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

Running, not enrolling · Phase 4

Conditions studied: HPV Infection

In brief

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.

Key facts

Study ID

NCT04206813

Run by

Boston Medical Center

People needed

352

Starts

2020-12-01

Expected to finish

2026-10-01

Last updated by the study team

2026-04-29

Who can join

Age: 16 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Women receiving care at Boston Medical Center

You may not qualify if…

• 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

Where it is running

• Boston Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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