Gardasil 9 Vaccination Regimen for HPV
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What safety data is available for Gardasil 9?
Gardasil 9, a 9-valent HPV vaccine, has been evaluated for safety in multiple studies. A post-licensure study in the USA assessed its safety following routine administration. Nonclinical studies in rats showed no adverse effects, with expected immune responses and local inflammation that resolved over time. A study in Italy reported a low rate of adverse events, with only 2 serious events consistently associated with the vaccine out of 266,647 doses. Overall, Gardasil 9 has a favorable safety profile with a low rate of serious adverse events.12345
Is Gardasil 9 generally safe for humans?
Is Gardasil 9 a promising drug for HPV?
How is the Gardasil 9 treatment different from other HPV treatments?
Gardasil 9 is unique because it protects against nine types of HPV, including five additional high-risk types not covered by earlier vaccines, increasing protection from about 70% to 90% against cervical cancer. It also offers a flexible dosing schedule, with a 2-dose regimen for younger individuals that is as effective as the traditional 3-dose regimen.12367
What data supports the idea that Gardasil 9 Vaccination Regimen for HPV is an effective treatment?
The available research shows that Gardasil 9 is effective in preventing HPV infections. It covers more HPV types than earlier vaccines, increasing protection from about 70% to 90% against cervical cancer-causing strains. Clinical trials demonstrated that the vaccine is safe and effective, with strong immune responses in both young women and younger boys and girls. The 2-dose regimen for younger individuals was found to be as effective as the 3-dose regimen for older individuals, making it a practical and efficient option.12367
What data supports the effectiveness of the Gardasil 9 treatment for HPV?
Research shows that the Gardasil 9 vaccine, which protects against nine types of HPV, can increase protection from about 70% to 90% against cervical cancer-causing HPV types. Clinical trials demonstrated that the 2-dose regimen for younger individuals (ages 9-14) is as effective as the 3-dose regimen for older individuals (ages 16-26).12367
Who Is on the Research Team?
Carl G Streed, MD MPH
Principal Investigator
Boston Medical Center, Internal Medicine
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a 2-dose or 3-dose regimen of Gardasil 9
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension
Participants in the 2-dose group receive a rescue 3rd dose at month 12
What Are the Treatments Tested in This Trial?
Interventions
- Gardasil 9 2 dose regimen
- Gardasil 9 3 dose regimen
- Gardasil 9 rescue dose
Gardasil 9 2 dose regimen is already approved in European Union, United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Medical Center
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University