NCT04206813

An Exploratory Open-Label Clinical Trial Evaluating the Immunogenicity of the 9-valent 2-dose HPV Vaccination Regimen

An Open-Label Clinical Trial Evaluating the Immunogenicity of the 9vHPV Vaccination Regimen Over 6 Months Among Women Aged 16 to 45 Years Old, An Exploratory Immunogenicity Study

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 352 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: Female
• Age: 16 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• HPV Infection

Interventions

Type	Name	Description
DRUG	Gardasil 9 2 dose regimen	a 2-dose regimen of Gardasil 9 at 0 and 6 months
DRUG	Gardasil 9 3 dose regimen	standard 3-dose regimen of Gardasil 9 at 0, 2, 6 months
DRUG	Gardasil 9 rescue dose	A rescue dose of Gardasil 9 will be given at 12 months

Timeline

• Start date: 2020-12-01
• Primary completion: 2026-04-01
• Completion: 2026-06-01
• First posted: 2019-12-20
• Last updated: 2026-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study