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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
Must not have
Thrombocytopenia or other coagulation disorder
Prior HPV vaccination
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 7
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
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.
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.
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.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a blood clotting disorder or low platelet count.
Select...
I have received the HPV vaccine.
Select...
I have a weakened immune system or have been on immunosuppressive therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 7
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 7
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in geometric mean titers ratios
Change in immunogenicity of Gardasil 9
Secondary study objectives
Number of participants with HPV seropositivity at day 1
Number of participants with HPV seropositivity at month 7
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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)
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
4,032 Previous Clinical Trials
5,189,440 Total Patients Enrolled
Boston Medical CenterLead Sponsor
405 Previous Clinical Trials
884,601 Total Patients Enrolled
Natalie Joseph, MD MPHPrincipal InvestigatorBoston Medical Center
2 Previous Clinical Trials
180 Total Patients Enrolled