GARDASIL 9: 3 Dose vs. 2 Dose With Delayed 3rd Dose

Last updated: April 9, 2025
Sponsor: The University of Texas Medical Branch, Galveston
Overall Status: Active - Not Recruiting

Phase

4

Condition

N/A

Treatment

9-valent HPV vaccine, 2 dose efficacy

9-valent HPV vaccine, 3 doses standard timing

Clinical Study ID

NCT03943875
19-0058
RP190022
  • Ages 15-26
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Inclusion

Inclusion Criteria:

  1. Males and females 15-26 years old.

  2. Ability to give informed consent. All participants under 18 years of age must havethe informed consent of a parent and must assent to participation.

  3. Has not received any prior doses of the HPV vaccine. We will ask the patient andhis/her parent (if <18) about prior vaccination and check the state registry (Immtrac), as well as the UTMB electronic medical record (if previously seen atUTMB), We will check with their primary care provider, if feasible, for patients whoare not a previously established UTMB patient.

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

  5. Reliable telephone access.

  6. Participant and parent/ guardian (if <18) can read and speak either English orSpanish.

Exclusion

Exclusion Criteria:

  1. For females, currently pregnant or plans to become pregnant or donate eggs in next 12 months. Sexually active females must report that they use regular birth control.All female subjects will be required to take a urine pregnancy test before eachGardasil 9 dose, unless it can be verified that she gave birth within the last week.Any subjects with positive tests at the initial visit will be disqualified from thestudy and advised to seek prenatal care. If a subject is pregnant when her follow-upvisit window closes, she will be removed from the study.

  2. History of 6 or more lifetime sexual partners.

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

  4. History of bleeding or platelet disorders such as hemophilia.

  5. Currently taking medication which can suppress immune function including systemiccorticosteroids, radiation therapy, cyclophosphamide, azathioprine, methotrexate,cyclosporine, leflunomide, TNF-alpha antagonists, monoclonal antibody therapies, orintravenous immunoglobulin treatment.

  6. Known allergies to any components of the vaccine, including aluminum, yeast orBenzonase.

  7. Febrile at ≥100°F in the 24 hours prior to vaccination. This will be reviewed beforeeach Gardasil 9 dose.

  8. Received any non-study inactive vaccines within the past 14 days or any livevaccines within the past 30 days. Those excluded for this reason will be re-screenedunder the same study number at a later date.

  9. Plan to move out of the Galveston/Houston area in the 13 months following studyentry.

Study Design

Total Participants: 757
Treatment Group(s): 2
Primary Treatment: 9-valent HPV vaccine, 2 dose efficacy
Phase: 4
Study Start date:
June 17, 2019
Estimated Completion Date:
March 01, 2026

Study Description

The investigators are studying an amended dosing regimen of an approved drug (Gardasil 9) in the population for which it is approved (vaccine is approved for ages 9-45 years and participants in this study will be 15-26 years of age.) The purpose of the study is to examine a delayed dosing schedule. The current recommendation is to administer the vaccine in 3 doses (administered at 0, 1-2 months and 6 months) to those 15-26 years of age but only 2 doses (0 and 6 months) if given at 9-14 years of age. The investigators will conduct a randomized study to determine if 2 doses will elicit an immune response similar to the standard 3 doses in those 15-26 years of age. Participants in the study group will receive 2 doses of Gardasil 9 at 0 and 6 months. Participants in the control group will receive 3 doses of Gardasil 9 at 0, 1-2 months and 6 months. All participants (Target Accrual n=512) will have 5 mLs of blood drawn at 0, 7, and 12 months. Following the 12 month blood draw, participants randomized to 2-doses will receive the 3rd dose. Potential participants will be recruited in the University of Texas Medical Branch (UTMB) clinics where providers have given the PI permission to directly contact patients. The investigators will also display signs and use email announcements at UTMB and other college campuses and will advertise the study online or by mail. The investigators will call UTMB patients if their provider gave permission to contact the patient, or if the patients gave prior consent to contact through the UTMB system. Potential participants (and their parents, if under 18 years of age) will be screened with inclusion/exclusion criteria. Eligible and interested parents and patients will sign informed written consent. Patients under 18 years of age will sign written assent. At the initial visit, eligible, consented participants will have their blood drawn, be randomized into either the study or control group, and receive a dose of the HPV vaccine. Participants will be re-screened against the inclusion/exclusion criteria at subsequent visits. All participants will receive compensation administered through a ClinCard following each of the 3 blood draws.

Connect with a study center

  • University of Texas Medical Branch

    Galveston, Texas 77555
    United States

    Site Not Available

  • Jacqueline Hirth

    League City, Texas 77573
    United States

    Site Not Available

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