NCT05672927 Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
| NCT ID | NCT05672927 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | The University of Texas Medical Branch, Galveston |
| Condition | Immunization |
| Study Type | INTERVENTIONAL |
| Enrollment | 618 participants |
| Start Date | 2023-01-18 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 618 participants in total. It began in 2023-01-18 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion criteria: 1. Females 27-45 years old. 2. Ability to give informed consent. 3. 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. 4. Reliable telephone access for the duration of the project. 5. Can read and speak in either English or Spanish. 6. Identified source of funding for vaccine such as Medicaid, private health insurance, Texas Healthy Women program, etc. 7. Reports consistent use of reliable birth control and plans to continue its use through study month 13. Exclusion criteria: 1. 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. 2. Has an immunodeficiency or autoimmune disease such as HIV infection, lymphoma, leukemia, lupus, rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition. 3. 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. 4. History of splenectomy 5. Known allergies to any vaccine components, including aluminum, yeast or Benzonase. 6. Febrile at ≥100°F in the 24 hours prior to vaccination. The patients may be rescheduled for a later date. 7. History of thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections. 8. History of \>10 sexual partners in their lifetime at time of enrollment 9. Plans to move out of the Galveston/Houston area in the 13 months following study entry.
Contact & Investigator
Abbey B Berenson, MD, PhD
PRINCIPAL INVESTIGATOR
University of Texas
Frequently Asked Questions
Who can join the NCT05672927 clinical trial?
This trial is open to female participants only, aged 27 Years or older, up to 45 Years, studying Immunization. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05672927 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05672927 currently recruiting?
Yes, NCT05672927 is actively recruiting participants. Contact the research team at abberens@utmb.edu for enrollment information.
Where is the NCT05672927 trial being conducted?
This trial is being conducted at Galveston, United States.
Who is sponsoring the NCT05672927 clinical trial?
NCT05672927 is sponsored by The University of Texas Medical Branch, Galveston. The principal investigator is Abbey B Berenson, MD, PhD at University of Texas. The trial plans to enroll 618 participants.