Actively Recruiting
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Led by The University of Texas Medical Branch, Galveston · Updated on 2025-10-06
618
Participants Needed
1
Research Sites
236 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Medical Branch, Galveston
Lead Sponsor
C
Cancer Prevention Research Institute of Texas
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Females 27-45 years old
- Ability to give informed consent
- Has not received any prior doses of the HPV vaccine, verified by state registry and medical records
- Reliable telephone access for the duration of the project
- Can read and speak English or Spanish
- Has identified funding source for the vaccine such as Medicaid, private insurance, or Texas Healthy Women program
- Reports consistent use of reliable birth control and plans to continue through study month 13
You will not qualify if you...
- Currently pregnant, planning pregnancy, or donating eggs in the next 13 months
- Has an immunodeficiency or autoimmune disease like HIV, lymphoma, leukemia, lupus, rheumatoid arthritis, or inflammatory bowel disease
- Currently receiving immune-suppressing treatments or medications including chemotherapy, radiation, certain monoclonal antibodies, or systemic corticosteroids (oral or injection)
- History of splenectomy
- Known allergies to vaccine components such as aluminum, yeast, or Benzonase
- Febrile with temperature ≥100°F in 24 hours before vaccination
- History of thrombocytopenia or bleeding disorders contraindicating intramuscular injections
- History of more than 10 lifetime sexual partners at enrollment
- Plans to move out of the Galveston/Houston area within 13 months after enrollment
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Actively Recruiting
Research Team
A
Abbey B Berenson, MD, PhD
CONTACT
R
Rosalina M Trujillo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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