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Cancer Vaccine
Gardasil 9 Vaccination Regimen for HPV
Phase 4
Recruiting
Led By Natalie Joseph, MD MPH
Research Sponsored by Boston Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 7
Awards & highlights
Study Summary
This trial is testing a 2-dose schedule of the HPV vaccine Gardasil 9 in women aged 16-45, to see if it is safe and produces an immune response.
Who is the study for?
This trial is for women aged 16-45 who are patients at Boston Medical Center and have not been vaccinated against HPV. They must not be pregnant, breastfeeding, have blood clotting disorders, severe allergies (especially to yeast), or a compromised immune system.Check my eligibility
What is being tested?
The study tests if two doses of Gardasil 9 provide the same immune response in women aged 16-45 as three doses do in those aged 16-26. It also explores the safety of this reduced-dose regimen compared to the standard three-dose schedule.See study design
What are the potential side effects?
Possible side effects include pain at injection site, headache, fever, nausea, dizziness. Rarely there may be allergic reactions which could be serious.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 7
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 7
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in geometric mean titers ratios
Change in immunogenicity of Gardasil 9
Secondary outcome measures
Number of participants with HPV seropositivity at day 1
Number of participants with HPV seropositivity at month 7
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention groupExperimental Treatment2 Interventions
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)
Group II: Control groupActive Control1 Intervention
120 eligible women will receive the standard 3-dose regimen of Gardasil 9 at (0, 2, 6 months)
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Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,896 Previous Clinical Trials
5,061,999 Total Patients Enrolled
Boston Medical CenterLead Sponsor
385 Previous Clinical Trials
873,210 Total Patients Enrolled
Natalie Joseph, MD MPHPrincipal InvestigatorBoston Medical Center
1 Previous Clinical Trials
100 Total Patients Enrolled
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