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Human Papillomavirus Antibody Response After GARDASIL 9 Vaccination in Participants After Allogeneic Stem Cell Transplantation (NCT03023631)

Merck Sharp & Dohme Corp.
University Cancer Foundation
Duncan Family Institute for Cancer Prevention and Risk Assessment
The goal of this clinical research study is to learn if Gardasil (the HPV vaccine) can prevent HPV infection and HPV-related disease when given to blood cancer patients who have received a stem cell transplant.
  • Biological: GARDASIL 9
    GARDASIL 9 administered as 3 separate 0.5-mL doses under the skin in the arm or thigh at about 6 months (+/- 8 weeks) after the stem cell transplant, then again about 2 months after the first injection, and then again about 4 months after the second injection.
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    Inclusion Criteria:
    • All English-speaking adult (18 years and older) MD Anderson patients with hematologic malignancy at 6-12 months +/- 8 weeks post allogeneic stem cell transplantation who will receive usual post-stem cell transplant vaccinations.
    • All patients from approved protocol 2015-0795 will be invited to this vaccine study.
    Exclusion Criteria:
    • Prior allogeneic SCT
    • Platelet count less than or equal to 25,000 K/µL.
    • Absolute neutrophil count less than or equal to 500/µL.
    • Patients who have ever received HPV vaccination (at least one dose of HPV vaccine).
    • Patients with a prior history of HPV-related malignancy.
    • Female patients who tested positive for pregnancy during pre-SCT evaluation.
    If participant agrees to take part in this study, about 6-12 months after their stem cell transplant:

    - Participant will receive Gardasil as 3 injections at 3 separate timepoints under the skin in the arm or thigh. Participant will receive the vaccinations at about 6 months (+/- 8 weeks) after the stem cell transplant, then again about 2 months after the first injection, and then again about 4 months after the second injection.

    - Blood (about 1 tablespoon) will be drawn to test for HPV antibodies before the first vaccination, and again at 1 month and 6 months after that. HPV antibodies are created by the immune system and may protect participant against infections such as HPV-related disease in the future.

    Participant will be given a dosing diary to record any side effects after each vaccination.

    Follow-Up:

    Participant will be called within 3 days after each vaccination and asked about how they are doing and about any side effects. If the doctor thinks it is needed, participant will visit the clinic for a physical exam.

    Length of Study:

    Participant will receive up to 3 vaccinations. Participant will not receive all 3 vaccinations if the disease gets worse, if intolerable side effects occur, or if they are unable to follow study directions. Participation on this study will be over after participant's last follow-up phone call (within 3 days after their third vaccination).

    This is an investigational study. Gardasil is FDA approved and commercially available for the prevention of HPV infection and HPV-related disease. Studying the effectiveness of Gardasil after patients have received a stem cell transplant is considered investigational. The study staff can explain how Gardasil is designed to work.

    Up to 48 participants will be enrolled in this study. All will take part at MD Anderson.

    1 locations

    United States (1)
    • University of Texas MD Anderson Cancer Center
      recruiting
      Houston, Texas, United States, 77030
    Status:
    recruiting
    Type:
    Interventional
    Phase:
    Start:
    22 April, 2017
    Updated:
    23 April, 2017
    Participants:
    48
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