search
Back to results

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

Primary Purpose

Immunization, HPV Infection, Human Papillomavirus

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
9-valent HPV vaccine, 2 doses alternate timing
9-valent HPV vaccine, 3 doses standard timing
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Immunization focused on measuring HPV vaccination, Gardasil 9, Noninferiority trial

Eligibility Criteria

27 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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. Exclusion criteria: 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.

Sites / Locations

  • University of Texas Medical BranchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Females, 3-dose standard

Females, 2-dose alternative

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 19, 2022
Last Updated
October 4, 2023
Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
Cancer Prevention Research Institute of Texas
search

1. Study Identification

Unique Protocol Identification Number
NCT05672927
Brief Title
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2023 (Actual)
Primary Completion Date
August 2026 (Anticipated)
Study Completion Date
August 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
Cancer Prevention Research Institute of Texas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The investigators are studying an alternate dosing regimen of an approved drug (9vHPV vaccine) in the population for which it is approved. The vaccine is approved for individuals ages 9-45 years old and participants in this study will be 27-45 years of age. The purpose of the study is to examine the immune response of 2 doses of 9vHPV vaccine. The current recommendation is to administer the vaccine in 3 doses (administered at 0, 1-2 months and 6 months) to those 15-45 years of age, but only 2 doses (administered at 0 and 6 months) if the vaccine series is initiated before age 15. The investigators will conduct a randomized study to determine if 2 doses of elicit a similar immune response to that of a standard 3 dose series in individuals 27-45 years of age. Participants in the study group will receive 2 doses of at 0 and 6 months. Participants in the control group will receive 3 doses of 9vHPV vaccine at 0, 2 months, and 6 months. All participants (target accrual n=618) will have 5 mLs of blood drawn at 0, 1, 7, and 12 months. Following the 12-month blood draw, participants randomized to 2-doses will be offered the 3rd dose. Potential participants will be recruited through the University of Texas Medical Branch (UTMB) clinics and surrounding community, and will be screened for inclusion/exclusion criteria. Eligible patients will sign an informed written consent. At their baseline visit, participants will have their blood drawn, be randomized into either the study or control group, and receive their first dose of the HPV vaccine. All participants will receive compensation administered through a ClinCard following each of the 4 blood draws.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunization, HPV Infection, Human Papillomavirus
Keywords
HPV vaccination, Gardasil 9, Noninferiority trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Vials submitted for assay will be de-identified and labeled only with the study ID number.
Allocation
Randomized
Enrollment
618 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Females, 3-dose standard
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Females, 2-dose alternative
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
9-valent HPV vaccine, 2 doses alternate timing
Intervention Description
Evaluate 2 doses of the 9-valent HPV vaccine across a 12-month period following the 1st dose among 27-45-year-old females.
Intervention Type
Biological
Intervention Name(s)
9-valent HPV vaccine, 3 doses standard timing
Intervention Description
This will be the comparison group for the 2-dose group.
Primary Outcome Measure Information:
Title
Short-term human papillomavirus (HPV) type-specific antibody response for type HPV-6
Description
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.
Time Frame
Month 1
Title
Short-term human papillomavirus (HPV) type-specific antibody response for type HPV-6
Description
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.
Time Frame
Month 7
Title
Short-term human papillomavirus (HPV) type-specific antibody response for type HPV-6
Description
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.
Time Frame
Month 12
Title
Short-term HPV type-specific antibody response for type HPV-11
Description
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.
Time Frame
Month 1
Title
Short-term HPV type-specific antibody response for type HPV-11
Description
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.
Time Frame
Month 7
Title
Short-term HPV type-specific antibody response for type HPV-11
Description
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.
Time Frame
Month 12
Title
Short-term HPV type-specific antibody response for type HPV-16
Description
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.
Time Frame
Month 1
Title
Short-term HPV type-specific antibody response for type HPV-16
Description
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.
Time Frame
Month 7
Title
Short-term HPV type-specific antibody response for type HPV-16
Description
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.
Time Frame
Month 12
Title
Short-term HPV type-specific antibody response for type HPV-18
Description
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.
Time Frame
Month 1
Title
Short-term HPV type-specific antibody response for type HPV-18
Description
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.
Time Frame
Month 7
Title
Short-term HPV type-specific antibody response for type HPV-18
Description
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.
Time Frame
Month 12
Title
Short-term HPV type-specific antibody response for type HPV-31
Description
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.
Time Frame
Month 1
Title
Short-term HPV type-specific antibody response for type HPV-31
Description
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.
Time Frame
Month 7
Title
Short-term HPV type-specific antibody response for type HPV-31
Description
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.
Time Frame
Month 12
Title
Short-term HPV type-specific antibody response for type HPV-33
Description
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.
Time Frame
Month 1
Title
Short-term HPV type-specific antibody response for type HPV-33
Description
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.
Time Frame
Month 7
Title
Short-term HPV type-specific antibody response for type HPV-33
Description
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.
Time Frame
Month 12
Title
Short-term HPV type-specific antibody response for type HPV-45
Description
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.
Time Frame
Month 1
Title
Short-term HPV type-specific antibody response for type HPV-45
Description
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.
Time Frame
Month 7
Title
Short-term HPV type-specific antibody response for type HPV-45
Description
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.
Time Frame
Month 12
Title
Short-term HPV type-specific antibody response for type HPV-52
Description
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.
Time Frame
Month 1
Title
Short-term HPV type-specific antibody response for type HPV-52
Description
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.
Time Frame
Month 7
Title
Short-term HPV type-specific antibody response for type HPV-52
Description
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.
Time Frame
Month 12
Title
Short-term HPV type-specific antibody response for type HPV-58
Description
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.
Time Frame
Month 1
Title
Short-term HPV type-specific antibody response for type HPV-58
Description
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.
Time Frame
Month 7
Title
Short-term HPV type-specific antibody response for type HPV-58
Description
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.
Time Frame
Month 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
27 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. Exclusion criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abbey B Berenson, MD, PhD
Phone
409-772-2417
Email
abberens@utmb.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rosalina M Trujillo
Phone
409-747-5594
Email
rmtrujil@utmb.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abbey B Berenson, MD, PhD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosalina M Trujillo
Phone
409-747-5594
Email
rmtrujil@UTMB.EDU

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs