An Exploratory Open-Label Clinical Trial Evaluating the Immunogenicity of the 9-valent 2-dose HPV Vaccination Regimen
Purpose
The goal of this study is to explore and evaluate whether a 2-dose schedule of Gardasil 9 among young and mid-adult women 16-45 years of age is generally safe and immunogenic, with an antibody response that is not inferior to that observed of a 3-dose schedule of Gardasil 9 among women aged 16-26 years old. The investigators thought that having a 2-dose vaccination regimen for individuals 16 to 45 would provide a more robust dataset than those of 27 to 45 years old.
Condition
- HPV Infection
Eligibility
- Eligible Ages
- Between 16 Years and 45 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Women receiving care at Boston Medical Center
Exclusion Criteria
- Currently pregnant - Prior HPV vaccination - A history of severe allergic reaction, including known allergy to any vaccine component, specially severe allergic to yeast - Immunocompromised/previous immunosuppressive therapy - Thrombocytopenia or other coagulation disorder - Currently breastfeeding
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- The control group will have 120 subjects will receive a 3-dose regimen as recommended by Center for Disease Control (CDC) given at 0, 2 and 6 months. The intervention group will have 240 subjects who will receive a modified 3-dose regimen given at 0, 6, and 12 months. Both groups will have HPV titers drawn at Visit 1 (pre-vaccination) and Visit 7 (after three doses for the Control group and 2 doses for the Intervention group).
- Primary Purpose
- Basic Science
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Intervention group |
240 eligible women will receive a 2-dose regimen of Gardasil 9 at (0 and 6 months, followed by a rescue 3rd dose at month 12) |
|
|
Active Comparator Control group |
120 eligible women will receive the standard 3-dose regimen of Gardasil 9 at (0, 2, 6 months) |
|
Recruiting Locations
Boston, Massachusetts 02118
More Details
- Status
- Recruiting
- Sponsor
- Boston Medical Center
Detailed Description
The investigators will identify potential eligible subjects from the Boston Medical Center (BMC) Clinical Data Warehouse from the following BMC clinics: Pediatrics, Adolescent Medicine, Family Medicine, Obstetric/ Gynecology (OB/GYN), and Women's Health/Adult Primary Care. The research team will mail a recruitment opt-out letter signed by the principal investigator to the participant along with a study flyer. The recruitment letter will inform the participant that a research member may contact them via phone within two week to provide more information regarding the study. Participants opting-in will be called and interviewed with the study recruitment script and eligibility will be determined. Eligible participants who agree to participate (in-person or over the phone), will be scheduled to come to the Boston University (BU) General Clinical Research Unit (GCRU) to complete the consent process. At the baseline visit participants will be assigned into the appropriate group (control vs. intervention) based on their age.