, 3 doses standard timing

Females, 2-dose alternative

EXPERIMENTAL

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.

Biological: 9-valent HPV vaccine, 2 doses alternate timing

Interventions

9-valent HPV vaccine, 2 doses alternate timing BIOLOGICAL

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

Females, 2-dose alternative

9-valent HPV vaccine, 3 doses standard timing BIOLOGICAL

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

Females, 3-dose standard

Eligibility Criteria

• Age: 27 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Has an immunodeficiency or autoimmune disease such as HIV infection, lymphoma, leukemia, lupus, rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.
• 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.
• History of splenectomy
• Known allergies to any vaccine components, including aluminum, yeast or Benzonase.
• Febrile at ≥100°F in the 24 hours prior to vaccination. The patients may be rescheduled for a later date.
• History of thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
• History of \>10 sexual partners in their lifetime at time of enrollment
• Plans to move out of the Galveston/Houston area in the 13 months following study entry.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• Cancer Prevention Research Institute of Texas: collaborator

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

RECRUITING

Related Publications (1)

• Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.

  PMID: 41276263 DERIVED

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Abbey B Berenson, MD, PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abbey B Berenson, MD, PhD

CONTACT

409-772-2417; abberens@utmb.edu

Rosalina M Trujillo

CONTACT

409-747-5594; rmtrujil@utmb.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Vials submitted for assay will be de-identified and labeled only with the study ID number.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 5, 2023
• Study Start: January 18, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: October 6, 2025

Record last verified: 2025-10

Locations

US (1)