Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis.
Hanna Bergman, Nicholas Henschke, Ingrid Arevalo-Rodriguez...
https://pubmed.ncbi.nlm.nih.gov/41276263Actively Recruiting
Phase 4
Age: 27Years - 45Years
FEMALE
Healthy Volunteers
ID05672927
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
Led by The University of Texas Medical Branch, Galveston · Updated on 2025-10-06
618
Participants Needed
1
Research Sites
52 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
Researchers are studying whether two doses of the 9-valent HPV vaccine given to women aged 27 to 45 produce a similar immune response compared to the standard three-dose series. The vaccine is already approved for this age group with a three-dose schedule, but younger individuals typically receive two doses. This trial aims to see if two doses can provide an immune response that is not inferior to three doses in this adult female population. Participants will be randomly assigned to one of two groups: one group will receive two doses of the vaccine at 0 and 6 months, while the other group will receive three doses at 0, 2, and 6 months. After 12 months, women who received two doses will be offered a third dose. Blood samples will be collected four times over the course of 12 months to measure immune response. During the study, women will provide blood samples at the start, 1 month, 7 months, and 12 months after the first vaccine dose. They will also be monitored for antibody responses to multiple HPV types. Participants will receive compensation after each blood draw, and reliable telephone access is required for communication throughout the study. The total participation period lasts about 13 months, including the optional third dose offered at the end for the two-dose group.
CONDITIONS
Brief Title
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Who Can Participate
Age: 27Years - 45Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Female and between 27 and 45 years old
- Able to give informed consent
- Has not received any prior HPV vaccine doses, verified by records
- Has reliable telephone access for the study duration
- Can read and speak English or Spanish
- Has identified funding source for the vaccine (e.g., insurance, Medicaid)
- Reports consistent use of reliable birth control and plans to continue through study month 13
You will not qualify if you...
- Currently pregnant or plans to become pregnant or donate eggs in the next 13 months
- Has immunodeficiency or autoimmune diseases such as HIV, lymphoma, leukemia, lupus, rheumatoid arthritis, inflammatory bowel disease, or similar
- Receiving immune-suppressing treatments like chemotherapy, radiation, certain medications including systemic corticosteroids
- History of splenectomy
- Allergic to any vaccine components including aluminum, yeast, or Benzonase
- Fever of 100°F or higher within 24 hours before vaccination
- History of bleeding or clotting disorders that affect intramuscular injections
- History of more than 10 lifetime sexual partners at enrollment
- Plans to move out of the area within 13 months after enrollment
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 months
Participants receive either 2 or 3 doses of the 9-valent HPV vaccine over a 6-month period.
3 vaccination visits at 0, 2 (for 3-dose group only), and 6 months
Monitoring
Duration - 12 months
Participants have blood drawn for immune response evaluation at multiple time points.
4 blood draw visits at 0, 1, 7, and 12 months
Follow-up
Duration - After 12 months
Participants in the 2-dose group are offered a third vaccine dose after their final blood draw at 12 months.
1 optional vaccination visit after 12-month blood draw
Trial Site Locations
Total: 1 location
1
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Actively Recruiting
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Research Team
A
Abbey B Berenson, MD, PhD
R
Rosalina M Trujillo
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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