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Virus Vaccine

HPV Vaccine Dosing Schedules for HPV Prevention

Phase 4

Waitlist Available

Led By Abbey B Berenson, MD, PhD

Research Sponsored by The University of Texas Medical Branch, Galveston

Eligibility Criteria Checklist

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

Must have

Males and females 15-26 years old

Be younger than 65 years old

Must not have

History of any immunodeficiencies (HIV+, chemotherapy treatment, status splenectomy) or autoimmune disorders (lupus, thyroid disorder, psoriasis)

History of bleeding or platelet disorders such as hemophilia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 12

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is to see if a third dose of the HPV vaccine is necessary for people aged 15-26, or if two doses provide enough protection against the nine types of HPV it vaccinates against.

Who is the study for?

This trial is for males and females aged 15-26 who haven't had any HPV vaccine doses. They must be able to consent (with parent's consent if under 18), have a way to pay for the vaccine, speak English or Spanish, and have reliable phone access. It's not for those with many sexual partners, immune/autoimmune disorders, bleeding disorders, pregnant women or those planning pregnancy/birth control non-users.

What is being tested?

The study is testing whether two doses of the Gardasil 9 HPV vaccine are as effective as three in preventing infection from nine types of HPV in young people. Participants will either receive the standard three-dose schedule or a two-dose schedule with a delayed third dose.

What are the potential side effects?

Possible side effects of the Gardasil 9 vaccine include pain at injection site, swelling, redness, headaches, fever, nausea and dizziness. Rarely there might be allergic reactions due to components like aluminum or yeast.

Eligibility Criteria

Inclusion Criteria

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

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I am between 15 and 26 years old.

Exclusion Criteria

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

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I have a history of immune system issues, like HIV, autoimmune disorders, or have had my spleen removed.

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I have a history of bleeding or disorders like hemophilia.

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I have had 6 or more sexual partners in my lifetime.

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I am currently on medication that affects my immune system.

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I have not had a fever of 100°F or higher in the last 24 hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 12 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

HPV type-specific antibody response for type HPV-11

HPV type-specific antibody response for type HPV-16

HPV type-specific antibody response for type HPV-18

+15 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Males, 2 dose with delayed 3rd doseExperimental Treatment1 Intervention

Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.

Group II: Females, 2 dose with delayed 3rd doseExperimental Treatment1 Intervention

Group III: Females, 3 dose standardActive Control1 Intervention

Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.

Group IV: Males, 3 dose standardActive Control1 Intervention

Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.

0 / 6Eligibility criteria met