Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age27-45
SponsorThe University of Texas Medical Branch, Galveston
About this trial
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
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- 9-valent HPV vaccine, 2 doses alternate timing
- 9-valent HPV vaccine, 3 doses standard timing
Treatment groups
618 Participants
are divided into 2 treatment groupsSponsors and collaborators
The University of Texas Medical Branch, Galveston
Lead sponsor
Cancer Prevention Research Institute of Texas
Collaborator
Source ClinicalTrials.gov