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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
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 belowSelect...
I am between 15 and 26 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of immune system issues, like HIV, autoimmune disorders, or have had my spleen removed.
Select...
I have a history of bleeding or disorders like hemophilia.
Select...
I have had 6 or more sexual partners in my lifetime.
Select...
I am currently on medication that affects my immune system.
Select...
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
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 moreTrial 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
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 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.
Find a Location
Who is running the clinical trial?
Cancer Prevention Research Institute of TexasOTHER
52 Previous Clinical Trials
98,203 Total Patients Enrolled
The University of Texas Medical Branch, GalvestonLead Sponsor
249 Previous Clinical Trials
55,883 Total Patients Enrolled
Abbey B Berenson, MD, PhDPrincipal InvestigatorUniversity of Texas
1 Previous Clinical Trials
618 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, do not plan to be in the next year, and use birth control.I have a history of immune system issues, like HIV, autoimmune disorders, or have had my spleen removed.I have a history of bleeding or disorders like hemophilia.I haven't had non-live vaccines in the last 14 days or live vaccines in the last 30 days.I have had 6 or more sexual partners in my lifetime.I am between 15 and 26 years old.I am currently on medication that affects my immune system.I have not had a fever of 100°F or higher in the last 24 hours.I have never received the HPV vaccine.I can make my own medical decisions, or if under 18, my parent agrees.
Research Study Groups:
This trial has the following groups:- Group 1: Females, 2 dose with delayed 3rd dose
- Group 2: Females, 3 dose standard
- Group 3: Males, 3 dose standard
- Group 4: Males, 2 dose with delayed 3rd dose
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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