- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05672927
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
April 3, 2024 updated by: The University of Texas Medical Branch, Galveston
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
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.
Study Overview
Status
Recruiting
Conditions
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.
Study Type
Interventional
Enrollment (Estimated)
618
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Abbey B Berenson, MD, PhD
- Phone Number: 409-772-2417
- Email: abberens@utmb.edu
Study Contact Backup
- Name: Rosalina M Trujillo
- Phone Number: 409-747-5594
- Email: rmtrujil@UTMB.EDU
Study Locations
-
-
Texas
-
Galveston, Texas, United States, 77555
- Recruiting
- University of Texas Medical Branch
-
Contact:
- Rosalina M Trujillo
- Phone Number: 409-747-5594
- Email: rmtrujil@UTMB.EDU
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
27 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
This will be the comparison group for the 2-dose group.
|
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.
|
Evaluate 2 doses of the 9-valent HPV vaccine across a 12-month period following the 1st dose among 27-45-year-old females.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short-term human papillomavirus (HPV) type-specific antibody response for type HPV-6
Time Frame: Month 1
|
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
Time Frame: Month 7
|
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
Time Frame: Month 12
|
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
Time Frame: Month 1
|
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
Time Frame: Month 7
|
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
Time Frame: Month 12
|
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
Time Frame: Month 1
|
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
Time Frame: Month 7
|
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
Time Frame: Month 12
|
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
Time Frame: Month 1
|
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
Time Frame: Month 7
|
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
Time Frame: Month 12
|
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
Time Frame: Month 1
|
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
Time Frame: Month 7
|
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
Time Frame: Month 12
|
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
Time Frame: Month 1
|
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
Time Frame: Month 7
|
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
Time Frame: Month 12
|
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
Time Frame: Month 1
|
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
Time Frame: Month 7
|
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
Time Frame: Month 12
|
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
Time Frame: Month 1
|
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
Time Frame: Month 7
|
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
Time Frame: Month 12
|
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
Time Frame: Month 1
|
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
Time Frame: Month 7
|
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
Time Frame: Month 12
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Abbey B Berenson, MD, PhD, University of Texas
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 18, 2023
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2027
Study Registration Dates
First Submitted
December 19, 2022
First Submitted That Met QC Criteria
December 21, 2022
First Posted (Actual)
January 5, 2023
Study Record Updates
Last Update Posted (Actual)
April 4, 2024
Last Update Submitted That Met QC Criteria
April 3, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Virus Diseases
- Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Disease Attributes
- DNA Virus Infections
- Tumor Virus Infections
- Urogenital Diseases
- Genital Diseases
- Papillomavirus Infections
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- 22-0243
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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