Active — Not RecruitingPhase 4

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

United States352 participantsStarted 2020-12-01

Plain-language 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.

Who can participate

Age range16 Years – 45 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in immunogenicity of Gardasil 9

Timeframe: baseline and 7 months

Change in geometric mean titers ratios

Timeframe: baseline and 7 months

Trial details

NCT IDNCT04206813

SponsorBoston Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-15

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