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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 12
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
50 Previous Clinical Trials
97,681 Total Patients Enrolled
The University of Texas Medical Branch, GalvestonLead Sponsor
241 Previous Clinical Trials
55,841 Total Patients Enrolled
Abbey B Berenson, MD, PhDPrincipal InvestigatorUniversity of Texas
1 Previous Clinical Trials
618 Total Patients Enrolled
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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, 2 dose with delayed 3rd dose
- Group 4: Males, 3 dose standard
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently receiving treatments as part of this experiment?
"Affirmative. Research hosted on clinicaltrials.gov reveals that this medical research project, which was first published on June 17th 2019, is actively recruiting patients at present. The trial necessitates the enrollment of 700 participants from 1 location."
Answered by AI
What are the eligibility requirements for this research trial?
"This clinical trial is enrolling 700 participants aged between 15-26 that have yet to receive any immunizations. Furthermore, applicants must possess reliable telephone access and an identified source of funding for the vaccine such as Texas Vaccines for Children (VFC) program, Medicaid, the Children's Health Insurance Plan (CHIP), Texas Healthy Women programme or other public or private health insurance. To verify prior vaccination history we will consult with patients' primary care provider in addition to Immtrac and UTMB electronic medical record if they had been seen at UTMB before."
Answered by AI
Does the trial permit individuals of younger ages to participate?
"This clinical trial seeks participants aged between 15 and 26 years old."
Answered by AI
Is there still room for participants in this clinical experiment?
"Per the information presented on clinicaltrials.gov, this trial is currently seeking participants. The study had its inception on June 17th 2019 and has been recently amended as of October 5th 2022."
Answered by AI
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