GARDASIL 9: 3 Dose vs. 2 Dose With Delayed 3rd Dose (NCT03943875) | Clinical Trial Compass
CompletedPhase 4
GARDASIL 9: 3 Dose vs. 2 Dose With Delayed 3rd Dose
United States767 participantsStarted 2019-06-17
Plain-language summary
The investigators 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.
Who can participate
Age range15 Years – 26 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Males and females 15-26 years old.
✓. Ability to give informed consent. All participants under 18 years of age must have the informed consent of a parent and must assent to participation.
✓. Has not received any prior doses of the HPV vaccine. Investigators will ask the patient and his/her parent (if \<18) about prior vaccination and check the state registry (Immtrac), as well as the UTMB electronic medical record (if previously seen at UTMB), investigators will check with their primary care provider, if feasible, for patients who are not a previously established UTMB patient.
✓. 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.
✓. Reliable telephone access.
✓. Participant and parent/ guardian (if \<18) can read and speak either English or Spanish.
Exclusion criteria
✕. 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 each Gardasil 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 the study and advised to seek prenatal care. If a subject is pregnant when her follow-up visit window closes, she will be removed from the study.
✕. History of 6 or more lifetime sexual partners.
What they're measuring
1
Short-term Human Papillomavirus (HPV) Type-specific Antibody Response for Type HPV-6
Timeframe: Month 7
2
Short-term HPV Type-specific Antibody Response for Type HPV-11
Timeframe: Month 7
3
Short-term HPV Type-specific Antibody Response for Type HPV-16
Timeframe: Month 7
4
Short-term HPV Type-specific Antibody Response for Type HPV-18
Timeframe: Month 7
5
Short-term HPV Type-specific Antibody Response for Type HPV-31
Timeframe: Month 7
6
Short-term HPV Type-specific Antibody Response for Type HPV-33
Timeframe: Month 7
7
Short-term HPV Type-specific Antibody Response for Type HPV-45
Timeframe: Month 7
8
Short-term HPV Type-specific Antibody Response for Type HPV-52
Timeframe: Month 7
Trial details
NCT IDNCT03943875
SponsorThe University of Texas Medical Branch, Galveston
. 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.
✕. Currently taking medication which can suppress immune function including systemic corticosteroids, radiation therapy, cyclophosphamide, azathioprine, methotrexate, cyclosporine, leflunomide, TNF-alpha antagonists, monoclonal antibody therapies, or intravenous immunoglobulin treatment.
✕. Known allergies to any components of the vaccine, including aluminum, yeast or Benzonase.
✕. Febrile at ≥100°F in the 24 hours prior to vaccination. This will be reviewed before each Gardasil 9 dose.
✕. Received any non-study inactive vaccines within the past 14 days or any live vaccines within the past 30 days. Those excluded for this reason will be re-screened under the same study number at a later date.
9
Short-term HPV Type-specific Antibody Response for Type HPV-58
Timeframe: Month 7
10
HPV Type-specific Antibody Response for Type HPV-6
Timeframe: Month 12
11
HPV Type-specific Antibody Response for Type HPV-11
Timeframe: Month 12
12
HPV Type-specific Antibody Response for Type HPV-16
Timeframe: Month 12
13
HPV Type-specific Antibody Response for Type HPV-18
Timeframe: Month 12
14
HPV Type-specific Antibody Response for Type HPV-31
Timeframe: Month 12
15
HPV Type-specific Antibody Response for Type HPV-33
Timeframe: Month 12
16
HPV Type-specific Antibody Response for Type HPV-45
Timeframe: Month 12
17
HPV Type-specific Antibody Response for Type HPV-52
Timeframe: Month 12
18
HPV Type-specific Antibody Response for Type HPV-58