Gardasil-9 for HPV Prevention

(CIRN-HPV-ONE Trial)

Overseen By Jo-Ann Costa

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Canadian Immunization Research Network

Disqualifiers: Immunosuppressed

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how well a single dose of the HPV vaccine (Gardasil-9) protects against the virus over six years, with a particular focus on its effectiveness for boys compared to girls. The study is open to youth who received only one dose of the vaccine in Grade 4 during the 2019-2020 school year. Participants must answer a few health questions and provide a small blood sample. This research will help determine if one dose provides long-term protection against HPV. As a Phase 4 trial, it involves an FDA-approved vaccine, ensuring safety and effectiveness, and seeks to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are immunosuppressed (have a weakened immune system), you cannot participate in the study.

What is the safety track record for the HPV nonavalent vaccine (Gardasil-9)?

Research has shown that Gardasil-9, the HPV vaccine, is generally well-tolerated. Clinical trials involving over 15,000 females have proven it safe and effective. Common side effects are usually minor, such as pain, swelling, or redness at the injection site. More serious side effects are rare and generally not unexpected.

Gardasil-9 is approved for use in girls and women aged 9 to 45, offering reassurance about its safety across a wide age range. Importantly, ongoing studies have not identified any new safety concerns with the vaccine. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Gardasil-9 is unique because it targets nine different types of HPV, offering broader protection compared to earlier vaccines that covered fewer strains. Researchers are excited about its potential to significantly reduce HPV infections, which are linked to various cancers, including cervical cancer. Unlike previous vaccines, Gardasil-9 might provide long-lasting immunity with just one dose, which could make vaccination programs more efficient and increase accessibility for people worldwide.

What is the effectiveness track record for the Gardasil-9 vaccine in preventing HPV?

Research has shown that the Gardasil-9 vaccine effectively prevents HPV infections. Over 98% of individuals who complete the full series of shots develop protection against the virus. In this trial, researchers will evaluate participants who received one dose of the vaccine six years before recruitment. A study in Kenya found that even a single dose was 97.5% effective in preventing cancer-causing HPV types. Long-term studies have demonstrated that the vaccine remains effective and safe for up to ten years. This suggests that one dose could offer strong protection, although less data is available specifically for boys. ^{6 7 8 9 10}

Who Is on the Research Team?

Chantal Sauvageau, MD

Principal Investigator

INSPQ and Laval University

Are You a Good Fit for This Trial?

This trial is for boys and girls in Quebec who got one dose of the 9vHPV vaccine when they were 9-11 years old during the school year 2019-2020. They must not have had any other HPV vaccines and be able to agree to join the study.

Inclusion Criteria

I can understand and agree to participate in the study.

I received one dose of the 9vHPV vaccine when I was 9-11 years old during 2019-2020.

I have not received any HPV vaccine doses.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Recruitment and Blood Sample Collection

Participants are recruited and a blood sample is collected to assess antibody levels

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after blood sample collection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HPV nonavalent vaccine (Gardasil-9)

Trial Overview The study tests how long HPV antibodies last six years after a single dose of Gardasil-9 given in Grade 4. It involves about 300 students, split evenly between genders, at CHU de Québec-Université Laval research center.

How Is the Trial Designed?

Group I: One HPV vaccine dose received 6 years before recruitment Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Canadian Immunization Research Network

Lead Sponsor

Trials

12

Recruited

10,600+

Citations

1. cdc.gov cdc.gov/vaccines/vpd/hpv/hcp/vaccines.html

HPV Vaccine Efficacy More than 98% of recipients develop an antibody response to HPV types included in the respective vaccines 1 month after completing a full vaccination series.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8706722/

Human Papillomavirus Vaccine Efficacy and Effectiveness ... HPV vaccination has been shown to be highly effective against oral HPV type 16/18 infection, with a significant percentage of participants developing IgG ...

3. publichealth.jhu.edu publichealth.jhu.edu/ivac/the-power-of-a-single-dose-evidence-for-a-single-dose-hpv-vaccine-schedule

Evidence for a Single-Dose HPV Vaccine Schedule In a randomized trial in Kenya (KEN SHE), a single-dose of HPV vaccine was found to be 97.5% effective in preventing cancer-causing strains of HPV among 15–20- ...

4. bmcmedicine.biomedcentral.com bmcmedicine.biomedcentral.com/articles/10.1186/s12916-025-04170-3

Projected health and economic effects of nonavalent versus ... Compared with bivalent vaccination, nonavalent vaccination prevents an additional 1320 high-grade cervical lesions, 70 cancers, 34,000 ...

5. publications.aap.org publications.aap.org/pediatrics/article/152/4/e2022060993/193886/Ten-Year-Follow-up-of-9-Valent-Human

Ten-Year Follow-up of 9-Valent Human Papillomavirus ... Immunogenicity, effectiveness, and safety were demonstrated through 10 years postvaccination. Rates of persistent infection and disease related ...

6. cdc.gov cdc.gov/hpv/hcp/vaccination-considerations/safety-and-effectiveness-data.html

HPV Vaccine Safety and Effectiveness Data Each vaccine was found to be safe and effective in clinical trials. Gardasil 9 was studied in clinical trials with more than 15,000 females and ...

7. gardasil9.com gardasil9.com/patient-pd/what-is-gardasil-9/safety-and-side-effects/

GARDASIL 9 safety and side effects The most common side effects of GARDASIL 9 include: pain, swelling, redness, itching, bruising, bleeding, and a lump where your child got the shot.

8. fda.gov fda.gov/vaccines-blood-biologics/vaccines/gardasil-9

Gardasil 9 GARDASIL 9 is a recombinant vaccine indicated in girls and women 9 through 45 years of age for the prevention of the following diseases:.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8496244/

Update on Safety and Efficacy of HPV Vaccines 4% of the participants reported at least one serious adverse effect, half of which were from the group receiving two doses of the bivalent vaccine while the ...

10. cdc.gov cdc.gov/vaccine-safety/vaccines/hpv.html

Human Papillomavirus (HPV) Vaccine Safety Gardasil 9 protects against 9 types of cancer-causing HPV types 6, 11, 16 ... data, and did not identify any unexpected safety problems with Gardasil 9.