352 Participants Needed

Gardasil 9 Vaccination Regimen for HPV

NJ
CY
JS
Overseen ByJohane Seide, MPH
Age: < 65
Sex: Female
Trial Phase: Phase 4
Sponsor: Boston Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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?

Gardasil 9 has been shown to have a favorable safety profile in both clinical trials and real-world studies, with a low rate of serious adverse events. Most reported side effects are mild, such as local reactions at the injection site, and serious adverse events are rare.12345

Is Gardasil 9 a promising drug for HPV?

Yes, Gardasil 9 is a promising drug for HPV. It covers more HPV types than earlier vaccines, increasing protection from about 70% to 90%. It has been shown to be safe and effective in both 2-dose and 3-dose regimens, making it a strong option for preventing HPV-related diseases.12367

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?

CG

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

I am a woman receiving care at Boston Medical Center.

Exclusion Criteria

You've had a severe allergic reaction before, especially to yeast, or you know you're allergic to any part of the vaccine.
I have a blood clotting disorder or low platelet count.
I have received the HPV vaccine.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person or phone)

Treatment

Participants receive either a 2-dose or 3-dose regimen of Gardasil 9

6 months
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
1 visit (in-person)

Extension

Participants in the 2-dose group receive a rescue 3rd dose at month 12

1 month
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Gardasil 9 2 dose regimen
  • Gardasil 9 3 dose regimen
  • Gardasil 9 rescue dose
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention groupExperimental Treatment2 Interventions
Group II: Control groupActive Control1 Intervention

Gardasil 9 2 dose regimen is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Gardasil 9 for:
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Approved in United States as Gardasil 9 for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials
410
Recruited
890,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

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 profile image

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

Published Research Related to This Trial

The nine-valent HPV vaccine, Gardasil9, significantly increases the efficacy against cervical cancer from 70% to 90% compared to the quadrivalent vaccine, covering a broader range of HPV types.
Gardasil9 also provides high efficacy (97%) against lesions associated with HPV types 31, 33, 45, 52, and 58, while maintaining similar effectiveness against HPV types 6, 11, 16, and 18 as the quadrivalent vaccine.
[Nine-valent HPV vaccine - new generation of HPV vaccine].Fait, T., Dvořák, V., Pilka, R.[2018]
A study involving 215,965 individuals who received the nine-valent HPV vaccine (HPV9) found no new safety concerns, confirming its established safety profile from previous research.
While some elevated event categories were noted, such as skin disorders and ill-defined conditions, most were either previously known or had other causes, and no deaths were linked to the vaccine.
Safety of 9-valent human papillomavirus vaccine administered to males and females in routine use.Hansen, J., Yee, A., Lewis, N., et al.[2023]
The 9-valent HPV vaccine (9vHPV) is highly immunogenic in females aged 12-26 who previously received the quadrivalent HPV vaccine (qHPV), with over 98% showing seropositivity for additional HPV types 31/33/45/52/58 after the third dose.
While injection-site adverse events were more common in the 9vHPV group (91.1%) compared to placebo (43.9%), systemic adverse events were similar between both groups, indicating that the 9vHPV vaccine is generally well tolerated.
Safety and immunogenicity of a 9-valent HPV vaccine in females 12-26 years of age who previously received the quadrivalent HPV vaccine.Garland, SM., Cheung, TH., McNeill, S., et al.[2016]

Citations

1.Czech Republicpubmed.ncbi.nlm.nih.gov
[Nine-valent HPV vaccine - new generation of HPV vaccine]. [2018]
Safety of 9-valent human papillomavirus vaccine administered to males and females in routine use. [2023]
Safety and immunogenicity of a 9-valent HPV vaccine in females 12-26 years of age who previously received the quadrivalent HPV vaccine. [2016]
Expanded strain coverage for a highly successful public health tool: Prophylactic 9-valent human papillomavirus vaccine. [2019]
HPV16/18 Antibody Responses After a Single Dose of Nonavalent HPV Vaccine. [2023]
Evaluation of a 9-valent HPV vaccine in Sprague-Dawley rats: Nonclinical studies assessing general, reproductive, and developmental toxicity. [2019]
Real-Life Safety Profile of the 9-Valent HPV Vaccine Based on Data from the Puglia Region of Southern Italy. [2022]
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