HPV Infection, Human Papillomavirus, Immunization
Conditions
Keywords
HPV vaccination, Gardasil 9, Noninferiority trial
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.
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.
Interventions
BIOLOGICAL9-valent HPV vaccine, 2 doses alternate timing
Evaluate 2 doses of the 9-valent HPV vaccine across a 12-month period following the 1st dose among 27-45-year-old females.
This will be the comparison group for the 2-dose group.
Sponsors
The University of Texas Medical Branch, Galveston
Cancer Prevention Research Institute of Texas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Vials submitted for assay will be de-identified and labeled only with the study ID number.
Eligibility
Sex/Gender
FEMALE
Age
27 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short-term human papillomavirus (HPV) type-specific antibody response for type HPV-6 | 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. |
| Short-term HPV type-specific antibody response for type HPV-11 | 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. |
| Short-term HPV type-specific antibody response for type HPV-16 | 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. |
| Short-term HPV type-specific antibody response for type HPV-18 | 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. |
| Short-term HPV type-specific antibody response for type HPV-31 | 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. |
| Short-term HPV type-specific antibody response for type HPV-33 | 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. |
| Short-term HPV type-specific antibody response for type HPV-45 | 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. |
| Short-term HPV type-specific antibody response for type HPV-52 | 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. |
| Short-term HPV type-specific antibody response for type HPV-58 | 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. |
Countries
United States
Contacts
CONTACTAbbey B Berenson, MD, PhD
CONTACTRosalina M Trujillo
PRINCIPAL_INVESTIGATORAbbey B Berenson, MD, PhD
University of Texas
Outcome results
None listed