Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
- Conditions
- HPV InfectionImmunizationHuman Papillomavirus
- Interventions
- Biological: 9-valent HPV vaccine, 2 doses alternate timingBiological: 9-valent HPV vaccine, 3 doses standard timing
- Registration Number
- NCT05672927
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 618
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Females, 2-dose alternative 9-valent HPV vaccine, 2 doses alternate timing Two doses of the 9-valent HPV vaccine to be administered to the experimental group (27-45 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months. Females, 3-dose standard 9-valent HPV vaccine, 3 doses standard timing Three doses of the 9-valent HPV vaccine to be administered to the comparison group (27-45 years of age) at 0, 2, and 6 months.
- Primary Outcome Measures
Name Time Method Short-term HPV type-specific antibody response for type HPV-11 Month 12 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 human papillomavirus (HPV) type-specific antibody response for type HPV-6 Month 12 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-45 Month 12 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-31 Month 12 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-52 Month 12 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 12 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.
Short-term HPV type-specific antibody response for type HPV-33 Month 12 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-16 Month 12 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 12 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States