An Exploratory Open-Label Clinical Trial Evaluating the Immunogenicity of the 9-valent 2-dose HPV Vaccination Regimen
- Conditions
- HPV Infection
- Interventions
- Registration Number
- NCT04206813
- Lead Sponsor
- Boston Medical Center
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 352
- Women receiving care at Boston Medical Center
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Gardasil 9 rescue dose 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) Control group Gardasil 9 3 dose regimen 120 eligible women will receive the standard 3-dose regimen of Gardasil 9 at (0, 2, 6 months) Intervention group Gardasil 9 2 dose regimen 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)
- Primary Outcome Measures
Name Time Method Change in geometric mean titers ratios baseline and 7 months The geometric mean titers (GMT) ratios will be determined by a post-vaccination geometric mean titer (GMT) ratio with a pre-stated analysis of variance model (95% Confidence Interval lower bound \>0.5).
Change in immunogenicity of Gardasil 9 baseline and 7 months Immunogenicity will be measured by serum antibodies assessed by ELISA to the nine HPV types (anti-HPV 6/11/16/18/31/33/45/ 52/58 where positive anti-HPV serum levels are defined as \>30, \>16, \>20, \>24, \>10, \>8, \>8, \>8, or \>8 milli Merck units (mMU)/mL respectively).
- Secondary Outcome Measures
Name Time Method Number of participants with HPV seropositivity at day 1 day 1 The number of participant who test positive in mili Unit (nMU) which will be will be defined as anti-HPV 6/11/16/18/31/33/45/ 52/58 positive if her anti-HPV serum level is \>30, \>16, \>20, \>24, \>10, \>8, \>8, \>8, or \>8 milli Merck units (mMU)/mL for the 9 types, respectively. The serum testing will be under the direction of Merck research lab.
Number of participants with HPV seropositivity at month 7 month 7 The number of participant who test positive in mili Unit (nMU) which will be will be defined as anti-HPV 6/11/16/18/31/33/45/ 52/58 positive if her anti-HPV serum level is \>30, \>16, \>20, \>24, \>10, \>8, \>8, \>8, or \>8 milli Merck units (mMU)/mL for the 9 types, respectively. The serum testing will be under the direction of Merck research lab.
Trial Locations
- Locations (1)
Boston Medical Center
🇺🇸Boston, Massachusetts, United States