What is the mechanism of action of this treatment?

The most common treatment for Human Papillomavirus (HPV) is vaccination, particularly with the 9-valent HPV vaccine. This vaccine works by stimulating the immune system to produce antibodies against nine different types of HPV, including those most commonly associated with cervical cancer and genital warts. By generating a robust immune response, the vaccine helps prevent initial infection and subsequent development of HPV-related diseases. This is crucial for patients as it significantly reduces the risk of developing cervical cancer, genital warts, and other HPV-associated conditions, thereby improving long-term health outcomes.

What side effects are associated with this type of intervention?

The 9-valent HPV vaccine, which targets nine HPV types, is generally well-tolerated. Common side effects include injection-site reactions such as pain, redness, and swelling. Systemic symptoms like headache, fever, and muscle aches are also reported but are less frequent. These side effects are similar to those observed with other HPV vaccines, such as the bivalent and quadrivalent vaccines. Serious adverse effects are rare, and the vaccine is considered safe for use in the indicated age groups.

What prior FDA approvals exist?

The FDA has approved several vaccines for the prevention of Human Papillomavirus (HPV) infections. The quadrivalent HPV vaccine (Gardasil) protects against four HPV types (6, 11, 16, and 18) and was approved in 2006. The bivalent HPV vaccine (Cervarix), which targets HPV types 16 and 18, was approved in 2009. More recently, the 9-valent HPV vaccine (Gardasil 9) was approved in 2014, expanding protection to nine HPV types (6, 11, 16, 18, 31, 33, 45, 52, and 58). These vaccines work by stimulating the immune system to produce antibodies against these HPV types, thereby preventing infection and associated diseases such as cervical cancer and genital warts.

What other types of research exist?

Promising novel alternatives to the 9-valent HPV vaccine for HPV patients include: 1) 5-aminolevulinic acid-based photodynamic therapy, which has shown effectiveness in treating condylomata acuminata. 2) Intralesional injection of Mycobacterium w vaccine, which has been compared favorably to imiquimod cream in clinical trials. 3) Low-dose oral cyclophosphamide therapy, which has demonstrated efficacy in treating genital warts caused by HPV. These alternatives have shown potential in clinical studies and may offer additional options for HPV treatment in 2024.

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Cancer Vaccine

Gardasil9 Vaccine for Human Papillomavirus

Phase < 1

Waitlist Available

Led By Natalie Pierre-Joseph, MD

Research Sponsored by Boston Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Children aged 4-8 years old

Naïve to HPV Vaccine

Must not have

Immunocompromised/previous immunosuppressive therapy

Thrombocytopenia or other coagulation disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if two shots of an HPV vaccine can help boys and girls aged 4-8 years build strong defenses against nine types of HPV. The goal is to see if young children can develop a good immune response similar to older kids.

Who is the study for?

This trial is for children aged 4-8 who get care at Boston Medical Center or its community health centers and have never had an HPV vaccine. It's not for kids with blood clotting issues, severe allergies (especially to yeast), or weakened immune systems.

What is being tested?

The study tests the effectiveness of a two-dose regimen of Gardasil9, an HPV vaccine, given over one year to prevent warts and human papillomavirus in young children.

What are the potential side effects?

Gardasil9 may cause pain at the injection site, fever, headache, nausea, dizziness. Rarely it can trigger allergic reactions. Side effects are usually mild.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My child is between 4 and 8 years old.

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I have never received the HPV vaccine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a weakened immune system or have been on drugs that lower my immunity.

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I have a blood clotting disorder or low platelet count.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

HPV11 antibodies at 13 months

HPV11 antibodies at 60 months

HPV16 antibodies at 13 months

+15 more

Secondary study objectives

Injection site redness after first injection

Injection site redness after second injection

Injection site swelling after first injection

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

HPV 9-valent human papillomavirus vaccine (Gardasil 9) - 0.5mL intramuscular dose - 2 doses (Month 0, 12)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gardasil9

2019

Completed Phase 4

~420

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatment for Human Papillomavirus (HPV) is vaccination, particularly with the 9-valent HPV vaccine. This vaccine works by stimulating the immune system to produce antibodies against nine different types of HPV, including those most commonly associated with cervical cancer and genital warts. By generating a robust immune response, the vaccine helps prevent initial infection and subsequent development of HPV-related diseases. This is crucial for patients as it significantly reduces the risk of developing cervical cancer, genital warts, and other HPV-associated conditions, thereby improving long-term health outcomes.

Extending Human Papillomavirus (HPV) vaccination beyond female adolescents and after treatment for high grade CIN: the Italian HPV Study Group (IHSG) review and position paper.Current status of human papillomavirus vaccination.