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

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boston Medical Center
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Vaccines

Criteria

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