HPV Vaccine Dosing Schedules for HPV Prevention

Recruiting in Palo Alto (17 mi)

Overseen byAbbey B Berenson, MD, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: The University of Texas Medical Branch, Galveston

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?We are evaluating whether 15-26 year old males and females need a 3rd dose of the human papillomavirus (HPV) vaccine, or whether 2 doses provide similar protection as 3 doses from the 9 types of HPV that it protects against.

Eligibility Criteria

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.

Inclusion Criteria

Reliable telephone access

Identified source of funding for vaccine which may include Texas Vaccines for Children (VFC) program, Medicaid, the Children's Health Insurance Plan (CHIP), Texas Healthy Women program or other public or private health insurance

Participant and parent/ guardian (if <18) can read and speak either English or Spanish

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Exclusion Criteria

I am not pregnant, do not plan to be in the next year, and use birth control.

Plan to move out of the Galveston/Houston area in the 13 months following study entry.

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

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Participant Groups

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.

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.

9-valent HPV vaccine is already approved in United States, European Union, Canada, Switzerland for the following indications:

🇺🇸 Approved in United States as Gardasil 9 for:

Cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58
Cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Genital warts caused by HPV Types 6 and 11

🇪🇺 Approved in European Union as Gardasil 9 for:

Cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58
Cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Genital warts caused by HPV Types 6 and 11

🇨🇦 Approved in Canada as Gardasil 9 for:

Cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58
Cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Genital warts caused by HPV Types 6 and 11

🇨🇭 Approved in Switzerland as Gardasil 9 for:

Cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58
Cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Genital warts caused by HPV Types 6 and 11