201 Participants Needed

HPV Vaccine for HPV Prevention

Recruiting at 1 trial location
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

Trial Summary

What is the purpose of this trial?

Human papillomavirus (HPV) is a common sexually-transmitted virus which causes infections that usually last only a few months, but sometimes can last a long time and cause cancers of the cervix, vagina, vulva, anus or oropharynx over many years among adults. This phase IIA trial studies how well does the nonavalent HPV vaccine (which can prevent nine different types of HPV) work when given in an alternative dosing schedule to heathy young research participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on immunosuppressive drugs, chemotherapy, or certain other treatments. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the HPV vaccine treatment for HPV prevention?

Research shows that HPV vaccines, including the nonavalent vaccine, have been effective in reducing HPV infections and related diseases, such as cervical cancer and genital warts, by generating strong immune responses that neutralize the virus.12345

Is the HPV vaccine safe for humans?

The HPV vaccines, including the nonavalent version, have been studied extensively for safety. Most studies show they are generally safe, but some trials reported more severe adverse events in the vaccine group compared to control groups. However, these events were not judged to be directly related to the vaccine.678910

How is the nonavalent HPV vaccine different from other HPV vaccines?

The nonavalent HPV vaccine is unique because it protects against nine HPV types, including seven high-risk types that can lead to cancer and two low-risk types that cause genital warts, offering broader protection compared to the bivalent and quadrivalent vaccines.311121314

Research Team

H(

Hsiao-Hui (Sherry) Chow

Principal Investigator

The University of Arizona Medical Center-University Campus

Eligibility Criteria

This trial is for healthy, medically well boys and girls who can understand and agree to participate. They must not have had an HPV vaccine before, be on immunosuppressive drugs, or have significant health issues like heart or kidney problems. Pregnant individuals or those with a history of allergic reactions to similar vaccines are excluded.

Inclusion Criteria

I am a healthy child with no medical issues.
Ability to understand and the willingness to sign a written assent document by the participant
I (or my legal representative) can understand and am willing to sign the consent form.

Exclusion Criteria

You have a condition that weakens your immune system or makes it less effective.
I haven't taken immune-weakening drugs in the last 6 months, except for inhaled steroids, nasal sprays, or topical creams.
I do not have severe lung, heart, liver, or kidney problems that would stop me from getting the study vaccine.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Priming Injection

Participants receive the recombinant human papillomavirus nonavalent vaccine intramuscularly at baseline

Baseline
1 visit (in-person)

Booster Injection

Participants receive booster injections of the vaccine at 24 and 30 months

6 months
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks
1 visit (in-person)

Treatment Details

Interventions

  • Recombinant Human Papillomavirus Nonavalent Vaccine
Trial Overview The study is testing the effectiveness of the nonavalent HPV vaccine given in a different dosing schedule to prevent nine types of HPV in young participants. It also involves laboratory analysis to monitor biomarkers related to the vaccine's effect.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Prevention (Gardasil 9)Experimental Treatment2 Interventions
Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline (priming injection) and at 24 and 30 months (booster injections).

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Findings from Research

While clinical trials have shown that HPV vaccines are highly effective, their effectiveness in the general population is still not fully understood, highlighting the need for further research.
A comprehensive review of HPV-related clinical outcomes suggests that tracking these outcomes at the population level is crucial for evaluating the real-world effectiveness of HPV vaccines, as many large trials are nearing completion.
Evaluating the impact of human papillomavirus vaccines.Chang, Y., Brewer, NT., Rinas, AC., et al.[2009]
HPV-related cancers, including cervical and head and neck cancers, account for a significant portion of global cancer cases, highlighting the urgent need for effective vaccination strategies, especially since over 80% of people are exposed to HPV by age 50.
While prophylactic vaccines like Gardasil® and Cervarix® have successfully reduced HPV infections in young populations, there are currently no FDA-approved therapeutic vaccines for those already infected, indicating a critical gap in treatment options for HPV-related diseases.
Therapeutic Vaccines for HPV-Associated Malignancies.Smalley Rumfield, C., Roller, N., Pellom, ST., et al.[2020]
There are three licensed HPV vaccines: bivalent, quadrivalent, and nonavalent, with the nonavalent vaccine introduced in 2014, yet vaccination coverage remains low in many developed countries due to safety concerns.
This review aims to clarify the safety profiles of all three HPV vaccines by summarizing data from both pre- and post-licensure studies, particularly focusing on the newer nonavalent vaccine.
Safety of HPV vaccines in the age of nonavalent vaccination.Quattrone, F., Canale, A., Filippetti, E., et al.[2018]

References

Prophylactic HPV vaccines: reducing the burden of HPV-related diseases. [2007]
A retrospective study on two cohorts of immunocompetent women treated with nonavalent HPV vaccine vs. Ellagic acid complex: outcome of the evolution of persistent cervical HPV infection. [2022]
HPV Vaccine: Updates and Highlights. [2019]
Evaluating the impact of human papillomavirus vaccines. [2009]
Therapeutic Vaccines for HPV-Associated Malignancies. [2020]
Safety of HPV vaccines in the age of nonavalent vaccination. [2018]
Postlicensure safety evaluation of human papilloma virus vaccines. [2015]
The comparative safety of human papillomavirus vaccines: A Bayesian network meta-analysis. [2022]
Vaccines for the prevention of human papillomavirus infections. [2015]
Serious adverse events after HPV vaccination: a critical review of randomized trials and post-marketing case series. [2022]
Primary prevention of cervical cancer: prophylactic human papillomavirus vaccines. [2012]
12.United Statespubmed.ncbi.nlm.nih.gov
Prevalence and Incidence of Anal and Cervical High-Risk Human Papillomavirus (HPV) Types Covered by Current HPV Vaccines Among HIV-Infected Women in the SUN Study. [2019]
13.United Statespubmed.ncbi.nlm.nih.gov
Estimation of the individual residual risk of cervical cancer after vaccination with the nonavalent HPV vaccine. [2019]
14.United Statespubmed.ncbi.nlm.nih.gov
Population-level impact of the bivalent, quadrivalent, and nonavalent human papillomavirus vaccines: a model-based analysis. [2022]
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