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
The University of Texas Medical Branch, Galveston
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.
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 investiga…
Eligibility
- Age range
- 27–45 years
- Sex
- Female
- 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.…
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.
- Biological9-valent HPV vaccine, 3 doses standard timing
This will be the comparison group for the 2-dose group.
Location
- University of Texas Medical BranchGalveston, Texas