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

Boston Medical Center (BMC)

Status and phase: Active, not recruiting; Phase 4

Conditions: HPV Infection

Treatments: Drug: Gardasil 9 3 dose regimen; Drug: Gardasil 9 rescue dose; Drug: Gardasil 9 2 dose regimen

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04206813

H-39051

Details and patient eligibility

About

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.

Full 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.

Enrollment: 352 patients

Sex: Female

Ages: 16 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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352 participants in 2 patient groups

Intervention group

Experimental group

Description:

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)

Treatment:

Drug: Gardasil 9 2 dose regimen

Drug: Gardasil 9 rescue dose

Control group

Active Comparator group

Description:

120 eligible women will receive the standard 3-dose regimen of Gardasil 9 at (0, 2, 6 months)

Treatment:

Drug: Gardasil 9 3 dose regimen