Gardasil Vaccination in Post Stem Cell Transplant Patients
Condition: Gardasil Vaccine; Stem Cell Transplant; Immunogenicity
Intervention: Gardasil
Intervention description: 3 separate 0.5 ml intramuscular
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Women's Health; Genital Precancer; Stem Cell Donor; Cervical Cytology; Healthy Volunteers; Stem Cell Transplant; Healthy Volunteer; HV

Summary:

      Background:

        -  Gardasil , a recently approved vaccine for the sexually transmitted human papillomavirus
           (HPV), provides immunity to four types of HPV that are associated with genital warts and
           cervical, vaginal, and vulvar precancer and cancer. The vaccine has been shown to be
           highly effective in preventing infection with these HPV types and was approved for use
           by the Food and Drug Administration.

        -  More research is needed about the vaccine s ability to induce immunity in individuals
           with suppressed immune systems, such as those who have had other kinds of cancer
           treatment such as stem cell transplant. Genital warts, precancer, and cancer have been
           reported as a late complication after stem cell transplant. Researchers are interested
           in determining whether the HPV vaccine is safe to give and able to induce immunity in
           female stem cell transplant recipients, their female donors, and healthy female
           volunteers.

      Objectives:

      - To assess the safety and immune response of the HPV vaccine in female recipients of stem
      cell transplants who are either off or on stable doses of immunosuppression.

      Eligibility:

        -  Females between 18 and 50 years of age who have had allogenic stem cell transplants.

        -  Healthy female volunteers, including stem cell donors, are also eligible for this study.

      Design:

        -  Participants will be screened with a physical examination, blood and urine tests, and
           saliva samples, and will be asked to complete a sexual quality of life questionnaire.

        -  Sexually active participants will also have a routine gynecologic evaluation.

        -  Participants will receive three HPV vaccinations according to the standard vaccination
           schedule (with the second and third following 2 and 6 months after the first).
           Participants will record their daily temperature and any reactions to the vaccine on a
           vaccine report card for 1 week after each vaccination.

        -  Participants will have clinic visits for further testing 2, 6, 7, and 12 months after
           receiving the first HPV vaccine.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

        Female stem cell transplant recipient at least 90 days post stem cell transplant

        OR

        Female stem cell transplant recipient at least 90 days post HSCT and on immunosuppression

        OR

        The matched female stem cell transplant donor for an included stem cell transplant
        recipient

        OR

        Healthy female subject

        Age greater than or equal to 18 years and less than or equal to 50 years

        EXCLUSION CRITERIA:

        Vaccine Recipient:

        Obvious HPV condyloma or obvious severe dysplasia (greater than or equal to CIN II)
        warranting treatment

        History of severe adverse reaction to any components (yeast, eggs, monosodium glutamate or
        neomycin) of the quadrivalent HPV vaccine.

        Untreated or persistent life-threatening infections not controlled by current treatment

        Uncontrolled chronic GVHD i.e. highly active eGVHD requiring immediate intervention

        Pregnant or breast feeding or unwilling to be abstinent or practice effective contraception
        during the study period (note: patients who have been rendered infertile with total body
        irradiation are eligible)

        Enrollment in another vaccine clinical trial during the study period

        Enrollment of healthy volunteer in a drug clinical trial during the study period

        Inability to comprehend the investigational nature of the study and provide informed
        consent<TAB>

        Prior Gardasil or other HPV vaccination

        Persistent or recurrent malignancy